Molecular Partners Shares New Preclinical Data from its AML-Focused CD3 T-Cell Engager Program, CD40 Product Candidate MP0317, and Other Novel Immuno-oncology Approaches at AACR

Molecular Partners Shares New Preclinical Data from its AML-Focused CD3 T-Cell Engager Program, CD40 Product Candidate MP0317, and Other Novel Immuno-oncology Approaches at AACR

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  • Data support potential of DARPin® CD3 T-cell engager candidate for improved safety window while limiting tumor escape
  • New data show that the FAP x CD40 product candidate, MP0317, led to a localized macrophage repolarization and reversion of T-cell suppression. Clinical trials expected to initiate in the second half of 2021
  • Effector control technologies give new potential for enhancing current and future immunotherapies while reducing toxicities

Zurich-Schlieren, Switzerland, April 10, 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, today announced the presentation of four posters highlighting research across its immuno-oncology programs at the American Association for Cancer Research (AACR) virtual Annual Meeting. The preclinical data shared include results from the Company’s acute myeloid leukemia (AML) CD3 T-cell engager program, new data from the MP0317 (FAP x CD40) tumor localized immune activator, and initial results from the Company’s CD3 prodrug programs.

“With our new technologies designed for localized immune activation, targeting of cell surface-displayed peptides derived from intracellular proteins, and T-cell engagement, we believe we have a solid strategy for our new immune-oncology product candidates, and novel design capabilities that have the potential to greatly benefit our own and partnered immuno-oncology programs,” said Daniel Steiner, Ph.D., SVP Research of Molecular Partners. “Our first T-cell engager program is focused on AML, where statistically about half of people diagnosed relapse after treatment and die from the disease. Despite the existence of approved therapies, patients are often unable to benefit from these treatments due to intolerable toxicity. We believe we have made significant progress toward finding a way to avoid this trade-off and widen the therapeutic window for T-cell engagers in AML, aiming to deliver deeper and broader anti-tumor effect and reduce the impact on patients’ healthy cells.”

In preclinical studies, the Company’s AML candidates demonstrated substantial activity against different populations of AML cells in vitro, without significant damage to healthy cells. As shown in the poster titled Novel multi-specific DARPin® T-cell engager with an improved therapeutic window to overcome dose limiting toxicities in AML therapies, Molecular Partners is building on the strength of the DARPin® platform to create a single product designed to target three different cancer antigens simultaneously (CD70, CD33, and CD123). The multi-specific DARPin® T-cell engager candidate is designed to deliver highly potent and specific activity on AML cells, with a reduced effect on healthy normal cells, and with the potential to counteract target escape mechanisms expected due to tumor heterogeneity. In an ex vivo assay using fresh blood from healthy donors, the candidate induced profoundly less inflammatory cytokine production and reduction in platelet counts, unlike simultaneously tested T-cell engager candidates in development by other parties. We believe these data support the designed capability of this candidate to kill a broader population of AML cells while decreasing risk of toxicity.

The T-cell engager research presented today also displays the Company’s prodrug DARPin® technology for tumor-localized release of immune stimulation, through incorporation of a protease cleavable blocker DARPin® molecule. As CD3-binding T-cell engagers are highly potent and can lead to systemic toxicities, Molecular Partners has developed a DARPin® domain designed to mask the CD3 engager from interacting with T cells systemically/outside of the tumor. This technology is aimed at focusing the power of the effector function and reduce toxicities by controlling the location of activation to the tumor microenvironment. In a poster titled A solution to T-cell engager toxicity: An anti-CD3 Prodrug DARPin® (CD3-PDD) shows no toxicity, but potent anti-tumor activity in a humanized mouse model, Molecular Partners presents an anti-CD3 Prodrug DARPin® molecule, CD3-PDD, consisting of an EGFR-binder and a CD3-binder, linked via a protease-cleavable linker to a DARPin® domain masking the CD3 effector function. This-anti EGFR x anti-CD3 – Blocker Prodrug is shown to be unable to bind and recruit T-cells in its non-cleaved state in circulation, and is designed to become activated in the tumor microenvironment upon cleavage of the linker by tumor-associated proteases.

