Date: 2015-04-20
Type of information: Clinical research agreement
Compound: Keytruda® (pembrolizumab) and birinapant
Company: Merck&Co (USA - NJ) TetraLogic Pharmaceuticals (USA - PA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/SMAC inhibitor. Keytruda®(pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda® releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Birinapant (TL32711) is a synthetic small molecule and peptidomimetic of second mitochondrial-derived activator of caspases (SMAC) and inhibitor of IAP (Inhibitor of Apoptosis Protein) family proteins, with potential antineoplastic activity. As a SMAC mimetic and IAP antagonist, birinapant binds to and inhibits the activity of IAPs, such as X chromosome-linked IAP (XIAP) and cellular IAPs 1 and 2. Since IAPs shield cancer cells from the apoptosis process, this agent may restore and promote the induction of apoptosis through apoptotic signaling pathways in cancer cells. Birinapant has been studied in over 350 patients, and is currently in Phase 1 and Phase 2 trials for Myelodysplastic Syndrome (MDS), Ovarian Cancer and Hepatitis B.
Disease: relapsed or refractory solid tumors
Details: * On April 20, 2015, TetraLogic Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, and Merck&Co announced 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.The proposed collaboration is based on preclinical data that suggest SMAC-mimetics have the potential to enhance existing immuno-oncology agents, such as Keytruda®. 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.
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