The DARPin therapeutics program developed by Molecular Partners is a new class of custom-built protein drugs comprising of two multi-targeted direct-acting antiviral therapeutic candidates, MP0420 and MP0423, designed for potential use against COVID-19. 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.
In collaboration with Novartis, the Schlieren-based clinical-stage company will leverage its proprietary DARPin technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization.
Phase 1 trials to kick off in November 2020
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. Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as a 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.
Novartis invests in Molecular Partners
Further terms of the agreement state that Molecular Partners will receive a cash payment of CHF 20 million. As part of the transaction, Novartis also agreed to acquire CHF 40 million worth of ordinary shares with immediate effect, at a price of CHF 23 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 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.
“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.