With respect to MP0317, a multi-specific DARPin® product candidate targeting both FAP and CD40 to enable tumor-localized immune activation, new preclinical data demonstrated a localized activation of immune cells in vitro, as well as ex vivo in human tumor samples, dependent on the presence of the FAP protein, which is highly expressed in the stroma of a broad range of solid tumors. The data presented in the poster titled MP0317, a FAPxCD40 targeting multi-specific DARPin® therapeutic, drives immune activation and leads to macrophage repolarization in vitro and ex vivo shows that MP0317 led to macrophage repolarization and reversion of T cell suppression: MP0317 led to upregulation of CD80, an M1 marker, and downregulation of CD163, an M2 marker, only in the presence of FAP, indicating macrophage repolarization towards an M1 phenotype. Furthermore, when these repolarized macrophages were co-cultured with T cells, T cell suppression was shown to revert and CD8 T-cell activation was observed, as shown by the increase of CD25. In both assays the killing effect was comparable to that achieved by an anti-CD40 antibody. We believe these data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation while avoiding systemic toxicity seen in other agents. MP0317 is anticipated to begin clinical trials in the second half of 2021.

Finally, with respect to the Company’s peptide-MHC targeting program, the Company presents preclinical results from a proof of concept study targeting a peptide derived from the NY-ESO-1 protein displayed in the context of a HLA-A2 molecule (a human MHC protein). The poster, Application of the DARPin® technology for specific targeting of tumor-associated MHC class I: peptide complexes, highlights results demonstrating rapid and reliable generation of DARPin® proteins against pMHC which were then formatted into bispecific T-cell engagers, and engineered to enable potent and specific activation of T cells. Further, the results show that the pMHC-targeting DARPin® candidate was able to achieve systemic half-life extension with limited impact on potency.

The posters presented at AACR are available to view in the Scientific Presentations section of Molecular Partners’ corporate website.

 

About Molecular Partners’ Immuno-oncology Product Candidates

Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin® technologies potentially applicable against a wide range of tumor types, including DARPin® candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin® platform, to provide precise control over immune activation and potentially enable more effective cancer immunotherapies.

 

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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Announces First Patient Dosed in a Phase 2 Clinical Trial of Ensovibep in COVID-19 Patients

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  • First study of ensovibep in patients with symptomatic COVID-19 disease
  • Designed to evaluate dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep
  • Ensovibep is additionally planned to be tested in two global, placebo controlled, double blinded trials: A Phase 2-3 trial in an ambulatory patient setting (named EMPATHY),
    and a Phase 3 trial in a hospitalized patient setting sponsored by the NIH (ACTIV-3)

Zurich-Schlieren, Switzerland, April 06, 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, today announced that the first patient has been dosed in a Phase 2a clinical trial of ensovibep, a DARPin® therapeutic candidate designed to bind to the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. The single arm study will enroll patients with symptomatic COVID-19, and is designed to evaluate dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep. The study, recruiting in the Netherlands, is designed to enroll up to 40 patients in two dose cohorts.

“In this first trial of ensovibep in patients, we hope to gain an early look at the viral clearance and the pharmacodynamic behavior of our lead COVID-19 candidate in the presence of the virus. Our preclinical trials with ensovibep have shown that it was able to bind and neutralize SARS-CoV-2 viruses both in vitro and in vivo, including against all currently known mutations of concern,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “As part of our development program, we aim to see if these results mechanistically translate into clinical efficacy in patients, with the current trial focused on examining viral presence in treated patients and the potential of the remaining virus to infect cells.”

In a Phase 1, randomized, double-blind, placebo-controlled single ascending dose study for safety, tolerability, and pharmacokinetics of intravenously administered ensovibep, run by Molecular Partners, initial data indicate that ensovibep is well tolerated with a half-life in the range of 2-3 weeks.

