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FDA Grants Agenus Type B End-of-Phase 2 Meeting to Discuss BOT/BAL Therapy for Relapsed or Refractory Metastatic Colorectal Cancer

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Agenus has announced a significant milestone: an FDA Type B End-of-Phase 2 meeting set for July to discuss the botensilimab and balstilimab (BOT/BAL) combination therapy for relapsed/refractory metastatic colorectal cancer (r/r MSS mCRC).

This meeting aims to expedite the development of BOT/BAL and potentially support a future Biologics License Application (BLA) under the FDA’s accelerated approval pathway. The therapy previously received fast track designation in April 2023.

Phase 1 and 2 data from BOT/BAL studies provide insights into its potential efficacy for this challenging cancer type. These findings will be presented at a major medical conference later this year.

Beyond colorectal cancer, Agenus is exploring BOT/BAL for other cancer indications and plans to present further data at upcoming medical conferences.

Positive
  • Agenus received FDA Type B End-of-Phase 2 meeting for BOT/BAL therapy in July.
  • BOT/BAL combination therapy received fast track designation in April 2023.
  • Phase 1 and Phase 2 data provide promising insights for BOT/BAL in r/r MSS mCRC.
  • Potential future BLA submission under FDA's accelerated approval pathway.
  • BOT/BAL shows clinical responses in nine metastatic, late-line cancers.
Negative
  • No immediate approval for BOT/BAL therapy as it is still in the early stages of FDA discussions.
  • Potential delays in BLA submission and approval depending on FDA feedback.
  • No clinical data from Phase 3 trials available yet.

The upcoming Type B End-of-Phase 2 meeting with the FDA for Agenus' botensilimab and balstilimab (BOT/BAL) therapy marks a critical juncture in the development of this novel cancer treatment. This therapy is specifically aimed at patients with relapsed/refractory metastatic colorectal cancer (r/r MSS mCRC), one of the more challenging forms of cancer to treat. Presenting Phase 2 data to a major medical conference and securing fast track designation from the FDA elevates the therapy's profile significantly.

Botensilimab is a human Fc-enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. The combination with balstilimab, an investigational PD-1 antibody, is intended to extend immunotherapy benefits to 'cold' tumors which typically do not respond well to existing therapies. This innovative approach could be a game-changer for a subset of colorectal cancer patients, addressing an unmet medical need.

However, it's essential to proceed cautiously. The transition from Phase 2 to Phase 3 involves considerable risk and capital. Investors should monitor the Phase 3 study design closely, as well as any feedback from the FDA, to understand the probability of successful approval under the accelerated pathway.

From a financial perspective, the Type B EOP2 meeting with the FDA is a positive signal for Agenus. Fast track designation and the upcoming Phase 3 study create the potential for accelerated approval, which could translate into quicker revenue generation if successful. This is encouraging for investors, as it may shorten the time to market and broaden the treatment landscape for colorectal cancer.

One aspect to consider is the financial burden associated with advancing to Phase 3 trials and preparing for a Biologics License Application (BLA). Such processes are costly and resource-intensive. Agenus will likely need to secure additional funding or partnerships to support these endeavors. Investors should keep an eye on the company's financial health, funding mechanisms and any potential dilution of shares that might arise.

Additionally, the commitment to explore BOT/BAL in other cancer indications presents future growth opportunities beyond colorectal cancer. This diversification can hedge against the single-therapy risk and bolster long-term investor confidence.

The announcement of a Type B End-of-Phase 2 meeting with the FDA indicates that Agenus is making strategic moves to bring its BOT/BAL therapy to market swiftly. The significance of this event is underscored by the fast track designation granted by the FDA, which aims to expedite the review process for promising treatments that address unmet medical needs.

The colorectal cancer market, particularly for non-MSI-high or dMMR metastatic cases, is underserved due to the complexity and limited efficacy of current treatments. BOT/BAL's unique mechanism of action, which includes priming and activating T cells as well as inducing long-term memory responses, gives it a competitive edge in this landscape.

With colorectal cancer being one of the fastest-growing cancer types in the U.S., especially among younger adults, there is a substantial market opportunity for effective therapies. If BOT/BAL can demonstrate significant efficacy and safety in Phase 3 trials, Agenus could capture a significant share of this growing market, positioning it favorably for future growth.

However, market penetration will depend on several factors, including the pricing strategy, insurance coverage and adoption rate among oncologists. Investors should be aware of these dynamics as they could impact the therapy's commercial success.

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced it will conduct a Type B End-of-Phase 2 (EOP2) meeting in July with the U.S. Food and Drug Administration (FDA) to discuss the botensilimab plus balstilimab (BOT/BAL) combination therapy studies in patients with relapsed/refractory metastatic colorectal cancer that is not MSI-high or dMMR (r/r MSS mCRC), as well as the critical elements of the program to support a future biologics license application (BLA) submission.

The meeting is scheduled as part of Agenus’ ongoing efforts to expedite the development of this promising therapeutic option in CRC, considered to be one of the most challenging types of cancer due to its high incidence and mortality rates. It is also one of the fastest-growing cancer types in the U.S., particularly noted for its increasing prevalence among younger adults. Agenus aims to collaborate closely with the FDA to outline the path forward, including the Phase 3 study design and other elements needed to support a BLA filing under the FDA’s accelerated approval pathway. The FDA granted BOT/BAL fast track designation in April 2023.

“Our upcoming End of Phase 2 meeting with the FDA represents a significant milestone in the ongoing development of BOT/BAL for patients diagnosed with metastatic MSS CRC who do not have active liver metastases,” stated Steven O’Day, M.D., Chief Medical Officer of Agenus. “The results from our Phase 1 and Phase 2 studies contribute valuable insights into the potential of this therapy for managing a specific and challenging subgroup of colorectal cancer. We remain dedicated to further exploring innovative immunotherapeutic strategies.”

The Phase 2 data will be submitted to a major medical conference later this year. In addition to advancing BOT/BAL in colorectal cancer, Agenus remains committed to exploring the potential of this combination therapy in other cancer indications and is preparing to present further data at upcoming medical conferences.

About Botensilimab

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

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 a its botensilimab and balstilimab programs, expected regulatory timelines and filings, 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 and available on our website at www.agenusbio.com. 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.

Investor

917-362-1370

investor@agenusbio.com

Media

612-839-6748

communications@agenusbio.com

Source: Agenus Inc.

FAQ

What is the significance of Agenus's FDA Type B End-of-Phase 2 meeting?

The meeting aims to expedite the development of BOT/BAL therapy for relapsed/refractory metastatic colorectal cancer and potentially support a future Biologics License Application.

What is the BOT/BAL therapy?

BOT/BAL is a combination of botensilimab and balstilimab being developed for relapsed/refractory metastatic colorectal cancer.

When is Agenus's FDA Type B End-of-Phase 2 meeting scheduled?

The meeting is scheduled for July.

What designation did BOT/BAL receive from the FDA in April 2023?

BOT/BAL received fast track designation.

What are the goals of Agenus's upcoming FDA meeting?

The goals include discussing Phase 3 study design and elements needed to support a BLA filing under the FDA’s accelerated approval pathway.

What is the potential impact of BOT/BAL therapy?

BOT/BAL aims to provide a new therapeutic option for relapsed/refractory metastatic colorectal cancer, particularly for patients without MSI-high or dMMR.

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