Leap Therapeutics (NASDAQ: LPTX) announced on Monday (July 23) a blockbuster collaboration with Merck KGaA (OTCP: MKGAY) and Pfizer (NYSE: PFE) to evaluate its TRX518 product together with avelumab, which is a human anti-PD-L1 IgG1 monoclonal antibody and chemotherapy.
Leap will conduct a Phase 1/2 clinical trial for advanced solid tumors in patients with relapsed/refractory ovarian, breast and prostate cancers to determine whether or not the drug will shrink those tumors.
Under the collaboration terms, the study will start enrolling patients within the first quarter of 2019.
TRX518 is Leap Therapeutics’ second product candidate and is a novel, humanized anti-GITR (glucocorticoid-induced necrosis factor receptor) monoclonal antibody meant to improve the immune system’s anti-tumor response as an immune checkpoint agonist. The product is currently in two repeat-dose Phase 1 clinical trials for solid tumor malignancies.
“TRX518 has demonstrated encouraging potential with early clinical activity in patients with advanced solid tumors,” Chris Boshoff, M.D., Ph.D., and senior vice president and head of immuno-oncology, early development and translational oncology, at Pfizerglobal product development said in the release. “This collaboration with Leap Therapeutics to evaluate TRX518 in combination with avelumab gives us the opportunity to investigate a potential novel immunotherapy treatment regimen as we pursue our mission of improving outcomes for patients living with hard-to-treat cancers.”
The release also states that the US Food and Drug Administration (FDA) granted accelerated approval to avelumab for treating patients with metastatic Merkel cell carcinoma (MCC) and patients who were previously treated for locally advanced or metastatic urothelial carcinoma (muC).
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody developed by Merck, Pfizer and Eli Lilly and Company (NYSE: LLY) in Canada. Earlier this year the drug’s Phase 3 lung cancer trial failed to meet pre-specified endpoints of improving overall survival for those with PD-L1 tumors.
Now the drug is being evaluated in the JAVELIN clinical development program that entails roughly 30 clinical programs and over 8,600 patients that span more than 15 different types of tumors.
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