In partnership with Novartis, Molecular Partners aims to initiate additional clinical studies of ensovibep throughout the first half of 2021 with the goal of achieving clinical proof-of-concept and potential submission for emergency use authorization within 2021. The intended clinical program includes participation in the NIH’s ACTIV-3 clinical trial, as recently announced, as well as a global Phase 2-3 study (EMPATHY), which will seek to enroll over 2,100 patients in the ambulatory setting to evaluate the ability of ensovibep to prevent disease worsening, hospitalizations and death.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners’ two antiviral DARPin® candidates, ensovibep 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 COVID-19 prophylaxis and treatment. 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 DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer activity. All DARPin® candidates are constructed to benefit from high-yield and cost-effective manufacturing. Molecular Partners is investigating whether the high thermal stability of DARPin® molecules can be used to overcome cold-chain requirements.

In March 2021, the Company announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which showed that ensovibep was safe and well-tolerated with a half-life of 2-3 weeks. In October 2020, Molecular Partners entered into a collaboration with Novartis AG in the form of an option agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID‑19 DARPin® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for 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 those 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 ensovibep, 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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Publishes Invitation to Annual General Meeting 2021

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Zurich-Schlieren, Switzerland, March 26, 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, today published the invitation to the Annual General Meeting 2021.

The Annual General Meeting will be held on Wednesday, April 21, 2021, 2.00 pm CET, at the registered office of Molecular Partners AG, Wagistrasse 14, 8952 Schlieren, Switzerland.

In view of the current pandemic situation and in accordance with the applicable COVID-19 regulations, the Board of Directors of Molecular Partners AG has decided to conduct the Annual General Meeting without the physical presence of shareholders.

The Board of Directors greatly regrets that this decision was without alternative. As a result, shareholders of Molecular Partners AG may exercise their rights at the Annual General Meeting exclusively via written or electronically submitted instructions to the independent proxy.

  • Invitation to the Annual General Meeting 2021 with the corresponding agenda items
  • Einladung zur Generalversammlung 2021 mit den zugehörigen Traktandenpunkten

 

Financial Calendar

21 April 2021                      Annual General Meeting

12 May 2021                       Interim Management Statement Q1 2021

26 August 2021               Publication of Half-year Results 2021 (unaudited)

This calendar is always viewable at this link.

 

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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Nominates Dominik Höchli, M.D., for Election to its Board of Directors

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  • Pharmaceutical industry expert with extensive knowledge of R&D and commercialization

Zurich-Schlieren, Switzerland, March 25, 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, today announced the nomination of Dominik Höchli, M.D., to the Company’s Board of Directors proposed for election at the 2021 Annual General Meeting on April 21, 2021.

“As Molecular Partners continues to welcome a diverse set of talents to our company, we are pleased to propose Dominik for election to our Board of Directors. With an extensive skill set including global medical affairs, commercialization, and business strategy, we view Dominik as a welcomed addition to our Board, and look forward to his participation in the future success of our Company,” said Bill Burns, chairman of the Molecular Partners Board of Directors.

Dominik has 20 years of experience as a marketing and medical affairs executive. Until 2020 he worked at AbbVie as Vice President, Head of Global Medical Affairs and member of the R&D and the Commercial leadership team. He led global product launches for major blockbuster products, including HUMIRA, Maviret, Venetoclax and Skyrizi, and his leadership experience ranges from smaller country organizations and large global functions. He began his corporate career at McKinsey & Co. Dominik is a Swiss national and obtained his medical degree (M.D.) from the University of Bern.

 

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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Announces Intention to Conduct a Registered Offering in the United States

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Zurich-Schlieren, Switzerland, March 22, 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, today announced that it plans to conduct a registered public offering of its ordinary shares, in the form of American Depositary Shares (“ADSs”), in the United States and has confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission (the “SEC”). The timing, number of ADSs to be issued and the price of the ADSs to be issued in the proposed public offering have not yet been determined.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended (“Securities Act”). This announcement is being issued in accordance with Rule 135 under the Securities Act.

