• New study shows that Molecular Partners’ tri-specific antiviral DARPin® candidates, ensovibep (MP0420) and the Company’s preclinical candidate, MP0423, remain therapeutically active against the known mutations of SARS-CoV-2 including those present in the United Kingdom (UK) and South Africa (SA) variants
• Phase 2/3 clinical studies of ensovibep planned to initiate in Q2 2021

Zurich-Schlieren, Switzerland, February 04, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and its collaborator Novartis, today announced results from a study conducted at Spiez Laboratory. The study assessed leading SARS-CoV-2 anti-infective molecules, including the collaboration’s candidates ensovibep and MP0423, against new viral variants of SARS-CoV-2, including the variants first identified in the United Kingdom (UK) and South Africa (SA). These variants are associated with faster transmissibility and an ability to evade the immunity induced by some currently available vaccines and monoclonal antibodies. The study design and results were published on the research preprint service bioRxiv here.

The study showed that ensovibep maintained very high potency and activity on all tested viral variants and mutants. MP0423 maintained activity against all tested viral variants and mutants, but demonstrated a slight loss of potency against the UK variant, while remaining in the therapeutic range. These data indicate that ensovibep and MP0423 are potentially a better approach than monoclonal antibody approaches, many of which have previously reported significant potency loss.

“At Molecular Partners, we built our antiviral candidates to deal with the issue of viral escape, through targeting multiple sites on the virus at once with a single molecule. As designed, this approach is providing broad efficacy against SARS-CoV-2, even in the presence of emerging mutations, unlike approaches that only target single viral sites,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners. “These new data are highly encouraging as we look to initiate our global COVID-19 phase 2/3 registrational study in early Q2 2021 to establish our candidates’ emerging profile as potent antiviral agents with the possibility for early therapeutic intervention. Additional trials are under discussion to broaden the application space further, in other therapeutic settings. We and Novartis are committed to quickly bring our candidates to patients in need across the globe.”

In the study, based on a pseudovirion model, two new SARS-CoV-2 variants first identified in the United Kingdom (UK) (lineage B.1.1.7., del69-70, del145, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H) and South Africa (SA) (early evolved variant of lineage B.1.351.; D80A, D215G, E484K, N501Y, A701V), were analyzed for infectivity in the presence of different inhibitors. The Company’s two distinct multi-specific DARPin® candidates, ensovibep and MP0423, were shown to protect well against these variants, as well as against multiple individual point mutations previously described. Further analyses in context of the full Brazilian P.1 lineage are ongoing. Of note, key spike mutations from the newly emerged variants identified in UK and SA, as well as from the variant detected in Brazil (lineage P.1), E484K, 69/70-deletion and N501Y, were tested individually and in the context of the full variants as described above, and were inhibited by the two DARPin® candidates. These results are highly encouraging as the Company continues the clinical development of these candidates. Full data can be found in the bioRxiv publication linked above.

Ensovibep is presently in its ongoing phase 1 study which is expected to provide data in the first quarter of 2021.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners two antiviral DARPin® candidates, MP0420 and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. The benefits of this multi-specificity include cooperative binding, extremely high potencies and potential prevention of viral ‘escape’ via mutations. The candidates are formatted with a half-life extending DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

Following strong preclinical data supporting the anti-COVID-19 program candidates, in October 2020 the Company entered into a collaboration with Novartis AG in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for MP0420 (ensovibep) and perform all remaining preclinical work for MP0423; Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews

For Novartis multimedia content, please visit https://www.novartis.com/news/media-library

 

For further details, please contact:

Investors:

Seth Lewis
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

 

Media:

Shai Biran,  Ph.D.
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Stefan Riley
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Zurich-Schlieren, Switzerland, January 06, 2021. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that its Chief Executive Officer, Patrick Amstutz, Ph.D., will present at or attend several upcoming virtual healthcare investor events in January, 2021.

