Agenus Presents Additional Clinical Responses and Novel Biomarker Data at SITC2020

• AGEN1181: New clinical responses and intratumoral Treg depletion
• AGEN1777 (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 benefit 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) shows additional clinical responses in tumors which are “biomarker unlikely” to respond; first–ever clinical data on intratumoral 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 tumor 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
• No 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 the Poster Hall beginning November 9^th at 8am. In addition, the presenting authors will be available for live discussions 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 (NCT03860272)
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
Caroline.Bafundo@agenusbio.com