 

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.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners and Novartis Announce Inclusion of COVID-19 Antiviral Candidate, ensovibep, in NIH-Sponsored ACTIV-3 Trial

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  • ACTIV-3 trial planned to investigate safety and efficacy of ensovibep in adults hospitalized with a COVID-19 diagnosis; first patient dose expected in Q2 2021
  • Ensovibep to be first non-antibody therapeutic assessed in ACTIV-3
  • Clinical trial includes an interim analysis after 300 patients
  • Separately, a global Phase 2-3 study in adults with mild to moderate symptoms is planned to be initiated in Q2 2021
  • Initial Phase 1 data support safety, tolerability and 2-3 week half-life of ensovibep

Zurich-Schlieren, Switzerland, March 15, 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 that ensovibep (formerly MP0420) is expected to be included in a global phase 3 randomized, controlled clinical trial as part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial, ACTIV-3, is designed to evaluate the safety and efficacy of various therapies for the treatment of adults hospitalized with a COVID-19 diagnosis. Ensovibep is a DARPin® therapeutic candidate designed to bind to the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells, and may provide added protection against variant strains.

“The NIH’s ACTIV-3 trial provides a major expansion of ensovibep’s clinical program and data collection, and recognizes the clinical and preclinical evidence we have delivered to-date supporting this candidate as a differentiated approach to COVID-19 treatment,” said Patrick Amstutz, Ph.D., chief executive officer of Molecular Partners. “Emerging variant strains and the challenges of vaccinating a global population create an ongoing need for effective antivirals to save lives. We will work closely with both our collaborator Novartis and the NIH to maximize support on this trial in parallel with the other clinical trials of ensovibep planned to initiate in the second quarter.”

ACTIV-3 is one of multiple ongoing trials in the NIH’s ACTIV program, a public-private partnership designed to speed development of the most promising treatments and vaccine candidates for COVID-19. In order to be selected for ACTIV-3, Molecular Partners provided the NIH with relevant data and in addition provided ensovibep for independent preclinical assessments by the NIH. Molecular Partners has recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ensovibep.

Ensovibep is currently being evaluated in a Phase 1, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered ensovibep. Initial data from this study, run by Molecular Partners, indicate that ensovibep is well tolerated with a half-life in the range of 2-3 weeks.

In partnership with Novartis, Molecular Partners expects the initiation of additional clinical studies of ensovibep to initiate throughout the first half of 2021 with the goal of achieving clinical proof-of-concept and potential emergency use authorization within 2021. The intended clinical program includes a smaller Phase 2 trial specifically evaluating the ability of ensovibep to reduce infectivity, as well as a global Phase 2-3 study (EMPATHY), which will seek to enroll more than 2,000 patients in the ambulatory setting to evaluate the ability of ensovibep to prevent disease worsening, hospitalizations and death.

ACTIV-3 Clinical Trial Design

Once initiated, the ACTIV-3 trial arm evaluating ensovibep would initially enroll 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either ensovibep or placebo. Participants will also receive standard of care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants’ clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. If the ensovibep treatment arm appears to have a positive benefit:risk profile, the trial will enroll an additional 700 participants. Trial participants will be followed for 90 days following enrollment to analyze their response to treatment. The primary efficacy endpoint is the time from randomization to participants’ sustained recovery for 14 days after release from the hospital.

 

About Molecular Partners’ anti-COVID-19 program

Molecular Partners’ two antiviral DARPin® candidates, ensovibep 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 DARPin® domain that binds to human serum albumin (HSA) to support a longer half-life and hence longer 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.

In March 2021, the Company announced positive initial data from its Phase 1 study of ensovibep in healthy volunteers, which showed that ensovibep was safe and well-tolerated with a half-life of 2-3 weeks. In October 2020, Molecular Partners 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® candidates. Per the terms of the agreement, Molecular Partners will conduct Phase 1 clinical trials for 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 those 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 ensovibep, 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.

For more information see www.molecularpartners.com and 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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Nominates Agnete Fredriksen for Election to its Board of Directors

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  • Acknowledged innovation leader with deep scientific and business expertise in immunotherapy, oncology and infectious diseases

Zurich-Schlieren, Switzerland, March 11, 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, today announced the nomination of Agnete Fredriksen, Ph.D., to the Company’s Board of Directors proposed for election at the 2021 Annual General Meeting on April 21, 2021.

“We are pleased to propose Agnete for election to our Board of Directors during a time of growth and development for Molecular Partners, as we lay the foundations for an infectious diseases portfolio and new technologies for next-generation cancer immunotherapies to fruition,” said Bill Burns, chairman of the Molecular Partners Board of Directors. “We look forward to benefiting from her breadth of expertise across our deepening portfolio as we continue to expand the capabilities of our DARPin® platform.”

Agnete Fredriksen, Ph.D., is a co-founder, president and chief scientific officer of Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for cancer and infectious diseases. With prior roles at Affitech AS and Medinnova AS, Agnete’s focus is on developing vaccines from idea to clinical development. She is the author of numerous scientific papers in the field of immunology, immunotherapy and vaccines, and has been awarded several patents in the field of immunotherapy. She holds an MSc and a Ph.D. from the Institute of Immunology, Rikshospitalet Medical Center in Oslo, Norway.

 

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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners to Present Data from Localized Immune Agonist (MP0317), T-cell Engager, and Peptide-MHC Immunotherapy Programs at AACR Annual Meeting

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Zurich-Schlieren, Switzerland, March 10, 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, today announced the upcoming presentation of four posters with data supporting three of the company’s immunotherapy programs at the American Academy for Cancer Research (AACR) Virtual Annual Meeting running April 10-15, 2021.

The accepted research describes multiple aspects of validation for the unique mechanisms of these therapies in development for treating a wide range of tumor types.

Accepted abstract titles include:

MP0317 (targeting CD40 and FAP)

  • MP0317, a FAPxCD40 targeting multi-specific DARPin® therapeutic, drives immune activation and leads to macrophage repolarization in vitro and ex vivo

T-cell engager programs

  • Novel multi-specific DARPin® T-cell engager with an improved therapeutic window to overcome dose limiting toxicities in AML therapies.
  • A solution to T-cell engager toxicity: An anti-CD3 Prodrug DARPin® (CD3-PDD) shows no toxicity, but potent anti-tumor activity in a humanized mouse model

Peptide-MHC program

  • Application of the DARPin® technology for specific targeting of tumor-associated MHC class I: peptide complexes

For MP0317, the company’s multi-specific DARPin® candidate targeting both FAP and CD40 to enable tumor-localized immune activation, the research describes how the candidate’s activation of immune cells in-vitro, as well as on human tumor samples, was dependent on the presence of the FAP protein, which is highly expressed in the stroma of a broad range of solid tumors. Furthermore, the research observed that immunosuppressive macrophages associated with tumor growth and spread were reverted by MP0317 into an anti-tumor phenotype. These data support MP0317’s potential to deliver tumor-localized CD40-mediated immune cell activation avoiding systemic toxicity seen in other agents. MP0317 is anticipated to begin clinical trials in the second half of 2021.

For the T-cell engager program, two accepted research abstracts detail the construction of next generation T-cell engager DARPin® molecules designed to overcome the limited tumor specificity and the immune hyperstimulation associated with other T-cell engager approaches. By linking a T cell engaging CD3 DARPin® binder to additional DARPin® binder domains that optimally engage tumor-specific antigens in parallel, the company generated candidates that displayed strong in vitro potency, and low levels of cytokine release ex vivo – suggesting low systemic immune activation. Furthermore, an anti-CD3 Prodrug DARPin® (CD3-PDD) was successfully designed to have its immunostimulatory effects inactivated by a linked ‘blocking’ DARPin® domain, and become activated only in the tumor microenvironment, upon cleavage of the linker by tumor-associated proteases. In an in vivo humanized mouse tumor model, this candidate demonstrated anti-tumor activity and no toxicity when administered systemically. Together, the research supports Molecular Partners’ DARPin® technology ability to control immunostimulation through a validated mechanism with a heightened level of precision relative to existing approaches.

