TetraLogic, Merck Enter Oncology Clinical Pact

TetraLogic Pharmaceuticals Corp. and Merck have entered an oncology clinical study collaboration to evaluate the safety and efficacy of birinapant, TetraLogic’s SMAC-mimetic, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. The Phase I study is expected to begin in late 2015.

KEYTRUDA and birinapant target different elements of cancer’s block against the immune system. The collaboration is based on preclinical data that suggest SMAC-mimetics have the potential to enhance existing immuno-oncology agents, such as KEYTRUDA.
The companies will collaborate on an initial Phase I dose-escalation study of birinapant in combination with KEYTRUDA in patients with relapsed or refractory solid tumors. TetraLogic will fund the study and Merck will provide KEYTRUDA. The companies have formed a Joint Development Committee to oversee the conduct of the study. Results from the study will be used to determine further clinical development of the combination.

 “We are very excited to work with Merck to evaluate birinapant in combination with KEYTRUDA,” said J. Kevin Buchi, president and chief executive officer of TetraLogic. “Both molecules are designed to help the body’s immune system better attack cancer cells, and we think the combination could be very promising.”

“We are establishing a broad base of clinical evidence with our anti-PD-1 therapy, KEYTRUDA, as monotherapy across different types of cancer,” said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. “We believe there is great potential to advance our clinical program and the field of immuno-oncology research through strategic collaborations and synergistic combinations, such as with KEYTRUDA and birinapant.”