Aug 12 2020
· Swiss Government will pay a reservation fee for the right to purchase up to 3.2 million doses of anti-COVID-19 DARPin® candidate, MP0420, for both therapeutic and potential prophylactic use
· Purchase of these doses may occur following appropriate marketing authorization
· Multi-specific antiviral program demonstrates best-in-class potency against live SARS-CoV-2 virus; Recent in vivo data additionally supportive of clinical development
· Initial clinical studies planned for Q4 2020
Zurich-Schlieren, Switzerland—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 the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of a defined number of initial doses of the company’s multi-specific DARPin® anti-COVID-19 candidate, MP0420. MP0420 builds on a unique three-in-one DARPin® architecture to enhance potency and with the potential to prevent viral escape, in addition to manufacturing process advantages.
“The Swiss Government’s support in advancing our novel antiviral DARPin® program is an encouraging signal as we rapidly build upon our strong preclinical data that shows best-in-class potency in neutralizing live virus and recently secured manufacturing capacity,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “We have been able to confirm activity in a relevant in vivo model supporting the potential of our unique tri-DARPin® for tackling SARS-CoV-2, as we believe novel therapeutics will be an essential tool for addressing the COVID-19 global pandemic.”
The initial supply agreement secures the right to purchase 200,000 doses, with the potential to purchase up to an additional 3 million doses. Certain pricing provisions have been pre-negotiated, but remain subject to final therapeutic dose. Under the terms of the agreement, the Company will immediately receive a reservation fee in the high single digit millions Swiss Francs. This will secure priority access for the Swiss government to purchase reserved doses of MP0420, if clinical trials are successful and MP0420 is approved in Switzerland.
Molecular Partners has selected a lead candidate (MP0420) and a variant molecule for preclinical development. Recently the Company announced completion of in vitro potency assessments of its DARPin® candidates targeting live, replicating SARS-CoV-2 virus. These candidates showed extremely robust antiviral activity, with several candidates demonstrating complete neutralization with low picomolar potency. This suggests only small amounts of these candidates may be required for therapeutic effect, which complements the company’s ability to rapidly manufacture DARPin® candidates with high yields using relatively simple E.coli-based biofermentation. The company has secured large-scale GMP manufacturing with AGC Biologics with an initial capacity of 100 liters and up to 1000 liters over the longer-term, a scale which Molecular Partners estimates is suitable for development and initial global supply of patients in need.
The company plans to initiate clinical studies for the anti-COVID-19 program in Q4 2020.
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. These building blocks target different sites on the virus, including blocking binding to the human ACE2 receptor (Receptor Binder Domain or RBD), the virus’s primary docking mechanism to host cells and allosteric inhibition, or “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 allows for cooperative binding and with that unrivaled 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 candidates will profit from high-yield and low-cost microbial manufacturing. It will be investigated if the high thermal stability can be used to overcome cold-chain requirements.
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.
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 registration via the development of abicipar, Molecular Partners’ most advanced DARPin® drug candidate. 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 is a clinical-stage biotech company developing a new class of custom-built protein therapeutics 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.