Leap Therapeutics, a biotechnology company developing targeted and immuno-oncology therapeutics, announced it has entered into a collaboration agreement with Merck KGaA and Pfizer to evaluate Leap’s GITR agonist, TRX518, in combination with avelumab, a human anti-PD-L1 IgG1 monoclonal antibody, and chemotherapy.
Under the terms of the collaboration, Leap will be conducting a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast, and prostate cancers. The study is expected to begin enrolling patients in the first quarter of 2019.
Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.
Immuno-oncology is a top priority for Merck KGaA and Pfizer Inc. The global strategic alliance between Merck KGaA and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA.
The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.