Finally, for the peptide-MHC (pMHC) program, the research provides updates on the development of pMHC binders in the T cell engager format. The successful screening and engineering of the bispecific DARPin® candidates (pMHC-CD3) achieved highly potent and specific T cell activation only in the presence of the target peptide, resulting in T-cell mediated tumor cell killing. A vast majority of tumor or viral antigens are presented as peptides on the cell surface by MHC molecules for immune cell recognition and have potential to be leveraged as versatile targets for immunomodulating therapeutics. However, to-date, antibody and T-cell receptor-based pMHC binders have been challenged by their low target abundance, weak affinity, cross-reactivity to other pMHCs, or challenging biochemical properties.

 

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.

For more information see www.molecularpartners.com and follow the Company on Twitter at @MolecularPrtnrs.

 

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

Thomas Schneckenburger, European IR & 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.

Molecular Partners and Novartis Report Positive Initial Results from Phase 1 Study of its COVID-19 Antiviral Therapy, Ensovibep, in Healthy Volunteers

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  • Initial findings show ensovibep to be safe and well tolerated with no significant adverse events
  • Predictable exposure seen post administration, confirming the expected half-life of 2‑3 weeks
  • Global phase 2/3 registrational study planned to initiate in Q2 2021

Zurich-Schlieren, Switzerland, March 09, 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 initial results from its ongoing phase 1 study of its first tri-specific COVID-19 antiviral treatment, ensovibep (MP0420), in healthy volunteers.

In the placebo-controlled phase 1 study, healthy volunteers were randomized 3:1 to receive an infusion of ensovibep, or placebo, respectively. Two dosing cohorts have been fully enrolled and received a single infusion of 3mg or 9mg per kilogram body weight, with 8 patients per dose cohort (16 total: 12 active, 4 placebo). In each of these cohorts, ensovibep was seen to be safe and well tolerated, with no significant adverse events reported. Preliminary results showed extended exposure of the DARPin® candidate in serum, with a half-life of 2-3 weeks, as was expected from preclinical experiments. These data confirm the systemic administration of a multi-specific DARPin® antiviral therapy to be safe and well tolerated, and support advanced plans for additional clinical work in positively diagnosed patients.

“We are excited to see the predictable exposure of ensovibep in this study. These data, coupled with the strong activity demonstrated preclinically against the major variants of SARS-CoV-2 in circulation, make it imperative that we move as quickly as possible to treating patients with our antiviral. These data now show that administration of a DARPin® candidate at these therapeutically relevant dose levels is possible with full consideration of safety and tolerability. We look forward to move rapidly to initiate our phase 2/3 global registration study with our partner Novartis, early in the second quarter of this year,” said Nicolas Leupin, M.D., CMO of Molecular Partners.

Per protocol, a third cohort in this phase 1 study, at a 20mg per kilogram dose level has been planned. As previously disclosed, this cohort has not been enrolled due to the “lock down” enforced in the UK due to the pandemic, starting at the end of 2020. It is possible this cohort can be enrolled in the coming weeks as restrictions lift, but Molecular Partners and Novartis have already identified the therapeutic dose levels which will be investigated in the upcoming clinical studies for infected patients, which are below the 20mg per kilogram dose level.

 

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 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 is conducting Phase 1 clinical trials for ensovibep and performing 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.

For more information see www.molecularpartners.com and 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

Thomas Schneckenburger, European IR & 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.

Molecular Partners Publishes Audited Financial Results for 2020 and Annual Report 2020

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Zurich-Schlieren, Switzerland, February 26, 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 published its audited Financial Results for 2020 and the company’s 2020 Annual Report.

The Audited Financial Results for 2020 and the company’s 2020 Annual Report are available on the investors section of the company’s 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:

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