On December 11, 2023 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported that it has triggered the second development milestone payment under its global licensing agreement with Bristol Myers Squibb for BMS-986442, an Fc-enhanced bispecific TIGIT antibody (Press release, Agenus, DEC 11, 2023, View Source [SID1234638470]). Agenus will receive a $25 million cash payment from Bristol Myers Squibb with the dosing of the first patient in the phase 2 dose expansion portion of the ongoing CA115-001 clinical trial of BMS-986442.
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BMS-986442 (also known as AGEN1777) is a dual TIGIT and CD96 antagonist with an enhanced Fc region to improve tumor-reactive T cell responses. Bristol Myers Squibb licensed BMS-986442 from Agenus in 2021. The phase 1 dose escalation study in solid tumors is complete and the phase 2 portion of the dose expansion combination study evaluating the combination of BMS-986442 with nivolumab +/- chemotherapy is ongoing.
"The start of the phase 2 portion of the dose expansion study marks an exciting milestone for this differentiated anti-TIGIT program and an important step in potentially delivering a meaningful new option for cancer patients," said Chief Executive Officer, Garo Armen, Ph.D. "Similar to our lead program botensilimab, we engineered this bispecific TIGIT antibody with an Fc-enhanced design, which we believe to be a pivotal feature for boosting clinical activity. We look forward to the future development of this program together with our partner Bristol Myers Squibb, as we remain committed to delivering innovation in cancer research."
The agreement also includes up to $1.32 billion in additional development, regulatory and commercial milestones plus tiered double-digit to mid-teens royalties. Bristol Myers Squibb is solely responsible for the development and any subsequent commercialization of BMS-986442 and its related products worldwide. Agenus retains options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, to co-fund global development for increased U.S. royalties, and to co-promote BMS-986442 in the U.S. upon commercialization.