Molecular Partners Collab Falls Victim to Amgen Strategic Pipeline Review

Michael Vi/Shutterstock

Michael Vi/Shutterstock

All development and commercialization rights for MP0310, a clinical stage immunomodulator intended to treat solid tumors, will be reverted to Molecular Partners.

Michael Vi/Shutterstock

A bittersweet end has been announced for a collaboration between Molecular Partners AG and Amgen.

The announcement details that all development and commercialization rights for MP0310, a clinical stage immunomodulator intended to treat solid tumors, will be reverted to Molecular Partners. The therapeutic utilizes Molecular Partners’ cost-effective and efficient DARPin drug discovery platform. The decision to end the agreement, made by Amgen, was attributed to a “strategic pipeline review.”

Molecular Partners CEO Dr. Patrick Amstutz expressed gratitude for four years of partnership, saying, “We would like to thank Amgen for a very fruitful collaboration which has led us to the initial clinical findings that an immunostimulatory receptor, such as 4-1BB, can be activated in a localized fashion. This collaboration has enabled us to broaden our immuno-oncology expertise, DARPin platform knowledge, and clinical development capabilities which are now being applied across our portfolio. We continue to anticipate the full Phase I dataset later this year, following which we can begin to explore potential collaborations for the program with new partners.”

The collaboration was first announced in 2018, with excitement stemming from the potential seen in MP0310. The agreement included royalty payments as well as upfront payments for Molecular Partners, in exchange for all rights being granted to Amgen. As the two companies prepared for a clinical debut in 2019, the compound’s name was adjusted to reflect the joint effort- MP0310/AMG 506.

While the name has changed, the molecule’s potential has remained the same since Amgen first expressed interest. A Phase I clinical trial (NCT04049903) investigating the safety and efficacy of MP0310 in patients with advanced solid tumors is ongoing, with a target enrollment of 58 participants. Interim data for the open-label study was published in 2020. Efficacy was demonstrated as 50% of participants achieved stable disease, and no serious adverse events or events that would require dose-limiting were reported. Immune system and fibroblast activation increased following treatment. Overall, the MP0310 remained localized, targeting the tumor without activity spreading to peripheral tissues.

Primary endpoints include incidence of dose-limiting toxicity events, expansion dosing recommendation and incidence of adverse events. Additional data will be collected from secondary endpoints, which include serum concentration levels of MP0310, serum concentration of anti-MP0310 antibodies, objective response rate, duration of response, disease control rate and various pharmacokinetic analyses related to retention of the drug. Full data is expected in the second half of 2022.

The future for MP0310 under Molecular Partners will include additional clinical studies to determine an optimal dosing schedule. Other therapeutic candidates utilizing the company’s DARPin technology include MP0420, a COVID-19 antiviral currently in Phase I, II and II/III studies to demonstrate efficacy in an ambulatory setting. Molecular Partners’ MP0317 is the focus of a Phase I open-label clinical study (NCT05098405) that is currently recruiting in the Netherlands and France. MP0317 targets fibroblast activating protein (FAP) and CD40 to provide additional options to patients diagnosed with tumors that overly express FAP, and for which no treatment options remain.