gorodenkoff
Molecular Partners (NASDAQ:MOLN) reported interim data from an ongoing phase 1 trial of MP0317 (FAP X CD40) program to treat patients with relapsed/refractory advanced solid tumors.
The company said MP0317 was seen to be safe and well tolerated with no dose limiting CD40-related systemic toxicities, and no signs of inflammatory cytokine release.
Four groups had received an intravenous dose of MP0317 every 3 weeks until disease progression, unacceptable toxicity or other discontinuation criteria were met, the company noted.
Molecular added that the most frequent adverse events were grade 2 infusion related reactions (such as, rapidly resolved infusion site inflammation) in 3/13 dosed patients at the time of data cutoff.
Tumor biopsies from the earlier cohorts (1-3) show MP0317 co-localization with both CD40 and fibroblast activation protein (FAP), in 3 of the 5 tumor biopsies available for analysis, according to the company.
"This first clinical data supports the potential of MP0317 as a candidate able to achieve the goal of restricting CD40 activity to tumors. We are now progressing into dosages well above those that produced dose-limiting toxicities with non-DARPin CD40 agents, a significant achievement we hope to translate into observed clinical effect," said Molecular CMO Nicolas Leupin.
The company added that early PD data show signs of CD40-mediated immune activation.
MOLN +4.44% to $6.59 premarket Nov. 10