TetraLogic Pharmaceuticals Corporation and Merck have announced that they have entered into an oncology clinical study collaboration. The companies will collaborate on a Phase 1 study 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 study is expected to begin in late 2015.
KEYTRUDA and birinapant target different elements of cancer's block against the immune system. TetraLogic's birinapant (TL32711) is a potent, bivalent SMAC-mimetic that binds with differential affinity to multiple members of the IAP family in order to re-establish the immune system's ability to kill abnormal cells via an extracellular TNF signal.
Merck's KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PDL1 and PD-L2. The proposed collaboration is based on preclinical data that suggest SMAC-mimetics have the potential to enhance existing immuno-oncology agents, such as KEYTRUDA.
"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 immunooncology research through strategic collaborations and synergistic combinations, such as with KEYTRUDA and birinapant."
Under the terms of the agreement, TetraLogic and Merck, through subsidiaries, will collaborate on an initial Phase 1 dose escalation study of birinapant in combination with KEYTRUDA in patients with relapsed or refractory solid tumors.
TetraLogic will sponsor and fund the study and Merck will provide KEYTRUDA. The companies have formed a Joint Development Committee to collaboratively oversee the conduct of the study. Results from the study will be used to determine the path for further clinical development of the combination.