Conference Presentation Details:

• Event: H.C. Wainwright BioConnect 2021 Conference
• Date/Time: Monday, January 11, 2021 at 6:00 a.m. ET (12:00 p.m. CET)

• Event: Baader Helvea Swiss Equities Conference
• Date/Time: Wednesday, January 13, 2021 at 1:00 p.m. CET (7:00 a.m. ET)

• Event: JP Morgan 39^th Annual Virtual Healthcare Conference
• Date/Time: Thursday, January 14, 2021 at 7:30 a.m. ET (1:30 p.m. CET)

Conference Participation Details:

• Event: The Octavian Seminar 2021
• Date: Friday, January 15, 2021

All webcasted presentations will be made available on the Molecular Partners website.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas.

www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Shai Biran, Ph.D., IR & Comms
shai.biran@molecularpartners.com
Tel: +1 978 254 6286

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, Ph.D., IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

• First-in-human data from ongoing phase 1 study of MP0310 (AMG 506) demonstrate encouraging biological activity, including successful localized tumor engagement and saturation

• Data from ongoing phase 1 COVID-19 study show that MP0420 (ensovibep) is well tolerated in first dose cohort

• Unique immunomodulation platforms advanced to readiness for candidate generation using CD-3 T cell engagers and pMHC binders

• Virology portfolio launched with focus on major global viral threats where unique DARPin® therapeutic profile could make major impact

Zurich-Schlieren, Switzerland, December 17, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced multiple advances across clinical and preclinical programs, as well as an expansion of its corporate strategy to develop a portfolio of therapies targeting global viral threats. These advances will be detailed during a virtual R&D Day for investors and analysts starting at 9:00 a.m. ET on Thursday, December 17. (Registration link here)

“In 2020, we delivered several advances across our pipeline, including first clinical proof of a unique DARPin-mediated cancer-localized immune mechanism, de novo development and clinical entry for our COVID-19 program, and important platform advances for the design of new immunomodulatory multi-domain DARPin® molecules,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “We have dramatically expanded the capabilities of the DARPin® drug class and unlocked multiple new opportunities in immuno-oncology and virology, the latter of which we are pursuing given the momentum of our first antiviral candidates and the clear fit between the DARPin® therapeutic profile and the unmet need across multiple globally significant viral infections.”

In addition to senior management, Virtual R&D Day speakers will also feature Dr. Lutz Hegemann, M.D., Ph.D., Chief Operating Officer, Global Health, Novartis, and Mario Sznol M.D., Professor of Medicine (Medical Oncology); and Co-Leader, Cancer Immunology at Yale Cancer Center.

Corporate updates to be presented during the virtual event titled “Unlock and Expand: Custom Built Biology for Patients” will include:

Oncology: MP0310/AMG 506 (targeting 4-1BB x FAP)

• At the time of analysis, 19 of the 22 patients were available for evaluation. Of these, 50% of patients achieved stable disease (SD). To date, this multiple ascending dose, phase 1 study (0.5mg/kg-12mg/kg every 3 weeks) has reported no dose-limiting toxicities and no serious adverse events (SAEs) of special interest.
• Tumor biopsies confirm that MP0310 colocalizes to areas with high concentration of a tumor microenvironment-associated protein, fibroblast activation protein (FAP), which is a key characteristic of the mechanism of action. Additionally, significant increases in immune activation were seen across multiple immune cells, while inflammatory markers were unchanged, and no MP0310 activity was seen in peripheral tissues.
• Grade 2/3 infusion-related responses (IRRs) were observed in 12 patients and were manageable.
• Next steps will include investigating an optimized dosing schedule via exploration of weekly administration.

Oncology: MP0317 (targeting FAP x CD-40)

• Phase 1 initiation for MP0317 is now anticipated in H2 2021 due to a loss of drug supply associated with fill/finish procedures. New batches of MP0317 will be produced in H1 2021 and the clinical study is anticipated to initiate shortly thereafter.

COVID-19: MP0420 (ensovibep) (targeting three parts of SARS-CoV-2 spike protein)

• The phase 1 study of MP0420 is now enrolling the second of its 3 dosing cohorts. To date ensovibep has been seen to be well tolerated. The final dosing cohort is expected to enroll in the coming weeks and final data will be available in the first quarter of 2021.
• Additional clinical studies of ensovibep are planned to initiate throughout the first half of 2021, with the goal of achieving clinical proof of concept and potential emergency use authorization within 2021.

 Preclinical platforms expansion

• Advanced the peptide MHC (pMHC) therapeutics platform with data demonstrating high potency/specificity of research candidates and established half-life extension. These technical proofs-of-concept have resolved several major challenges of classical pMHC-targeted discovery and is now ready for therapeutic candidate generation.
• The T cell engager therapeutics platform has demonstrated both highly selective and targeted T cell engagement, context-dependent T cell engagement, and ‘slow release’ T cell engagement, giving multiple new levels of control over this powerful immunomodulatory mechanism.
• Additional data across these platforms are submitted for the upcoming American Association for Cancer Research (AACR) conference in April 2021.

