Novartis to Develop Direct-Acting COVID-19 Antiviral Therapies

Novartis and Molecular Partners AG recently announced a collaboration in the form of an option and license agreement to develop, manufacture, and commercialize Molecular Partners’ anti-COVID-19 DARPin program, consisting of two COVID-19 antiviral therapies.  

The collaboration will leverage Molecular Partners’ proprietary DARPin technologies and Novartis’ expertise in global drug development, regulatory affairs, manufacturing, and commercialization to advance the program in light of the ongoing pandemic. 

“This pandemic calls for not just scientific solutions, but also for collaboration between companies to provide treatments in an area of high unmet need,” Vas Narasimhan, chief executive officer of Novartis, said in the announcement. 

“This Swiss led partnership, which could deliver both prophylactic and treatment options at scale for COVID-19 patients across the globe, is another demonstration of our sustained commitment to addressing one of the greatest health challenges of our time,” continued Narasimhan. 

Molecular Partners created a class of custom-built protein therapeutics, which are known as DARPin therapeutics. The protein therapeutics can expand the reach of conventional protein and antibody-based approaches.

DARPin has many characteristics that are important for antiviral therapy, Novartis said. These characteristics include multi-specific target binding with the potential to prevent viral escape through mutations, the possibility for subcutaneous administration, and the potential to bypass cold storage, scalable production in bacterial fermenters. 

The therapeutic type will be key to quickly developing the two potential COVID-19 antiviral therapies and getting the treatments to patients worldwide, the companies emphasized.. 

“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, DARPins have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic,” said Patrick Amstutz, chief executive officer of Molecular Partners.

“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,” Amstutz stated

The potential COVID-19 therapies, MP0420 and MP0423, have the possibility of being manufactured at scale and may bypass cold storage. Under the agreement, Molecular Partners will conduct Phase 1 clinical trials for MP0420, which are expected to begin this month. 

Additionally, the company will perform all remaining preclinical work for MP0423, while Novartis will conduct Phase 2 and Phase 3 clinical trials with Molecular Partners as the sponsor. 

Novartis will be responsible for all future development and commercialization activities of the therapies. And during the clinical development stage, Molecular Partners will provide clinical supply. 

Together, the companies will work to scale-up manufacturing capacity to provide supply worldwide. Sandoz will participate in the scale-up as well. 

Under the terms of the agreement, Molecular Partners will receive an upfront payment of CHF 60 million, including equity, while Molecular Partners will receive a further payment of CHF 150 million. 

Experts believe that the next generation of cell therapies holds significant promise for patients because it creates a point-of-care treatment that may potentially cure many illnesses.