Molecular Partners Presents Preclinical Data Supporting Tumor Localization Mechanism of its CD40 Agonist MP0317 at World Bispecific Summit

Molecular Partners Presents Preclinical Data Supporting Tumor Localization Mechanism of its CD40 Agonist MP0317 at World Bispecific Summit

    • 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.

Molecular Partners Completes GMP Manufacturing of Anti-COVID-19 DARPin® Candidate MP0420 for Clinical Use

    • High yields in bacterial fermentation systems support ability of DARPin® manufacturing to rapidly scale for global supply
    • First and only, tri-specific antiviral demonstrating potential best-in-class potency in vivo
    • First-in-human clinical trial initiation planned for November 2020

Zurich-Schlieren, Switzerland, September 14, 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 completion of initial Good Manufacturing Practice (GMP) manufacturing runs of its tri-specific, antiviral DARPin® candidate for COVID-19, named MP0420. More than 1 kg of DARPin® material was produced in each of the 100 liter E.coli-based bacterial fermenter runs. This fermentation approach is relatively simple, rapid and scalable compared to typical antibody manufacturing approaches, further differentiating the DARPin® approach as a potential therapeutic and prophylactic option for COVID-19.

“We believe the highly distinct manufacturing profile of DARPin® candidates is a crucial element for successful therapeutic efforts underway. Given the number of teams pursuing therapeutic approaches to the novel coronavirus, and considering the need to make a drug available on a global basis, it is essential to demonstrate the ability to manufacture and deploy these medicines,” said Patrick Amstutz, PhD, chief executive officer of Molecular Partners. “Beyond the unique tri-specific mechanism and sub-picomolar potency demonstrated in vitro, our first GMP batches now support a target product profile for a COVID-19 candidate with simple, scalable manufacturing that could rapidly meet global need. We will further evaluate optimal dosage in our Phase 1 study initiating this fall.”

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:

  • Sub-picomolar potency, allowing investigation of subcutaneous administration as both early intervention and potential prophylaxis*
  • Highly scalable microbial manufacturing, allowing for up to 4 production runs on the same fermenter, per month
  • High temperature stability of DARPin® drugs (>80°C) which may allow for avoidance of cumbersome cold chain storage

Bacterial fermenters can range upwards of 10,000L in size. A single such fermenter could enable the delivery of hundreds of thousands of doses of MP0420 on a monthly basis, if initial GMP yields and production speed are maintained.

First in human studies for MP0420 are anticipated to begin in November, 2020. Additional manufacturing slots have been secured over the next 6 months, including production in 1000L fermenters. These slots will be used to produce additional doses for MP0420, as well as for our second antiviral candidate for COVID-19, MP0423, with clinical studies anticipated 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

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.

Molecular Partners to Present at HC Wainwright and Morgan Stanley Healthcare Conferences

Zurich-Schlieren, Switzerland, September 11, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin® therapeutics, today announced that Patrick Amstutz, chief executive officer, will be presenting at the HC Wainwright 22nd Annual Global Investments Conference taking place September 14-16, 2020, as well as participating in a fireside chat at the Morgan Stanley Global Healthcare Conference taking place September 14-18, 2020.

Details for the presentations are as follows:

HC Wainwright 22nd Annual Global Investments Conference

Presentation Date:           Monday, September 14, 2020

Presentation Time:           11:30 a.m. ET

 

Morgan Stanley Global Healthcare Conference

Presentation Date:           Wednesday, September 16, 2020

Presentation Time:           1:15 p.m. ET

 

A webcast of the presentations will be available on the Molecular Partners website.

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 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