Swiss pharma giant Novartis is harnessing the power of Zurich-based Molecular Partners AG's DARPin platform to develop two therapeutic candidates that could both be used to prevent and treat COVID-19 infection.
This morning, the two companies announced a deal for the therapeutic candidates, MP0420 and MP0423. Molecular Partners is expected to begin Phase I studies of MP0420 within the next few weeks and will perform all preclinical work associated with MP0423. Once those studies are completed, Novartis will conduct Phase II and Phase III studies of MP0420 and assume all additional development activities for MP0423. As studies progress, both companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, Novartis’ generics and biosimilar division.
Molecular Partners has developed a series of tri-specific antiviral DARPin candidates with strong binding and neutralizing potency targeting multiple parts 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, according to the company. In comparison, antibody therapies in development against COVID-19 tend to only hit one target on the virus.
When COVID-19 became a global problem, Patrick Amstutz, CEO of Molecular Partners, said his team mobilized to develop a DARPin-based approach to address an overwhelming need for therapeutics against the novel coronavirus.
“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," Amstutz said in a statement.
In addition to the potential to target multiple parts of the virus, Molecular Partners was quick to point out that its DARPin candidates do not require cold-chain storage. That could be critical in treating COVID-19 patients in less-developed countries that do not have cold-chain infrastructure.
Novartis Chief Executive Officer Vas Narasimhan said the ongoing pandemic, which has infected more than 44 million people across the globe, has called for collaborations between companies to provide treatments in areas of high unmet need. Multiple treatment options increase the likelihood stemming the spread of the virus and may be especially important for certain populations at greater risk who may benefit from a prophylactic treatment, Narasimhan added. Novartis believes that MP0420 and MP0423 are potential medicines for the prevention and treatment of COVID-19, with the possibility of being manufactured at scale and potentially bypassing cold storage.
“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,” Narasimhan said in a brief statement.
Amstutz added that his company is thrilled to partner with Novartis, which he said has shown “great commitment to combatting this pandemic and bringing innovative solutions to people around the world.”
Under terms of the agreement, Novartis provided an upfront cash payment of about $22 million. Novartis also agreed to take a $44 million stake in the company at a price of $25 per share. That will give Novartis a 6% ownership in Molecular Partners. Additionally, if Novartis is able to commercialize both candidates, Molecular Partners stands to earn an additional $165 million in milestone payments. 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.
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