A live webcast of the Virtual R&D Day will be available in the Investors section of the Company’s website at www.molecularpartners.com. An archived webcast recording of the event will be available on the website following the presentation.

 

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

New data from clinical and preclinical oncology programs to be presented

Preliminary Phase 1 data from anti-COVID-19 candidate MP0420 (ensovibep) expected

Zurich-Schlieren, Switzerland, December 02, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that it will host a virtual R&D Day for investors and analysts starting at 9:00 a.m. ET on Thursday, December 17.

Molecular Partners plans to share updates on its oncology programs and preliminary data from the Phase 1 study of MP0420, which is being developed for the treatment of COVID-19 under a collaboration with Novartis. In addition, Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners will describe the Company’s strategy for portfolio growth and expansion.

“This year we maintained momentum within our oncology portfolio while pushing our drug discovery platform to tackle the urgent medical need driven by the COVID-19 pandemic. The rapid progress from concept to clinical program initiation further underscores the potential of our expanding therapeutics platform to tackle new areas, such as infectious disease, and possibly help many more patients,” said Dr. Amstutz.

In addition to senior management, Virtual R&D Day speakers will also feature Dr. Lutz Hegemann, M.D., Ph.D., Chief Operating Officer, Global Health, Novartis, and Mario Sznol, M.D., Professor of Medicine (Medical Oncology); Co-Leader, Cancer Immunology, Yale Cancer Center.

A live webcast of the Virtual R&D Day will be available in the Investors section of the Company’s website at www.molecularparters.com. An archived webcast recording of the event will be available on the website following the presentation.

 

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Zurich-Schlieren, Switzerland, November 30, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that Dr. Patrick Amstutz, CEO of Molecular Partners, will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1, 2020 at 3:55 – 4:25 PM Eastern Time (9:55 PM CET).

The event will take place virtually, and audio webcast of the fireside chat will be webcast live and will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 90 days following the presentation.

 

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can be built to engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Zurich-Schlieren, Switzerland, November 23, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced that a first cohort of eight healthy volunteers has been dosed in a Phase 1 first-in-human study of MP0420 (ensovibep), a DARPin® therapeutic candidate for the potential treatment and prevention of COVID-19. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program.

“Our anti-COVID-19 program is aimed at delivering an efficacious, highly scalable, and globally distributable therapeutic that has the potential to both treat infected patients and protect high risk populations,” said Nicolas Leupin, M.D., Chief Medical Officer of Molecular Partners. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.”

Conducted in the United Kingdom, the trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered MP0420 in up to 24 healthy volunteers divided into three dose cohorts, with each cohort stratified 3:1 in favor of MP0420.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners two antiviral DARPin® candidates, MP0420 and MP0423, are designed to target multiple different sites on the SARS-CoV-2 virus simultaneously for enhanced antiviral effects and potential use as both prophylactics and treatments. The benefits of this multi-specificity include cooperative binding, extremely high potencies and potential prevention of viral ‘escape’ via mutations. The candidates are formatted with a half-life extending DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

Following strong preclinical data supporting the anti-COVID-19 program candidates, in October 2020 the Company entered into a collaboration with Novartis AG in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for MP0420 (ensovibep) and perform all remaining preclinical work for MP0423; Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

 

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can be built to engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. www.molecularpartners.com; Follow the Company on Twitter at @MolecularPrtnrs.

 

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Zurich-Schlieren, Switzerland, October 29, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, announced today its interim management statement for the period ending September30, 2020.

“Responding to the global COVID-19 pandemic requires an unprecedented effort on the part of therapeutics innovators like Molecular Partners. We have used our pioneering knowledge of the unique DARPin® class to rapidly deliver what could be the first multi-specific treatment options for patients, which have formed the basis for a pivotal collaboration with Novartis. Its global development, regulatory & commercial capabilities will help rapidly bring the program forward with the potential to change the face of the pandemic,” said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. “Our work to date along with this highly validating partnership encourage our pursuit of other new initiatives in virology, in addition to our innovative oncology programs. We believe this pipeline evolution is a continued demonstration of the strength of our DARPin® leadership that has opened new avenues for delivering therapeutics that can achieve clinical outcomes other modalities cannot.”

 

Research & Development Highlights

Virology:

• • Collaboration with Novartis for co-development of MP0420 and MP0423, including options for global commercialization; leveraging innovative protein drug development expertise of Molecular Partners with Novartis’ expertise in global development and commercialization

  • Terms of the Novartis agreement include total cash considerations of CHF 210 million ($230 million USD), comprised of an upfront payment, equity purchase, and milestones, as well as a 22% royalty on sales in commercial territories

  • Receipt of reservation fee from Swiss Government, securing a minimum of 200,000 doses of MP0420 with provisions for up to an additional 3,000,000 doses

  • First-in-human studies of MP0420 expected to begin in November 2020

Oncology:

• • Continued AMG 506 (MP0310) (FAP x 4-1BB) phase 1 dose escalation study. Presentation of initial data describing dosing, safety and proof of mechanism anticipated by the end of 2020, with potential initiation of combination studies by Amgen in H2 2021

  • MP0274 (HER2+) phase 1 study to conclude after dose escalation with no additional studies planned. In total, 22 patients were treated with MP0274, the drug was found to be safe and well tolerated with a PR as best response.

  • MP0317 (FAP x CD40) on track for Clinical Trial Application filing expected before the end of 2020 with First-in-human study start expected to begin in H1 2021

 

Financial highlights:

• • Gross proceeds of CHF 80.2 million from share capital increase received in July 2020, providing anticipated financing into 2022

  • Cash and short-term deposits of CHF 133.8 million as of September 30, 2020

  • Net cash used in operating activities of CHF 31.3 million in first nine months of 2020

  • Operating loss of CHF 38.3 million and net loss of CHF 41.2 million in first nine months of 2020

  • On December 17, 2020 the Company plans to host an Investor & Analyst Day, highlighting recent accomplishments in both clinical development and research. This event will be held virtually, and will include commentary from senior management and Key Opinion Leaders.

 

Antiviral program: Ongoing prioritized development of two highly differentiated anti-COVID-19 multi-DARPin® candidates with unique advantages

In the first half of 2020, the Company began leveraging its rapid discovery and candidate design capabilities to deliver multi-target binding DARPin® proteins that neutralized the SARS-CoV-2 virus in vitro. These two candidates, identified as MP0420 and MP0423, exhibit among the highest potency in inhibiting SARS-CoV-2 live virus reported to-date, and in the third quarter 2020 the Company disclosed strong preliminary in vivo findings for both candidates.

The DARPin® technology offer a differentiated approach to treating COVID-19 through a single molecule that can engage with the spike protein of the SAR-CoV-2 virus with three DARPin® modules simultaneously to neutralize the virus. This offers potentially broader efficacy – across both therapeutic and prophylactic settings – and reduced potential for the development of viral drug resistance which can result from mutations that change any single molecular target. DARPin® candidates are also produced through rapid, high-yield microbial fermentation for potential speed, cost and scaling advantages over more complex mammalian cell production typically employed for antibody production.

In July 2020, the Company announced a partnership with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization, to secure initial clinical and commercial-scale manufacturing capacity for the COVID-19 program. In August 2020, the Company announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of up to 3.2 million doses of MP0420, if the candidate is approved in Switzerland. Under the terms of the agreement, the Company immediately received a reservation fee in the mid to high single-digit millions of Swiss Francs.

In September, Molecular Partners completed the initial Good Manufacturing Practice (GMP) manufacturing runs of MP0420. More than 1 kg of DARPin® material was produced in each of the 100 liter E.coli-based bacterial fermenter runs.

In October, the Company announced further supportive preclinical data from in vivo assessments of its two DARPin® candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease. In a highly susceptible COVID-19 challenge model developed by expert virologists at Freie Universität Berlin, hamsters were first infected with SARS-CoV-2 and then administered either select doses of the two anti-COVID-19 DARPin® candidates or placebo, at either 0, 6, or 24 hours. In the five-day experiment, all animals treated with DARPin® molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression.

Further, on October 27, the Company signed a collaboration with Novartis (SWX symbol: NOVN) for the co-development of MP0420 and MP0423 as well as options for global commercialization. This collaboration combines the innovative protein drug development expertise of Molecular Partners with Novartis’ expertise in clinical development, manufacturing, regulatory affairs & commercialization to accelerate global development of both candidates.

