Agenus Inc. announced the U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for this therapy. AGEN1777 is an Fc-enhanced antibody in late preclinical development designed to target major inhibitory receptors expressed on T and NK cells to improve anti-tumor activity. Bristol Myers Squibb intends to advance the research and development of AGEN1777 in immuno-oncology for high priority tumor indications including non-small cell lung cancer. Phase 1 dosing for AGEN1777 is expected to begin during the third quarter of 2021. This dose escalation study is designed to evaluate the safety, tolerability, and preliminary clinical activity of AGEN1777 as a single agent and in combination with a PD-1 inhibitor in patients with advanced solid tumors. Under the terms of the agreement with Bristol Myers Squibb, Agenus receives a $200 million upfront payment in connection with the closing. The agreement also includes up to $1.36 billion in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales. Bristol Myers Squibb will become solely responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide. Agenus will retain options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, and also, upon commercialization, to co-promote AGEN1777 in the US. AGEN1777 is a potentially first-in-class bispecific anti-TIGIT antibody engineered with an enhanced Fc region for high binding affinity and improved T and NK cell activation.