Linnaeus Announces Clinical Trial Collaboration Agreement with Merck

Linnaeus Therapeutics has entered into a clinical collaboration agreement with Merck to evaluate the combination of its lead investigational product candidate LNS8801, and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with selected advanced solid tumors.

LNS8801 is a first-in-class, orally bioavailable small molecule that is a highly specific and potent agonist of the G-protein estrogen receptor (GPER). GPER is widely expressed on cancers.  Agonizing GPER both stops cancers from proliferating and makes them more visible to the immune system.

Under the terms of the agreement, Linnaeus will conduct a Phase 2 study in patients who had previously responded to anti-PD-1 therapy and have since progressed.

"We are pleased to collaborate with Merck, the established leader in cancer immunotherapy, as we advance LNS8801 into Phase 2 clinical trials," said Patrick Mooney, MD, Chief Executive Officer of Linnaeus. "Based on what we have seen in animal models and in our Phase 1, dose-escalation study of LNS8801 in patients with advanced cancers, we are optimistic that the combination of LNS8801 and KEYTRUDA could provide meaningful benefit to this patient population."

LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies and immunotherapies. LNS8801 is currently in a Phase I/II clinical trial in advanced cancer patients at six comprehensive cancer centers in the United States.