Under the terms of the collaboration agreement, Molecular Partners received a cash payment of CHF 20 million (~$22 million USD). As part of the transaction, Novartis also agreed to acquire CHF 40 million (~$44 million USD) worth of ordinary shares at a price of CHF 23 (~$25 USD) per share. As a result, Novartis now holds approximately 6% of the outstanding shares of Molecular Partners. Molecular Partners is eligible to receive a future milestone payment of CHF 150 million (~$165 million USD), upon Novartis exercising the option to both therapeutic candidates, and 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries, and is aligned with Novartis’ plans to ensure affordability based on countries’ needs and capabilities.

Multiple characteristics of DARPin® therapeutics make them ideally suited for antiviral therapies, particularly at time of global need. Offering logistical solutions that other potential therapeutics in development may not possess, including (i) sub-picomolar potency, allowing investigation of subcutaneous administration as both early intervention and potential prophylaxis; (ii) highly scalable microbial manufacturing, allowing for up to 4 production runs on the same fermenter, per month; and (iii) high temperature stability of DARPin® drugs (>80°C) which may allow for avoidance of cumbersome cold chain storage. Molecular Partners is actively exploring opportunities to develop DARPin® therapeutics against other infectious diseases.

Immuno-oncology programs: Recruitment for AMG 506 (MP0310) continues in higher dose cohorts

Molecular Partners continued recruitment of patients with solid tumors in the ongoing phase 1 dose escalation study of AMG 506 (MP0310) (FAP x 4-1BB), in partnership with Amgen. AMG 506 (MP0310) is a tumor-localized immune agonist being evaluated in this phase 1 trial as a single agent in patients with advanced solid tumors. MP0310 includes localizer (FAP) and stimulator (4-1BB) DARPin® domains, which respectively provide tumor-specificity and immune activation. Initial presentation of data from the dose escalation cohorts are expected by year-end 2020 and will help inform potential phase 1b combination studies with Amgen assets which are anticipated to be conducted by Amgen.

For MP0317 (FAP x CD40), the Company’s second tumor-localized immune agonist, IND-enabling work continues to advance and Molecular Partners envisages a Clinical Trial Application (CTA) filing before the end 2020. A presentation at the World BiSpecific Forum in October 2020 underlined the mechanism of action and anti-tumor effects of this candidate.

For MP0274 (HER2+), after the completion of recruitment for the phase 1 trial already in the first half 2020, this trial will be concluded in Q4 2020. MP0274 is a multi-specific DARPin® product candidate being developed for the treatment of solid tumors with strong expression of the highly validated target protein HER2. In total 22 patients have received treatment with MP0274, one patient still continues on study. To date, MP0274 has been reported to be safe and well tolerated, and with one patient observed to have a Partial Response (PR). Presently, the Company does not plan any additional studies for MP0274.

For the phase 2 study of MP0250 (VEGF x HGF) in combination with the proteasome inhibitors (PIs) bortezomib (Velcade®) and dexamethasone in multiple myeloma, no new data were disclosed in the third quarter 2020 and no additional patients were enrolled into the study. The Company is evaluating potential clinical collaborations around MP0250, with updates anticipated before the end of 2020.

Abicipar

In Q3 2020, AbbVie withdrew its filings for abicipar with both the European Medicines Agency and the Japanese Regulatory Agency and is committed to working with these agencies to determine appropriate next steps and requirements for potential resubmissions for abicipar. Molecular Partners is in ongoing dialogue with AbbVie on the status of the program.

There is substantial need for better treatment options for nAMD and the Company remains confident in the totality of data supporting abicipar’s clinical profile for this indication, and continues to support AbbVie as it determines next steps.

Balance sheet: Strong cash and equity positions as of September 2020

Molecular Partners’ financial performance for the first nine months of 2020 reflects an operating cash outflow of CHF 31.3 million. In July 2020 the Company was able to reinforce its solid cash position with a private placement financing, raising gross proceeds of CHF 80.2 million. This further increases the Company’s financial flexibility to capture multiple value-creating inflection points into 2022. Moreover, in August 2020 Molecular Partners received a fee in the mid to high single digit millions of Swiss Francs from the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) as a purchase reservation fee for up to 3.2 million doses of MP0420.

