Agenus Presents Data on AGEN1571 (anti-ILT2) at AACR and Announces IND Clearance

Rhea-AI Summary

Agenus Inc. (Nasdaq: AGEN) announced preclinical data presentation of AGEN1571, a novel anti-ILT2 antibody, at the AACR Annual Meeting on April 8-12, 2022. The data highlight robust adaptive and innate immune responses, showing AGEN1571's superior performance compared to existing clinical-stage competitors. Key findings include a ~10-fold higher binding affinity and complete blockade of ILT2-ligand interactions. The company has cleared its Investigational New Drug (IND) application, paving the way for upcoming clinical trials, further enhancing its immuno-oncology pipeline.

Positive

• First data presentation of AGEN1571 shows strong immune responses.
• IND application cleared by the FDA; clinical trial to commence.
• Preclinical data indicate superior performance to clinical-stage competitors.

Negative

• None.

• First data presentation on AGEN1571 shows strong adaptive and innate immune responses
  
• Preclinical data indicate superior performance to the only clinical-stage competitor
• Monotherapy activity and broad combination potential
• Investigational New Drug (IND) application cleared; clinical trial to commence

LEXINGTON, Mass., April 08, 2022 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, today announced the first presentation of preclinical data from AGEN1571 – a novel anti-ILT2 antibody designed to modulate tumor-associated macrophages, T, NK and NKT cells. These data are being presented at the American Association for Cancer Research (AACR) Annual Meeting being held April 8-12 in New Orleans, LA.

“The ILT receptor family represents a key suppressor of anti-tumor immunity that contributes to resistance to CTLA-4 and PD-1 directed therapies.” said Steven O’Day, MD, Chief Medical Officer of Agenus. “Blocking this receptor family offers the potential to overcome this resistance. This approach is validated by the durable clinical responses achieved in PD-1 resistant cancers with an ILT4 antagonist discovered by Agenus and licensed to Merck. AGEN1571 represents our first fully-owned clinical stage myeloid targeting agent.”

Presentation highlights:

• ILT2 offers a greater potential to overcome resistance to approved immunotherapies compared to ILT4. It provides a more prominent and broader expression profile across immune cell types in the tumor microenvironment.
• AGEN1571 demonstrates superior functional activity compared to the clinical-stage competitor with:
  • ~10-fold higher binding affinity to all isoforms of ILT2, enabling superior binding to cells expressing low levels of ILT2
  • Complete blockade of ILT2-ligand interactions for more effective immune activation and anti-tumor therapeutic potential
  • Enhanced activation of T, NK, and NKT cells for improved tumor-killing
  • Superior ability to switch myeloid cells to a pro-inflammatory state, which further boosts T and NK cell immunity
  • Higher potency in boosting endogenous anti-tumor immunity to synergize with the patient’s anti-tumor antibodies or targeted therapies
• Combinations with botensilimab (Fc-enhanced CTLA-4) and other immuno-oncology agents lead to stronger immune cell activation
• IND application cleared by the FDA; clinical trial to commence
  

Presentation Details:
Abstract Title: AGEN1571 is a novel high-affinity ILT2 antagonist antibody that promotes adaptive and innate immune responses
Abstract Number: 2906 / 21
Session: Therapeutic Antibodies 2
Date / Time: April 12, 2022, 9:00 AM - 12:30 PM
Presenting Author: Olga Udartseva, PhD

The poster presentation can be accessed in the investor section of the Agenus website at https://investor.agenusbio.com/events-and-presentations.

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 subsidiary MiNK Therapeutics), adjuvants, 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 relating to the use of therapeutic candidate AGEN1571, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile (including the absence of specific toxicities) of the therapeutic candidates, both alone and in combination with each other and/or other agents (e.g., botensilimab in combination with AGEN1571); and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. 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.
investor@agenusbio.com

Agenus Media Relations
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com

FAQ

What are the highlights from the AGEN1571 presentation at AACR 2022?

The presentation showcased strong immune responses from AGEN1571, superior binding affinity, and successful IND application clearance for clinical trials.

What is AGEN1571 and its significance for Agenus?

AGEN1571 is a novel anti-ILT2 antibody aimed at enhancing immune responses against tumors, representing a key advancement in Agenus's pipeline.

When will clinical trials for AGEN1571 begin?

Clinical trials for AGEN1571 will commence following the clearance of its IND application by the FDA.

How does AGEN1571 compare to other immunotherapy agents?

AGEN1571 demonstrates superior functional activity and binding affinity compared to its clinical-stage competitors, offering potential advantages in treating resistant cancers.

What is the binding affinity of AGEN1571 compared to competitors?

AGEN1571 has approximately 10-fold higher binding affinity to all isoforms of ILT2, enhancing its efficacy in immune activation.