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Termination of a Material Definitive Agreement

On February 10, 2025 Agenus reported that in January 2015 it has entered into a License, Development, and Commercialization Agreement (the "Agreement") with Incyte Corporation ("Incyte"), under which Incyte licensed exclusive rights to certain immuno-oncology programs, including antibodies targeting GITR, OX40, TIM-3, LAG-3, and additional undisclosed targets (Filing, 8-K, Agenus, FEB 10, 2025, View Source [SID1234650127]).

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Incyte previously terminated the OX40 program (effective October 2023) and the GITR and an undisclosed program (effective May 2024). In July 2024, Incyte announced that it would discontinue development of its LAG-3 and TIM-3 programs. On February 4, 2025, Agenus received formal notice from Incyte electing to terminate the Agreement effective February 4, 2026, in line with its strategic portfolio reprioritization. Upon termination, all rights to LAG-3 and TIM-3 revert to Agenus.

With this termination, Agenus will regain full control of these assets and will evaluate future opportunities for their advancement, including internal development and potential new partnerships.

The foregoing summary of the material terms of the Agreement is qualified in its entirety by the complete terms and conditions of the Agreement, filed with the Securities and Exchange Commission on March 16, 2015, as Exhibit 10.22 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 and the First Amendment to the Agreement filed on May 4, 2017, as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017.

PHC and CCRM Collaborate to Develop Primary T-Cell Expansion Culture Processes to Enhance Efficiency and Improve Cell Quality

On February 10, 2025 PHC Corporation reported to have signed a Master Collaboration Agreement with CCRM to work together on the development of primary T-cell(*1) expansion culture processes that will seek to accelerate the manufacturing of cell and gene therapy (CGT) products (Press release, CCRM, FEB 10, 2025, View Source [SID1234650119]). This joint initiative will integrate "LiCellGrowTM(*2), PHC’s cell expansion system under development, with CCRM’s deep knowledge of regenerative medicine and biomanufacturing to establish new culture processes to improve cell culture efficiency and quality for CGTs.

Primary T-cells are used in process development and manufacturing for CGTs, such as in CAR-T cell therapy.(*3) However, primary T-cells derived directly from patients often exhibit significant variability in growth rates and quality, making it challenging for researchers to ensure stable cell counts and maintain quality throughout the culture process. To address these challenges and improve the quality of cell-based therapeutics, better cell culture processes are needed.

Chikara Takauo, Director of PHC and Head of the Biomedical Division that leads the company’s Life Science business, commented: "We are delighted to begin this joint research and development initiative with CCRM, a leader with 14 years of experience in the commercialization of regenerative medicine and CGT. By combining the technologies and expertise of both of our organizations, we aim to advance the manufacturing processes for cell-based therapeutics and cell culture technologies, contributing to the early practical application of CGT."

PHC has developed proprietary In-Line monitoring technology to track key indicators of cell metabolism in real-time, which can help researchers address issues like cell quality and reproducibility, and establish optimal cell culture methods. This technology enables precise, continuous measurement of glucose uptake and lactate production during cell culture, providing a more precise understanding of changes in cell metabolism over time than is possible to observe using traditional sampling methods. In 2024, PHC launched the live-cell metabolic analyzer "LiCellMoTM(*4)" incorporating this technology in the United States, Canada, Europe and some Asian markets including Japan, China, Singapore and Taiwan.

Building on this technology, the company is also developing "LiCellGrow," a cell expansion system designed to exchange media automatically based on the metabolic state of the cells and to maintain the culture environment in an optimal state. PHC aims to further expand its product lineup to seamlessly support research, process development, and commercial manufacturing of cell-based therapeutics.

"We are excited to collaborate with PHC to unlock new possibilities in cell culture," explained Michael May, President and CEO of CCRM. "Technology development partnerships, like this one, are key to advancing the industry and making CGT more cost effective, and therefore more accessible to patients around the world."

The joint research with CCRM will allow PHC to analyze culture conditions using "LiCellGrow" to establish optimal culture processes for primary T-cells. The collaboration will seek to accelerate LiCellGrow’s development, contributing to improved cell quality, enhanced manufacturing efficiency, and cost reduction in the production of cell-based therapeutics.

CARsgen’s First Enrolled Subject in the THANK-u Plus™ Platform-Based Allogeneic CAR-T Trial Achieves sCR at Week 4

On February 9, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the first subject treated with an allogeneic BCMA CAR-T therapy developed on the THANK-u Plus platform, has achieved stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment (Press release, Carsgen Therapeutics, FEB 9, 2025, View Source [SID1234650118]).

The patient, diagnosed with relapsed/refractory multiple myeloma, IgA-λ type (R-ISS Stage II), had previously undergone three lines of combination therapy along with autologous hematopoietic stem cell transplantation. After disease progression following the most recent treatment, the patient was enrolled in the clinical trial. Following infusion of CAR‑T cells at the lowest dose level according to the clinical protocol, the patient experienced Grade 1 cytokine release syndrome (CRS), which was effectively managed with antipyretics and tocilizumab, and the patient did not show immune effector cell-associated neurotoxicity syndrome (ICANS) or other CAR-T-related immune adverse events, demonstrating an overall favorable safety profile.

This CAR-T therapy is developed for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory plasma cell leukemia (R/R PCL). Additional data updates are anticipated in the second half of this year.

"Developed in-house, the THANK-u Plus platform is an innovative allogeneic CAR-T technology designed to overcome the accessibility challenges in CAR-T therapy. The expansion of CAR-T cells and the preliminary positive efficacy observed in the first subject further reinforce our confidence in the future of allogeneic CAR-T products development. We extend our sincere gratitude to the investigators for their invaluable collaboration and to the patients for participating in this trial—efforts that accelerate our mission to address unmet medical needs," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

About THANK-u Plus

CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR. Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies.

Non-consolidated Financial Results for the Fiscal Year Ended December 31, 2024

On February 7, 2025 Oncolys BioPharma reported Non-consolidated Financial Results for the Fiscal Year Ended December 31, 2024 (Press release, Oncolys BioPharma, FEB 7, 2025, View Source [SID1234654152]).

Third Quarter Financial Results for Fiscal Year Ending March 31, 2025

On February 7, 2025 Eisai reported its third Quarter Financial Results for Fiscal Year Ending March 31, 2025 (Presentation, Eisai, FEB 7, 2025, View Source [SID1234652323]).