Molecular Partners AG announced on Monday that it has completed initial manufacturing runs of its tri-specific, antiviral DARPin candidate for COVID-19, named MP0420.
Molecular (MLLCF) said that following the completion, it now expects to start first-in-human clinical trials in November this year. For now, more than 1 kg of DARPin material was produced in each of the 100 liter E.coli-based bacterial fermenter runs. The company noted that the fermentation approach is relatively simple, rapid and scalable compared to antibody manufacturing approaches.
Molecular Partners has developed a series of tri-specific antiviral DARPin candidates with binding and neutralizing potency targeting multiple epitopes 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 block the virus.
“We believe the highly distinct manufacturing profile of DARPin candidates is a crucial element for successful therapeutic efforts underway,” said Molecular CEO Patrick Amstutz. “Beyond the unique tri-specific mechanism and sub-picomolar potency demonstrated in vitro, our first 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.”
Molecular said that 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 the the company’s antiviral candidate for COVID-19, MP0423, with clinical studies anticipated in H1 of 2021.
Following last month’s 1Q results, JP Morgan analyst Richard Vosser reiterated a Hold rating on the stock with a $11 price target. (See MLLCF stock analysis on TipRanks)
Vosser noted that the company’s 2020 guidance implies extra costs, but he believes that the market will interpret this in the context of accelerating the anti-COVID-19 DARPin program and not see it as any cause for concern.
The one other analyst covering the stock over the past three months has a Buy rating on the stock with a $27.49 price target. The $19.24 average analyst price target puts the upside potential at 6% over the coming year.
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