As a consequence, cash and short-term deposits increased by CHF 69.4 million in Q3 2020 to CHF 133.8 million as of September 2020 (June 2020: CHF 64.4 million).

As of September 2020, the Company employed 143.4 FTEs, representing an 8% increase year-over-year, with approximately 85% of employees serving in R&D functions.

Business outlook and priorities

For the remainder of 2020, Molecular Partners will focus on advancing its immuno-oncology and infectious disease programs. For the COVID-19 program, the Company anticipates to start first-in-human studies for MP0420 in November 2020.

For AMG 506 (MP0310), following the planned reporting of initial data from the phase 1 study in December 2020, these data will be used to inform potential phase 1b combination studies with Amgen assets to be conducted by Amgen. For MP0317, the Company plans to file appropriate regulatory applications around the end of 2020 and expects to initiate clinical studies in the first half of 2021.

Financial outlook 2020

For the FY 2020, at constant exchange rates, the Company continues to expect total expenses in the range of CHF 65-75 million, of which approximately CHF 6.0 million will be non-cash effective costs. Capital expenditures in FY 2020 are expected to be approximately CHF 3.0 million.

Financial Calendar

• December 17, 2020    R&D Day
• February 5, 2021           Publication of FY 2020 results (unaudited)
• March 26, 2021              Publication of FY 2020 Annual report

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas. For more information regarding Molecular Partners AG visit www.molecularpartners.com or follow the company on Twitter @MolecularPrtnrs.

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

• • Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19

  • MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage

  • Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization

  • This collaboration strengthens Novartis’ ongoing commitment to research and partner with other companies to find and develop treatment options for COVID-19 and make them available around the world as fast as possible

Zurich-Schlieren, Switzerland, October 28, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, and Novartis (SIX: NOVN) today announced a collaboration in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of two therapeutic candidates, MP0420 and MP0423. The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

Novartis is making multiple contributions to the global efforts to combat the COVID-19 pandemic. As part of those efforts, it has become increasingly clear that to tackle the pandemic at a global level the development of medicines that can prevent and treat the virus, in addition to the development of vaccines, will be crucial. Multiple treatment options increase the likelihood of reaching and treating patients around the world and, in addition, may be especially important for certain populations at greater risk who may benefit from a prophylactic treatment. MP0420 and MP0423 are potential medicines for the prevention and treatment of COVID-19, with the possibility of being manufactured at scale and potentially bypassing cold storage.

“Novartis remains unwavering in its support for tackling COVID-19 and it is clear that this pandemic calls for not just scientific solutions, but also for collaboration between companies to provide treatments in an area of high unmet need. This Swiss led partnership, which could deliver both prophylactic and treatment options at scale for COVID-19 patients across the globe, is another demonstration of our sustained commitment to addressing one of the greatest health challenges of our time,” said Vas Narasimhan, Chief Executive Officer of Novartis.

Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423 and Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities. During the clinical development stage, Molecular Partners will provide clinical supply. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply.

Several characteristics of DARPin® therapeutics make them ideally suited for antiviral therapy including multi-specific target binding with the potential to prevent viral escape via mutations, the possibility for subcutaneous administration, long half-life for sustained activity, the potential to bypass cold storage and typically high-yield, highly scalable production in bacterial fermenters. These factors provide the possibility of developing and manufacturing this innovation at scale. This supports the commitment of both companies to leverage their respective strengths and expertise to urgently develop these two potential treatments and if the data are positive, facilitate access to these medicines for patients around the world as quickly as possible.

“Our team rapidly mobilized to deliver a unique DARPin®-based approach to address the overwhelming need for effective therapeutics against COVID-19. As a class, DARPin® therapeutics have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic. We have built on this long-term research with these two candidates, which have demonstrated extremely potent neutralization of the virus through inhibiting multiple viral mechanisms,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We are thrilled to partner with Novartis, who has shown great commitment to combatting this pandemic and bringing innovative solutions to people around the world.”

Collaboration Terms and Share Subscription

Under the terms of the agreement, Molecular Partners will receive a cash payment of CHF 20 million (~$22 million USD). As part of the transaction, Novartis also agreed to acquire CHF 40 million (~$44 million USD) worth of ordinary shares with immediate effect, at a price of CHF 23 (~$25 USD) per share. As a result, Novartis will hold approximately 6% of the outstanding shares of Molecular Partners.

