Agenus Presents Additional Clinical Responses and Novel Biomarker Data at SITC2020

AGEN1181 : New clinical responses and intratumoral Treg depletion AGEN 1777 ( TIGIT ) is Fc enhanced for optimized immune performance & broader benefit AGEN2373 (anti-CD137) : Clinical benefit with no liver toxicity Allogeneic iNKTs : Potent tumor cell killing and tumor microenvironment regulation VISION : Proprietary platform for response prediction and optimal combos Zalifrelimab (anti-CTLA-4) : 1 CR, 2 PRs, and 52% benefit in PD-1 refractory tumors Managing pseudoprogression expands bal/zal b enefit in cervical cancer LEXINGTON, Mass., Nov. 09, 2020 (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 announced presentations on seven novel programs at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) on November 9-14, 2020. “ This year, our strong showing at SITC includes new data and presentations on seven novel programs and platforms, ” said Dr. Jennifer Buell, President and COO of Agenus. “Our focus is to deliver curative cancer treatments with our best-in-class inventions. We believe that our science along with our broad portfolio of immuno-oncology agents give us the ability to match patients to therapies using optimal combinations. At SITC, we will present additional clinical responses with our Fc-enhanced anti-CTLA-4, AGEN1181, advances with our VISION responder prediction platform, and data on four other clinical-stage programs.” Presentation Highlights : AGEN1181 (Fc-enhanced CTLA-4) +/- balstilimab ( Agenus’ anti-PD-1) show s additional clinical responses in tumors which are “biomarker unlikely” to respond; first - ever clinical data on i ntratumor al Treg depletion with a CTLA-4 antibody : CR in PD-L1(-) MSS endometrial cancer patient (1181 monotherapy) CR measured by PET in PD-L1(-) MSS endometrial cancer patient (1181 + bali) PR in PD-L1(-) refractory ovarian cancer patient (rescued with 1181 + bali) – previous stable disease for 66 weeks with 1181 monotherapy Major t umor reduction (27%) in MSS colorectal cancer patient – CEA biomarker declined from 298 to 2 (1181 + bali) Benefit seen in patients with polymorphism in FcyRIIIA alleles who don’t respond to first - generation CTLA-4 antibodies First-ever clinical report of selective depletion of intratumoral Tregs with a CTLA-4 antibody N o complement - mediated toxicities AGEN Fc-enhanced anti-TIGIT antibodies Significant superiority vs other TIGIT antibodies Potential to broaden benefit to patients with low and high affinity FcyIIIA alleles; akin to AGEN1181 Superior NK cell activation, T cell responsiveness, and antigen-specific CD8 T cell memory compared to other clinical-stage TIGIT antibodies AGEN2373 , an anti- CD137 agonist monotherapy , shows clinical benefit without liver toxicity SD in 4 patients with durable disease stabilization in an ovarian cancer patient No liver toxicity in patients dosed up to 1mg/kg AGEN2373 clinical data indicate increased trafficking of CD8 and CD4 T cells, and mature NK cells in the tumor microenvironment; 2373 also promotes robust depletion of intratumoral Tregs AgenT-797 , a clinical - stage allogeneic iNKT cell therapy , demonstrates direct tumor killing, tumor microenvironment conditioning ; lower - cost scalable manufacturing iNKT cells promote direct tumor killing and tumor microenvironment conditioning demonstrated with biomarkers for both Th1 and Th2 activation Efficient and low-cost manufacturing process yielding more than 100 treatments from a single source with process development to yield 1000 treatments iNKTs can also be engineered with CAR technology VISION – AGENUS’ proprietary time - lapse biomarker platform designed to predict responses and define effective combinations Deep in vitro profiling, functional genomics, and Al-based approaches to predict clinical outcomes and identify optimal targets and combinations VISION predicted responses to anti-PD-1 with 87% accuracy in melanoma and 86% accuracy in cervical cancer Identified enhanced cytotoxicity of anti-PD-1 and anti-TIGIT combination Agenus ePosters and corresponding audio will be available for viewing in th e Poster Hall beginning November 9 th at 8 am . In addition, the presenting authors will be available for live discussion s at the following times: Abstract title: AGEN1181, an Fc engineered anti-CTLA-4 antibody, demonstrates clinical activity, alone or in combination with balstilimab (anti-PD-1), and broadens the therapeutic potential of CTLA-4 therapy ( N CT03860272) Abstract number: 398 Presenting author: Dr. Stephen O’Day Live discussion times: 11/12 4:50-5:20pm; 11/14 1:00-1:30pm Abstract title: Single-agent Zalifrelimab (anti-CTLA-4) Shows Clinical Benefit in Rare Tumors - Case Report from Phase 2 Study (NCT03104699) Abstract number: 256 Presenting author: Dr. Cesar Perez Live discussion times: 11/12 4:50-5:20pm; 11/14 1:00-1:30pm Abstract title: AGEN2373 is a CD137 agonist antibody designed to leverage optimal CD137 and FcγR co-targeting to promote antitumor immunologic effects Abstract number: 377 Presenting author: Dr. Claire Galand Live discussion times: 11/11 5:15-5:45; 11/13 4:40-5:10pm Abstract title: Pseudoprogression Patterns: Analysis from 2 Independent Phase-2 Studies with Immunotherapy for Recurrent Cervical Cancer Abstract number: 267 Presenting author: Dr. David O’Malley Live discussion times: 11/11 5:15-5:45pm; 11/13 4:40-5:10pm Abstract title: AgenT-797, a novel allogenic and “off-the shelf” iNKT cell therapy promotes effective tumor killing Abstract number: 164 Presenting author: Dr. Burcu Yigit Live discussion times: 11/12 4:50-5:20; 11/14 1:00-1:30pm Abstract title: Anti-TIGIT antibodies require enhanced FcγR co-engagement for optimal T and NK cell-dependent anti-tumor immunity Abstract number: 253 Presenting author: Rebecca Ward Live discussion times: 11/11 5:15-5:45pm; 11/13 4:40-5:10pm Abstract title: Beyond PD-L1: novel PD-1 biomarkers identified by driving T cell dysfunction in vitro Abstract number: 70 Presenting author: Dr. Simarjot Pabla Live discussion times: 11/12 4:50-5:20pm; 11/14 1:00-1:30pm About Agenus Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of Agenus’ product candidates and the potential capabilities of Agenus’ VISION platform. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contact: Agenus Inc. Caroline Bafundo 212-994-8209 [email protected] View All News Contact Us Agenus Inc. [email protected] Quick Links SEC Filings Information Request Form Investor Email Alerts To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. After submitting your request, you will receive an activation email to the requested email address. You must click the activation link in order to complete your subscription. You can sign up for additional alert options at any time. At Agenus Inc., we promise to treat your data with respect and will not share your information with any third party. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the ‘unsubscribe’ section below. If you experience any issues with this process, please contact us for further assistance. 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