Agenus Launches Phase 2 Trial Expansion in Colon Cancer for AGEN1181 in Combination with Balstilimab

Rhea-AI Summary

Agenus Inc. (NASDAQ: AGEN) has expanded its Phase 2 trial for AGEN1181 in colorectal cancer following a promising clinical response. A significant tumor reduction of 27% was observed in a patient, alongside disease stabilization in 19 out of 41 treated patients. The trial also reported four clinical responses and the potential to treat tumors traditionally unresponsive to immune therapies. The company aims to broaden the patient population benefiting from cancer immunotherapies through innovative combination approaches.

Positive

• Phase 2 trial expansion based on 27% tumor reduction in colorectal cancer.
• Four clinical responses observed with AGEN1181 +/- balstilimab.
• Disease stabilization achieved in 19 out of 41 patients treated.

Negative

• None.

New objective response in colon cancer triggers trial expansion

LEXINGTON, Mass., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad pipeline which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the expansion of a Phase 2 trial into colon cancer based on a new objective clinical response in a colorectal cancer patient in addition to a significant tumor reduction of 27% and biomarker reduction observed in a patient with MSS colon cancer.

With this recent response in colon cancer, AGEN1181 +/- balstilimab (anti-PD-1) has reported 4 clinical responses plus a significant tumor reduction of more than 27% in a fifth patient. In addition, 19 patients have achieved disease stabilization out of 41 patients treated in what was designed as a dose escalation study.

Recently, Agenus also presented on the first-ever report of intratumoral Treg depletion with a CTLA-4 antibody in clinical trials. The summary of responses achieved with AGEN1181 alone or in combination with balstilimab are as follows:

• CR in PD-L1(-) MSS endometrial cancer patient (1181 monotherapy)
• CR in PD-L1(-) MSS endometrial cancer patient (1181 + bali)
• PR in a colorectal 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 with remarkable CEA biomarker reduction from 298 to 2 (1181 + bali)
  

In the phase 1 trial of AGEN1181, clinical benefit and responses have been seen in patients with polymorphism in FcyRIIIA alleles who are not responsive to first-generation CTLA-4 antibodies.

The Phase 2, open-label, multicenter study will focus primarily on colorectal cancer and select solid tumors, such as lung cancer and melanoma.

“These early data are very exciting, particularly in aggressive tumors that have traditionally been unresponsive to immune therapies, like colorectal cancer,” said Dr. Joseph Grossman, expert in gastrointestinal cancers and the Head of Exploratory Medicine at Agenus. “AGEN1181 has potential to not only broaden the population of responders to CPIs, but also to reach tumors traditionally considered “cold” or unresponsive to immune therapies. I am excited to see the potential broadened benefit of our next-generation anti-CTLA-4’s design, particularly its Fc-enhancement, and the validation of Agenus’ incredible R&D capabilities.”

Dr. Joseph Grossman recently joined Agenus as head of exploratory medicine from Harvard Medical School, where he was an instructor in medicine, and Beth Israel Deaconess Medical Center, where he served as an attending physician in GI oncology. He completed his residency and fellowship in hematology oncology at Beth Israel Deaconess Medical Center. He holds a postbaccalaureate certificate in premedical sciences from Columbia University in the City of New York and an MD from Brown Medical School.

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 AGEN1181. 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

 

FAQ

What are the latest results from the AGEN1181 trial for colorectal cancer?

The latest results show a 27% tumor reduction in one patient and disease stabilization in 19 out of 41 patients treated.

What is the focus of the expanded Phase 2 trial for AGEN1181?

The expanded Phase 2 trial will primarily focus on colorectal cancer and select solid tumors, including lung cancer and melanoma.

How many patients achieved clinical responses in the AGEN1181 trial?

Four patients achieved clinical responses, and significant disease stabilization was noted in 19 patients.

What potential does AGEN1181 have in treating cancers?

AGEN1181 has the potential to broaden the population of responders to immune therapies, especially for tumors traditionally considered 'cold' or unresponsive.

When was the press release about AGEN1181's trial results published?

The press release was published on December 1, 2020.