Molecular Partners is eligible to receive a future milestone payment of CHF 150 million (~$165 million USD), upon Novartis exercising the option to both therapeutic candidates, and 22% royalty on sales. Molecular Partners has agreed to forgo royalties in lower income countries, and is aligned with Novartis’ plans to ensure affordability based on countries’ needs and capabilities.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

These building blocks are designed to target different sites on the virus for multiple concurrent effects. These include blocking viral binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the primary docking mechanism to host cells, as well as allosteric inhibition or “molecular handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates is designed for cooperative binding, extremely high potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

The ability of DARPin® products to be produced in E.coli-based biofermentation is a major advantage over antibodies, which often require substantial manufacturing process optimization and protein modification, significantly increasing cost and complexity. By contrast, DARPin® molecules are much smaller molecules that do not require glycosylation or extensive post-translational modification by producer cells, making simple, highly scalable bacterial fermentation feasible.

Molecular Partners is collaborating with AGC Biologics and Baccinex to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

 

About DARPin® therapeutics

DARPin® therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin® candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin® therapeutics have been clinically validated through to the registrational stage. The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin® is a registered trademark owned by Molecular Partners AG.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas. For more information regarding Molecular Partners AG visit www.molecularpartners.com or follow the company on Twitter @MolecularPrtnrs.

 

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis medicines reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

 

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

 

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

• • DARPin® candidates demonstrate 100% survival in an aggressive viral challenge model
  • Data support utility of anti-COVID-19 DARPin® candidates as potent therapeutics
  • First-in-human clinical trial initiation of MP0420 planned for November 2020

Zurich-Schlieren, Switzerland, October 6, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced supportive preclinical data from in vivo assessments of its DARPin® candidates targeting SARS-CoV-2. These candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease.

In a highly susceptible COVID-19 challenge model developed by expert virologists at Freie Universität Berlin, hamsters were first infected with SARS-CoV-2 and then administered either select doses of the anti-COVID-19 DARPin® candidates, MP0420 or MP0423, or placebo, at either 0, 6, or 24 hours. In the five-day experiment, all animals treated with DARPin® molecules recovered and survived, while 83% of animals in the placebo group had to be euthanized due to severe disease progression.

“The clinical efficacy observed in both prophylactic and post exposure settings, especially in the context of the severity of disease displayed by our novel COVID-19 model, holds promise for this class of virus-neutralizing inhibitors in later line settings,” said Jakob Trimpert, DVM, Ph.D., Freie Universität Berlin, Institute of Virology, who served as lead investigator of the study.

“These recent data underscore the potent mechanism of action of our DARPin® therapeutic candidates in both prophylactic and therapeutic animal models, opening the door for clinical trials in both settings. We now have evidence that our candidates may offer therapeutic benefit for patients receiving intensive care or in rapid decline,” said Patrick Amstutz, chief executive officer of Molecular Partners. “We would like to thank our collaborators in Berlin for pioneering this novel hamster model to test COVID therapies. This model might be the only one that mimics a severe disease progression in humans, as most hamsters become terminally ill as early as day two after viral infection.”

First-in-human studies for MP0420 are anticipated to begin in November 2020, and clinical studies for the second antiviral candidate, MP0423, are expected to initiate in H1 2021.

About Molecular Partners’ anti-COVID-19 program

Molecular Partners has developed a series of tri-specific antiviral DARPin® candidates with strong binding and neutralizing potency targeting multiple epitopes on the SARS-CoV-2 spike protein that are crucial for infection. The source of these constructs is a pool of hundreds of mono-DARPin® binders which individually bind and inhibit the virus with high potency. The construction of multi-specific candidates from monospecific proteins is the foundation of Molecular Partners’ drug discovery engine and has yielded multiple clinical candidates in other indications.

These building blocks are designed to target different sites on the virus for multiple concurrent effects. These include blocking viral binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the primary docking mechanism to host cells, as well as allosteric inhibition or “molecular handcuffing”, of the spike protein, preventing the conformational change it undergoes prior to injection of viral RNA into the human cell.

The formatting as tri-specific candidates is designed for cooperative binding, extremely high potencies and prevention of viral escape via mutations. The candidates are formatted with a half-life enhanced DARPin® domain that binds to human serum albumin (HSA) to support long-acting activity. All DARPin® candidates are constructed to benefit from high-yield and low-cost microbial manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

The ability of DARPin® products to be produced in E.coli-based biofermentation is a major advantage over antibodies, which often require substantial manufacturing process optimization and protein modification, significantly increasing cost and complexity. By contrast, DARPin® molecules are much smaller molecules that do not require glycosylation or extensive post-translational modification by producer cells, making simple, highly scalable bacterial fermentation feasible.

