Gossamer bio announces clinical trial collaboration agreement with merck to evaluate gb1275 in combination with keytruda® (pembrolizumab) in selected advanced solid tumors

Gossamer bio, inc. announced that it has entered into a clinical collaboration agreement with merck (known as msd outside the us and canada) to evaluate the combination of gossamer’s investigational product candidate gb1275, the first-in-class oral modulator of cd11b, and merck’s anti-pd-1 therapy, keytruda® (pembrolizumab) in patients with selected advanced solid tumors. under the terms of the agreement, gossamer will conduct a phase 1/2 study, keynote-a36, in advanced solid tumors, with the phase 1 consisting of dose escalation of three gb1275 regimens including one with keytruda. additionally, the phase 2 consists of expansion cohorts evaluating gb1275 in combination with keytruda or chemotherapy. gossamer owns worldwide commercial rights to gb1275. gb1275 is an oral modulator of cd11b, a receptor broadly expressed on immunosuppressive myeloid cells found within the tumor microenvironment (tme). in preclinical studies, gb1275 has been shown to reduce the recruitment of these cells into the tme, while also converting the cells within the tme from an immunosuppressive to an active state. the fda has granted gb1275 orphan drug designation for the treatment of pancreatic cancer. the keynote-a36 phase 1/2 trial is underway, enrolling patients at a number of centers of excellence in the united states and united kingdom for the treatment of selected solid tumor types, including pancreatic, gastric, esophageal, colorectal, prostate and triple negative breast. the phase 1 portion of the study consists of dose escalation of gb1275 monotherapy. subsequently, after clearing several monotherapy dose levels, dose escalation combinations will be initiated with keytruda or chemotherapy. the primary endpoints of the dose escalation phase of the trial are to evaluate the safety, tolerability, and the pharmacokinetics /pharmacodynamics of all three regimens. biomarkers of immunohistochemistry and other immune monitoring methodologies will also be evaluated. gossamer expects to report initial data from the phase 1 portion of the study in the second half of 2020. an abstract detailing the scientific background for the trial and the study design was presented at the 34th annual meeting of the society for immunotherapy of cancer.
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