Agenus Prioritizes Resources to Accelerate Registration and Commercialization of BOT/BAL Program in Multiple Cancers

On August 23, 2023 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a pioneer in immuno-oncology, reported a strategic initiative to prioritize and focus resources to accelerate the development, registration, and commercialization of its flagship program botensilimab/balstilimab (BOT/BAL) (Press release, Agenus, AUG 23, 2023, View Source [SID1234634659]). Under this new plan, Agenus will temporarily postpone all preclinical and clinical programs not related to BOT/BAL. The plan will result in a workforce reduction of approximately 25% and deliver approximately $40 million in savings by the end of 2023.

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The plan will reduce operating expenses across Agenus’ global organization by concentrating its quality, manufacturing, clinical, regulatory, and research & development resources on the BOT/BAL program and drive commercial readiness.

"Now is the pivotal moment to concentrate our efforts on the BOT/BAL program. The observed clinical benefit in solid tumors underscores the program’s game-changing potential, and our rapid progress towards a first filing in 2024 highlights the necessity for prioritization in every aspect of our operations," said Chairman and Chief Executive Officer, Garo Armen, Ph.D. "By zeroing in on BOT/BAL, we expect to expedite regulatory approval and availability for healthcare providers and patients in need. Our decision to streamline operations reflects our commitment to the success of these programs while optimizing shareholder value."

"We deeply value the contributions of our employees and regret the necessity of these difficult decisions," Armen continued. "We are thankful for their dedication and hard work, and we are committed to providing support to those affected during this transition."

Agenus remains dedicated to its deep pipeline of immuno-oncology agents and plans to reactivate these programs in the future. Agenus’ partner-funded programs will not be affected by these measures.

About Botensilimab

Botensilimab, an investigational multifunctional CTLA-4 antibody, is designed to extend immunotherapy benefits to "cold" tumors, which have not historically responded to standard of care or other investigational therapies. Besides binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and activates T cells, thereby enhancing immune responses. Approximately 600 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ 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.

BioCryst to Present at Upcoming Investor Conferences

On August 23, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the 2023 Wells Fargo Healthcare Conference on Wednesday, September 6th in Boston at 3:00 p.m. ET and the H.C. Wainwright 25th Annual Global Investment Conference on Wednesday, September 13th in New York at 12:30 p.m. ET (Press release, BioCryst Pharmaceuticals, AUG 23, 2023, https://ir.biocryst.com/news-releases/news-release-details/biocryst-present-upcoming-investor-conferences-16 [SID1234634658]).

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Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

Medigene Expands Intellectual Property Rights for its Costimulatory Switch Proteins to Additional Immune Cell Types

On August 23, 2023 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported the expansion of the IP license for its PD1-41BB and CD40L-CD28 costimulatory switch proteins, enabling their application to additional cell types and for use in Chimeric Antigen Receptor T cell (CAR-T) therapies (patent number WO2017/162797A1) (Press release, MediGene, AUG 23, 2023, View Source [SID1234634656]). Medigene’s PD1-41BB and CD40L-CD28 costimulatory switch protein technologies were developed by its partner Helmholtz Munich and are exclusively licensed to Medigene.

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With the expansion of the IP license to include various cell types beyond T cell receptor engineered T cells (TCR-T), Medigene significantly enhances the potential use of both costimulatory switch proteins, which are currently combined with the Company’s specific, sensitive and safe T cell receptors (TCRs), across various cell types beyond T cells. This provides an opportunity to leverage the advantages of other immune cells and enhance the tumor cell killing activity, proliferation and persistence of its TCR-based therapies.

In addition, this IP license expansion enables Medigene to potentially enhance the efficacy of CAR-T therapies in patients who relapse and do not respond adequately to earlier lines of therapy due to the upregulation of PD-L1 in certain cancers.

"We are very pleased to continue our excellent collaboration with Helmholtz Munich and expand our IP license, enabling us to extend the anti-tumor enhancements of our PD1-41BB and CD40L-CD28 costimulatory switch proteins, in additional cell types beyond TCR-T therapies," said Dr. Selwyn Ho, Chief Executive Officer at Medigene. "Further, the expansion of this IP license fits well with our mid to long term strategy of focusing on the treatment of solid tumors. We also aim to selectively partner this technology with companies with demonstrated CAR-T expertise to further develop this novel therapeutic approach. This may open up opportunities for new treatment modalities that could help address current unmet needs in difficult-to-treat malignancies."

Gilead Sciences To Present At Upcoming Investor Conferences

On August 23, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 23, 2023, View Source [SID1234634655]):

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Wells Fargo Healthcare Conference Wednesday, September 6 at 11:00 am ET

Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 12 at 11:30 am ET

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

Regeneron Announces Investor Conference Presentations

On August 23, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, AUG 23, 2023, View Source [SID1234634652]):

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• 2023 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 6, 2023

• Morgan Stanley 21st Annual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 11, 2023

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.