On June 24, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612) (Press release, BriaCell Therapeutics, JUN 24, 2025, View Source [SID1234654343]).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date. Bria Cell’s pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in this patient population.

"The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell’s regimen," commented Dr. William V. Williams, BriaCell’s President & CEO. "This latest positive review further strengthens our confidence in Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer."

On June 24, 2025 Vector BioMed, a purpose-driven contract vector development and manufacturing organization (CVDMO) focused on advancing access to cell and gene therapies, reported a strategic partnership with Muni Seva Ashram’s Kailash Cancer Hospital and Research Center (KCHRC) in Gujarat, India (Press release, Kailash Cancer Hospital and Research Center, JUN 24, 2025, View Source [SID1234654101]). This collaboration positions Vector BioMed as the preferred and exclusive CVDMO partner for KCHRC’s cell therapy program, helping expand affordable CAR-T cancer treatment to underserved populations.

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The partnership began in June 2024 after more than a year of due diligence, site visits, and technical evaluations led by KCHRC’s leadership, including Dr. Vikram Patel. The hospital is expected to begin treating its first patients with autologous CAR-T cell therapy in Q1 2026, making it the first site in Gujarat and one of the first in India to deliver advanced treatments outside of a major metropolitan area. Vector BioMed supplies rapid CAR-T formats of prebuilt CARs and validated processes, including a cell manufacturing process ready anti-CD19 CAR-T solution and other IND-ready product options for the production of autologous CAR-T therapies. Constructed to streamline development for hospitals and researchers, this introduces speed, consistency, and a dramatic improvement to the global standard of care for cancer treatment.

Located in rural Gujarat, KCHRC serves over 70,000 outpatients annually, offering reduced (donor supported)- or no-cost care to more than 60% of its patients. The hospital is part of Muni Seva Ashram, a nonprofit institution founded to provide equitable healthcare to India’s most vulnerable communities. With 400 beds, 10 operating rooms, three linear accelerators, and growing GMP capabilities, KCHRC is quickly becoming a regional hub for cutting-edge therapeutics.

"We are pleased to collaborate with Muni Seva Ashram and be a part of bringing financially feasible treatments to patients who never imagined having access," said Dr. Boro Dropulić, CEO of Vector BioMed. "Through this partnership, we’re delivering one of the world’s most advanced cancer therapies to communities that have long been excluded from cutting-edge care. It’s a powerful step toward making world-class care truly universal."

Vector BioMed is supporting the rollout with its LENTIVERSE system, a true platform solution designed for flexibility, affordability, and scalability—especially for low- and middle-income countries (LMICs). The platform technology allows for the treatment of one patient per day, isn’t locked into expensive process technologies, and significantly reduces costs compared to other proprietary systems, making it ideal for nonprofit and resource-limited hospitals like KCHRC.

"This collaboration brings us closer to our goal of providing world-class cancer treatment to every patient who walks through our doors, regardless of their ability to pay," said Dr. Vikram Patel, Chair of Muni Seva Ashram. "Vector BioMed’s knowledge and excellence in vector manufacturing and clinical support has strongly impacted our cell therapy efforts – and will soon greatly impact the lives of our patients."

The partnership is being highlighted in an upcoming live global webinar hosted by the Cell & Gene community (Life Science Connect) titled "Fulfilling the Promise of Advanced Therapies and a Noble Cause," on July 24, 2025 at 11:00am ET / 8:00am PT / 8:30pm IST. The session will explore how advanced therapies can be made accessible in low-resource settings through mission-driven models.

On June 24, 2025 Xcell Biosciences (Xcellbio), a San Francisco-based instrumentation company focused on cell and gene therapy applications, reported a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, to advance research in regulatory T cells (Tregs) and tumor-infiltrating lymphocytes (TILs) (Press release, Xcell Biosciences, JUN 24, 2025, View Source [SID1234654100]). While significant progress has been made in the cell therapy space leveraging Chimeric Antigen Receptor T (CAR T) cells, this collaboration aims to advance Treg and TIL cell therapies that specialize in combating autoimmune and solid tumor diseases. With solid tumors representing approximately 90 percent of adult cancers and instances of autoimmune diseases on the rise worldwide, this collaboration looks to target a crucial area for improving global health.

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Leveraging the strengths of both companies, the joint research will focus on developing new methodologies to enhance the efficacy of Tregs and TILs in therapeutic applications. The collaboration also seeks to streamline workflows while improving scalability and reproducibility in cell therapy manufacturing to help make these critical treatments more accessible to patients.

"We are thrilled to collaborate with Thermo Fisher Scientific on groundbreaking research opportunities. By leveraging our AVATAR cell therapy manufacturing platform, we aim to push the boundaries of what is possible in cell and gene therapy. This partnership will enable us to develop more effective treatments for patients in need," said Shannon Eaker, chief technology officer at Xcell Biosciences.

Thermo Fisher has supported the majority of the approved cell therapies in the market by providing critical tools and materials as well as helping to automate and accelerate manufacturing.

"Xcellbio’s interest in utilizing our Gibco CTS Detachable Dynabeads platform within Thermo Fisher Scientific’s modular, closed and automated cell therapy manufacturing workflow is a testament to the strength of our technologies," said Andy Campbell, senior director of research and development at Thermo Fisher Scientific. "In combination with our full portfolio, including the Gibco CTS DynaCellect Magnetic Separation System and the Gibco CTS Rotea Counterflow Centrifugation System, we are confident that this collaboration will significantly shorten and enhance the manufacturing workflow for cell therapies in this space, ultimately helping our customers make the world a healthier place."

On June 24, 2025 Corner Therapeutics, an immunotherapy company pioneering novel approaches to cancer and infection, reported that its Distinguished Scientist, Scientific Co-founder and Board Member, Professor Jonathan Kagan, Ph.D., will deliver an invited oral presentation at the 25th Annual Meeting of the Federation of Clinical Immunology Societies (FOCiS 2025), taking place from June 24 to 27 in Boston, MA (Press release, Corner Therapeutics, JUN 24, 2025, View Source [SID1234654099]).

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On June 24, as part of the Member Society Symposia: Innate Immunotherapy in Cancer: Bridging Fundamental Mechanisms and Clinical Trials, Professor Kagan will present new preclinical and human data demonstrating the ability of Corner’s novel mRNA-encoded immunotherapies to drive durable tissue-resident T cell responses through STING pathway agonism. The presentation will focus on applications in cancer vaccines.

Presentation Details
Title: mRNA-encoded Adjuvant Enzymes Unlock Anti-tumor T-cell Immunity
Date/Time: June 24, 4:30-5pm ET
Location: Boston Marriott Copley Place, Arlington meeting room, Boston, MA

Professor Kagan co-founded Corner Therapeutics in 2019 with the goal of developing immunotherapies through the exquisite control of the innate immune system. Based on Professor Kagan’s research, Corner’s mRNA-based and dendritic cell hyperactivating platforms instruct the innate immune system to engineer its own long-lived, disease-fighting T cells.

Last year, Corner launched its $54 million Series A investment round. The company now partners with leading biopharma companies and nonprofits including the Bill & Melinda Gates Foundation to fully realize the protective promise of both therapeutic and preventative vaccines.

On June 24, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that it received positive written feedback from the US Food & Drug Administration ("FDA") Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma (Press release, OS Therapies, JUN 24, 2025, View Source [SID1234654098]). The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT.

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Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company’s overall regulatory strategy and timelines.

"We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA’s current position and allows us to be fully prepared for the End of Phase 2 Meeting."

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale occurred in June 2025, valued at $160 million.

The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million.

OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on PBS’ website.