Molecular Partners Announces Agreement with Swiss Government, Securing Rights to Purchase Doses of First Anti-COVID-19 DARPin® Program
Zurich-Schlieren, Switzerland, August 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 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.