Molecular Partners is collaborating with AGC Biologics to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Stefan Riley, U.S. Media
stefan@tenbridgecommunications.com
Tel: +1 617 461 2442

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

• • MP0317 activates multiple antitumor immune cell types in vitro when in the presence of tumor stroma associated FAP
  • MP0317 mouse surrogate localizes to FAP-expressing tumors and induces strong and durable anti-tumor responses without systemic toxicity, and demonstrates strong anti-tumor immune memory responses

Zurich-Schlieren, Switzerland, September 24, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced the presentation of preclinical findings supporting the mechanism of MP0317, a tri-specific DARPin® product candidate that includes binding domains for fibroblast activation protein (FAP), CD40, and human serum albumin (HSA). The presentation, titled “Novel therapeutic design of tumor-targeted CD40 agonist DARPin® molecule leads to antitumor activity with limited toxicity”, will be presented today at 2pm (EDT) at the 11th Annual World Bispecific Summit by Clara Domke, a senior scientist oncology research at Molecular Partners.

Data presented demonstrate that a mouse surrogate MP0317 molecule induces FAP-dependent activation of B cells, dendritic cells and macrophages. FAP is expressed on activated cancer associated fibroblasts (CAF) and is overexpressed in the stroma of many solid tumors. Since MP0317 only activates these immune cells in the presence of FAP, MP0317 may avoid the dose-limiting side effects historically associated with systemic administration of CD40 antibodies. Additionally, in a FAP-positive colorectal cancer model, MP0317 induced complete tumor responses and demonstrated induction of an anti-tumor immunological memory, protecting the mice against subsequent tumor challenges without the need for additional treatment.

“Potent and situationally-activated antitumor therapies are an important new area for cancer treatment, when systemic toxicity can limit effective dosing of therapies with proven mechanisms like CD40 activation. With MP0317 we are tackling multiple kinds of cancer where highly fibrous, FAP-rich stromal tissue has historically presented a barrier to immune cell penetration. These data demonstrate the potential for turning this barrier into a target, by utilizing it as an anchor for the delivery of super-potent immunostimulatory molecules,” said Nicolas Leupin M.D., chief medical officer of Molecular Partners. “We look forward to filing appropriate regulatory applications for MP0317 around the end of 2020 and initiating clinical studies in the first half of 2021.”

The presentation will be made available on the company’s corporate website, www.molecularpartners.com.

About Molecular Partners’ Oncology Portfolio

DARPin® therapeutic candidates are uniquely versatile, custom-built molecules with the potential to help people suffering from a broad range of diseases, including cancer. Given their small size, multi-functional design and unique binding surfaces, DARPin® molecules can address molecular targets that have been difficult to access by other drug modalities, such as antibodies. Molecular Partners has delivered substantial proof-of-concept in its oncology portfolio by advancing investigational DARPin® therapeutics against highly validated targets such as HER2, HGF and VEGF into clinical studies. The Company has focused the next phase of its oncology portfolio strategy on exploring targets with novel mechanisms for selective and site-specific immune cell activation. Molecular Partners has designed DARPin® candidates to activate only when proximal to the target tumor, improving efficacy and potentially eliminating systemic off-target side effects. Promising immune modulators such as peptide-MHC complexes, 4-1BB and CD40 are also the target of novel DARPin® programs. Further, DARPin® approaches are applied to novel targets such as peptide MHC-complexes.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, designed to address challenges current modalities cannot. The company has compounds in various stages of clinical and preclinical development with a focus on oncology. Molecular Partners has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics across multiple therapeutic areas.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com

For further details, please contact:

Seth Lewis, SVP IR, Comms, & Strategy
seth.lewis@molecularpartners.com
Tel: +1 781 420 2361

Tom Donovan, U.S. Media
tom@tenbridgecommunications.com
Tel: +1 857 559 3397

Thomas Schneckenburger, IR & European Media
thomas.schneckenburger@molecularpartners.com
Tel: +41 79 407 9952

Forward-looking statements

This press release may contain certain forward-looking statements relating to the company and its business. Although the company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.