Earnings release
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EXHIBIT 99.1 Agenus Corporate Update and Second Quarter 2021 Financial Report • $ 200M received from BMS for anti - TIGIT bispecific antibody collaboration • ⚫ FDA cleared IND for AGEN1777 clinical enrollment • AGEN1181 rapidly advancing in the clinic ; data to be presented in 2H 2021 • Cell therapy subsidiary MiNK Therapeutics filed confidential S - 1 for planned IPO • FDA accepted balstilimab BLA for Priority Review with December PDUFA date LEXINGTON , Mass . , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) -- Agenus Inc. ( NASDAQ : AGEN ) , an immuno - oncology company with an extensive pipeline of checkpoint antibodies , cell therapies , adjuvants , and vaccines designed to activate immune response to cancers and infections , today provided a corporate update and reported financial results for the second quarter of 2021 . “ In the first half of this year , we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point , ” said Garo Armen , PhD , Chairman and Chief Executive Officer of Agenus . “ In the second half , we will disclose this data at a key cancer conference and be ready with our commercial platform in preparation for a balstilimab launch . " AGEN1181 ( Fc - enhanced anti - CTLA - 4 ) : Clinical data support superior activity in difficult - to - treat cancers • Updated clinical data for AGEN1181 alone and in combination with balstilimab will be presented at an upcoming conference . • Clinical responses seen in patients refractory to approved immunotherapies , including patients with microsatellite stable ( MSS ) tumors and melanoma , endometrial , and ovarian cancer with the low - affinity FcyRIIIA allele . No immune mediated hypophysitis , pneumonitis , or hepatitis ( typically seen with first generation anti - CTLA - 4s ) were reported . • Registrational trials targeted to commence by year - end 2021 with a focus on rapid path to Biologics License Application ( BLA ) submission . MiNK Therapeutics : Allogeneic iNKT cell therapy company advances towards IPO • MiNK Therapeutics ( currently an Agenus company ) filed a confidential S - 1 to support a planned Initial Public Offering ( IPO ) . • Phase 1 trial of AGENT - 797 in hematologic cancers dose cohorts completed with data readouts planned in the second half of 2021 ; Phase 1/2 expansion trials in viral acute respiratory distress syndrome ( ARDS ) are underway . AGEN1777 ( Fc - enhanced anti - TIGIT bispecific ) : Collaboration with BMS provides additional cash resources to advance Agenus ' high value drivers • Global exclusive license with Bristol Myers Squibb for AGEN1777 provides $ 200 million upfront cash . In addition , Agenus to receive up to $ 1.36 billion in development , regulatory , and commercial milestones , and tiered double - digit royalties upon product sales . • FDA cleared Investigational New Drug ( IND ) application ; Phase 1 dosing with AGEN1777 alone and in combination with an anti - PD - 1 in advanced solid tumors planned to begin this quarter . Balstilimab ( anti - PD - 1 ) : BLA accepted for Priority Review by U.S. FDA ; data updates presented at ASCO • Balstilimab BLA accepted for Priority Review by the U.S. Food and Drug Administration ( FDA ) with a Prescription Drug User Fee Act ( PDUFA ) target action date of December 16 , 2021 . • Commercial preparation underway for a highly efficient , targeted launch to provide broad product access to physicians and patients while laying the foundation for future Agenus products . • Clinical data presented at the American Society of Clinical Oncology ( ASCO ) Annual Meeting : 。 Phase 2 data for balstilimab showed a response rate of 20 % in PD - L1 positive tumors , overall response rate of 15 % , and median duration of response of 15.4 months . 。 Balstilimab showed superior tumor killing compared to approved anti - PD - 1s such as pembrolizumab and nivolumab . • Results from a Phase 2 trial of balstilimab plus zalifrelimab combination in recurrent or metastatic cervical cancer to be presented in a Mini Oral Session at the European Society for Medical Oncology ( ESMO ) Congress 2021 on September 19 from 11:35 11:40 am ET . _ Additional programs