Molecular Partners Completes GMP Manufacturing of Anti-COVID-19 DARPin® Candidate MP0420 for Clinical Use
Zurich-Schlieren, Switzerland, September 14, 2020. Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin® therapeutics, today announced the completion of initial Good Manufacturing Practice (GMP) manufacturing runs of its tri-specific, antiviral DARPin® candidate for COVID-19, named MP0420. More than 1 kg of DARPin® material was produced in each of the 100 liter E.coli-based bacterial fermenter runs. This fermentation approach is relatively simple, rapid and scalable compared to typical antibody manufacturing approaches, further differentiating the DARPin® approach as a potential therapeutic and prophylactic option for COVID-19.
“We believe the highly distinct manufacturing profile of DARPin® candidates is a crucial element for successful therapeutic efforts underway. Given the number of teams pursuing therapeutic approaches to the novel coronavirus, and considering the need to make a drug available on a global basis, it is essential to demonstrate the ability to manufacture and deploy these medicines,” said Patrick Amstutz, PhD, chief executive officer of Molecular Partners. “Beyond the unique tri-specific mechanism and sub-picomolar potency demonstrated in vitro, our first GMP batches now support a target product profile for a COVID-19 candidate with simple, scalable manufacturing that could rapidly meet global need. We will further evaluate optimal dosage in our Phase 1 study initiating this fall.”
Characteristics of DARPin® Therapeutics make them ideally suited for antiviral therapies, particularly at time of global need. Offering logistical solutions that other potential therapeutics in development may not possess, including:
- Sub-picomolar potency, allowing investigation of subcutaneous administration as both early intervention and potential prophylaxis*
- Highly scalable microbial manufacturing, allowing for up to 4 production runs on the same fermenter, per month
- High temperature stability of DARPin® drugs (>80°C) which may allow for avoidance of cumbersome cold chain storage
Bacterial fermenters can range upwards of 10,000L in size. A single such fermenter could enable the delivery of hundreds of thousands of doses of MP0420 on a monthly basis, if initial GMP yields and production speed are maintained.
First in human studies for MP0420 are anticipated to begin in November, 2020. Additional manufacturing slots have been secured over the next 6 months, including production in 1000L fermenters. These slots will be used to produce additional doses for MP0420, as well as for our second antiviral candidate for COVID-19, MP0423, with clinical studies anticipated in H1 2021.