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.

On June 24, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage diagnostics and targeted therapeutics for cancer, reported that the China National Intellectual Property Administration (CNIPA) has issued a notification of patent grant for the company’s novel composition and method for selectively killing cancer by targeting the CD320 and LRP2 receptors on the cell membrane (Press release, BioAffinity Technologies, JUN 24, 2025, View Source [SID1234654097]).

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The newly allowed Chinese patent – titled "Compositions and Methods for Treating Cancer" – adds important global protection for bioAffinity’s innovative RNA-based therapeutic strategy and covers siRNAs and their use in cancer treatment, which is also protected by the Company’s new U.S. Patent No. 12,305,171.

The invention uses small interfering RNAs (siRNAs) to suppress the expression of CD320 and LRP2 proteins. In vitro research demonstrates this siRNA-driven double knockdown effectively targets cancer cells from multiple tumor types, including lung, breast, prostate, brain, and skin, without harming normal cells, suggesting a universal mechanism of action.

bioAffinity is exploring the application of this technology as a topical treatment specifically designed for cutaneous malignancies and neoplasms of the skin. This development aligns closely with the Company’s broader strategy of addressing cancer through both early-stage diagnostics, exemplified by CyPath Lung, and innovative therapeutic approaches.

"This newly allowed patent expands our global intellectual property portfolio and strengthens our position in developing siRNA-based therapies that exploit a fundamental vulnerability in cancer cells," said William Bauta, PhD, Chief Science Officer at bioAffinity Technologies. "Our research has shown that silencing CD320 and LRP2 leads to cancer cell death without harming normal cells – a highly selective approach with potential for broad therapeutic application."

bioAffinity continues to advance its high-growth core diagnostic platform, CyPath Lung, an accurate, noninvasive test for early-stage lung cancer detection, while simultaneously leveraging its scientific expertise toward novel therapeutic solutions that address critical unmet medical needs in oncology.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On June 24, 2025 Accord Healthcare Limited (Accord) reported that the anti-PD-1 mAb, serplulimab, marketed as Hetronifly, has been approved by the MHRA to treat adults in the UK with extensive-stage small cell lung cancer (ES-SCLC), which has not previously been treated and has spread within the lungs or to other parts of the body (Press release, Accord Healthcare, JUN 24, 2025, View Source [SID1234654096]).

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This approval comes in the same week as the announcement in India, bringing the total number of countries and regions in which the medicine is approved to over 40 — including Europe, China, Indonesia, and Singapore. Accord Healthcare will lead commercialisation in both the UK and India on behalf of its parent company, Intas, and its commercial partner, Henlius.

Lung cancer remains the leading cause of cancer-related death globally. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options[1].

Julian Beach, Interim Executive Director of Healthcare Quality and Access at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), commented: "As the first and only anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis."[2]

Henlius Biotech originally developed Serplulimab. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise the medicine in over 50 countries across Europe and India.

Welcoming the news, Paul Tredwell, Executive Vice-President EMENA, Accord Healthcare, said: "At Accord, we are dedicated to supporting patients with cancer. The MHRA’s approval of Hetronifly provides a new treatment option in the fight against extensive-stage small cell lung cancer — one of the most aggressive forms of lung cancer. This milestone reflects our ongoing commitment to providing novel specialty medicines for difficult-to-treat conditions."

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius said: "The approvals of serplulimab in the UK and India not only represent continued progress in our globalisation strategy but also reflect our concrete commitment to putting patients first. We are steadily expanding the global reach of the product, aiming to bring high-quality innovative therapies to more patients around the world."

In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC, this was recently reviewed by the committee and renewed.

ESMO has also scored serplulimab 4 out of 5 on their magnitude of clinical benefit scale (MCBS) in ES-SCLC.

About Serplulimab

Serplulimab (recombinant humanised anti-PD-1 monoclonal antibody injection)) is an anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China and several SEA countries. Serplulimab has been approved by the National Medicinal Products Administration (NMPA) in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. Furthermore, serplulimab was respectively recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours.

The approvals were primarily based on the results of the global phase 3 clinical study ASTRUM-005, which enrolled 585 patients across 128 trial sites worldwide. At the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the results from the final analysis of ASTRUM-005 were presented, showing a median follow-up of 42.4 months and a 4-year overall survival (OS) rate of 21.9% (95% CI: 17.6–26.6%) for the serplulimab plus chemotherapy group. These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.

About Lung Cancer

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.[1]

Small cell lung cancer (SCLC), which accounts for 15% to 20% of all lung cancers, is characterised by high malignancy, early metastasis, rapid progression, and poor prognosis.

Among SCLC patients, approximately 30% to 40% are diagnosed at a limited stage, while the remaining cases are in an extensive stage.

Within Europe, the prevalence of SCLC ranges from 1 to 5 per 10,000 people.