Candidates: MP0420 and MP0423
Types: Multi-targeted direct acting antiviral therapeutic candidates developed through Molecular Partners’ DARPin® platform. DARPins are non-antibody-based small proteins where a variable region has been engineered for target binding.
Status: Novartis said October 28 it agreed to develop, manufacture, and commercialize Molecular Partners’ anti-COVID-19 DARPin® program, consisting of MP0420 and MP0423. The CHF 210 million ($234 million) collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis broad expertise in global drug development, regulatory affairs, manufacturing and commercialization in order to develop the drugs for prevention and treatment of COVID-19.
The companies’ option and license agreement creates an option period, during which Molecular Partners has agreed to conduct Phase I clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423. Novartis has agreed to conduct Phase II and Phase III clinical trials, to be sponsored by Molecular Partners. Upon exercise of its option, Novartis would be responsible for all further development and commercialization activities.
During the clinical development stage, Molecular Partners has agreed to provide clinical supply, while the companies have agreed to work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply.
According to Novartis, DARPin® therapeutics are ideally suited for antiviral therapy for reasons that include multi-specific target binding with the potential to prevent viral escape via mutations; the possibility for subcutaneous administration; long half-life for sustained activity; the potential to bypass cold storage; and typically high-yield, highly scalable production in bacterial fermenters.
Novartis agreed to pay Molecular Partners CHF 60 million ($67 million), including equity, upfront, and CHF 150 million ($167 million) upon Novartis exercising its option to both therapeutic candidates, plus “significant” royalty on sales. Molecular Partners agreed to forgo royalties in lower income countries, and has agreed with Novartis “to ensure affordability based on countries’ needs and capabilities,” Novartis added.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: