On October 27, 2025 Tolerance Bio, a biopharmaceutical company pioneering innovative approaches to extending healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, reported the publication of a scientific article titled "Patient-specific autologous thymic organoids support functional T-cell education leading to antitumor activity in humanized mice with melanoma xenografts" in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The research was led by Antonio Jimeno, M.D., Ph.D., from the Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine, and Holger A. Russ, Ph.D., from the Diabetes Institute and the Department of Pharmacology and Therapeutics, College of Medicine at the University of Florida, Gainesville, and scientific co-founder of Tolerance Bio.

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The contributing teams utilized a novel approach, implanting patient-derived thymic cells generated via direct differentiation of induced pluripotent stem cells (iPSCs) into thymectomized and humanized immune-deficient mice, along with matched tumor tissues from a patient with metastatic melanoma. The key finding was that tumors implanted in mice with human thymic tissue grew significantly slower compared to tumors implanted in control and in humanized mice without thymic tissue. Viable melanoma content was also significantly decreased in mice bearing thymic organoids, associated with an increase in intra-tumoral activated T-cells. Whole gene sequencing identified multiple candidate neoantigens that were eliminated in cancer cells in thymus-bearing mice, suggesting a more effective identification and T-cell-driven tumor clearance.

"An experiment is only as good as the models used to conduct it. Over the last 15 years, we have generated increasingly complex laboratory and mouse models that can bear both human immune and cancer cells, which we call humanized mice, to realize the promise of immune therapy. A fundamental limitation of humanized mice, generated with donor blood stem cells and implanted with mismatched patient tumors, is that the fidelity of the interaction between the immune and tumor cells is limited by lack of the organ that facilitates immune cell education, the thymus," said Dr. Jimeno.

"Here we report the successful generation of a novel model that incorporates functional thymic organoids derived from iPSC generated using patient peripheral blood with tumors from the same patient, providing an important step towards improved personalized models," remarked Dr. Russ.

"These results represent meaningful advance in oncology, both from a therapeutic and a diagnostic point of view, as iPSC thymic cells have the potential to serve as a cell therapy for cancer, alone or along immune agents, the patient derived xenograft model can improve new drug development by more accurately identifying promising drugs and vaccines, and it will allow for personalized medicine by testing which immune therapy is more likely to work for a specific patient," added Dr. Jimeno. "We have a lot of work ahead, but I am looking forward to extending our interdisciplinary work into the future to realize this potential."

"Tolerance Bio is proud to collaborate with Dr. Jimeno and Dr. Russ, and their superb teams at U. Colorado and U. Florida. Their work lays the foundation for the use of iPSC thymic cells in immune diseases, including cancer," said Dr. Francisco Leon, M.D., Ph. D., CEO of Tolerance Bio. "The changes in the tumor growth kinetics provide critical proof of principle for the ability of iPSC thymic cells to reconstitute a T cell immune system in vivo with beneficial functional consequences. As we advance towards the clinic, we have developed a robust manufacturing process for our allogenic, off-the-shelf iPSC thymic cell product, and we plan to initiate pre-investigational new drug (IND) studies in the near future."

(Press release, Tolerance Bio, OCT 27, 2025, View Source [SID1234657047])

On October 27, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it has appointed Dr Helen Tayton-Martin as new Chief Executive Officer (CEO). She will take up her new position on November 24, 2025, and simultaneously step down from Evaxion’s Board of Directors (Board).

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Holding a Ph.D. in molecular immunology, and an MBA from London Business School, Helen Tayton-Martin was a co-founder of cancer-focused biotech company Adaptimmune, where she served as Chief Operating Officer and later Chief Business & Strategy Officer during her 17 years with the company. Through this time, she oversaw transatlantic growth, multiple clinical, academic and commercial collaborations and private and public financing through to its Nasdaq IPO. Dr. Tayton-Martin was responsible for all Adaptimmune’s strategic partnerships including those with Astellas, Genentech, a member of the Roche Group, GlaxoSmithKline and Galapagos NV.

Prior to Adaptimmune, Dr. Tayton Martin spent 15 years working within the pharma, biotech and consulting environments for various companies. She also previously served as a non-executive director of Trillium Therapeutics Inc. from October 2017 through to the sale of the company in November 2021 to Pfizer Inc.

"I am delighted that Helen Tayton-Martin is taking over the CEO position. She is a skilled executive with exactly the right experience in leading an organization, making partnerships and monetizing assets in biotech. Helen knows Evaxion from her time on the Board and we have seen her leadership quality and have already established a working relationship. It is with great faith that we welcome her to a new role in the company" says Marianne Søgaard, Chairman of the Board at Evaxion.

"I also want to extend my thanks to Birgitte Rønø, who has done a fantastic job as interim CEO in a crucial time for Evaxion, on top of her duties as Chief Scientific Officer. Birgitte will now again focus on this role, and we look forward to continuing to benefit from her capabilities and experience as she leads our research and development work," says Marianne Søgaard.

"I am very excited to be joining Evaxion as CEO at an incredibly exciting time for the company. I have seen first-hand from my time on the Company’s Board the strength of its AI-Immunology platform to deliver real potential products, exemplified with the recent out-licensing of EVX-B3 to MSD and the presentation of unprecedented data for EVX-01 at ESMO (Free ESMO Whitepaper), demonstrating Evaxion is in a very strong position for further future value generation. I am looking forward to working with the highly skilled and committed team of employees to build from this extraordinary scientific, medical and commercial potential of Evaxion," says Helen Tayton-Martin.

Changes to the Board of Evaxion
Helen Tayton-Martin will step down from the Board of Evaxion when taking up the CEO position. Seasoned life science executive Jens Bitsch-Norhave will join the Board of Directors as adviser and observer with the intention of seeking election as board member at the Annual General Meeting in 2026.

"We are looking forward to welcoming Jens Bitsch-Norhave to Evaxion. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong addition to the Board", says Marianne Søgaard.

Jens Bitsch-Norhave is currently Corporate Vice President and Global Head of Corporate Development at Hengrui Pharmaceuticals, where he is responsible for strategy, business development, licensing, M&A, and alliance management, advancing the company’s globalization and growth. He holds an MSc and Ph.D. in neuropharmacology from the University of Copenhagen and an Executive MBA in Technology & Innovation from Copenhagen Business School.

(Press release, Evaxion Biotech, OCT 27, 2025, View Source [SID1234657032])

On October 27, 2025 OncoNano Medicine, Inc. ("OncoNano") reported encouraging first-in-human results from Part 1 of its Phase 1 ON-5001 trial evaluating ONM-501, a dual-acting STING agonist, as monotherapy and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor, in patients with advanced solid tumors and lymphomas. The findings were shared during a poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts.

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ONM-501 is designed to activate the STING pathway and stimulate both innate and adaptive immune responses within the tumor microenvironment. By linking a cyclic dinucleotide (cGAMP) to a proprietary polymer, ONM-501 prolongs STING activation and overcomes key limitations of earlier STING agonists. In preclinical models, this approach produced durable anti-tumor responses without triggering systemic inflammation, an effect now supported by emerging clinical results.

In the dose-escalation and dose-finding study, ONM-501 was well tolerated and demonstrated early signs of clinical benefit. Among 39 patients treated (15 with ONM-501 monotherapy and 24 in combination with cemiplimab), no dose-limiting toxicities were observed, and the most common adverse events were mild fatigue and injection-site reactions. Systemic interferon-γ levels remained within normal limits across all cohorts.

In the monotherapy arm, one patient achieved an objective response and three patients had prolonged stable disease, including a case of recurrent, immunotherapy-refractory uveal melanoma with disease control lasting over one year (390 days). In the combination arm, five patients experienced objective responses, including two complete in patients with cutaneous squamous cell carcinoma (cSCC).

"These data provide the first clinical evidence that sustained STING activation through our proprietary polymer conjugate can drive meaningful immune responses in solid tumors," said Kartik Krishnan, MD, PhD, Chief Executive Officer of OncoNano Medicine. "The safety profile and emerging efficacy signals, particularly in patients with advanced cutaneous malignancies, highlight the potential of ONM-501 to expand the reach of STING-based immunotherapy."

Part 2 of the ON-5001 study (NCT06022029) is now open and enrolling patients with advanced basal cell carcinoma, cutaneous squamous cell carcinoma and melanoma.

About ONM-501
ONM-501 is a dual-activating agonist of the stimulator of interferon genes ("STING") pathway composed of cGAMP (the endogenous activator of STING) linked to a proprietary pH-activated polymer (the OMNI polymer). ONM-501 is presently being studied in a Phase 1 clinical trial (ON-5001). In preclinical models, the dual activation of STING by ONM-501 has been shown to lead to a direct anti-tumor effect, as well as leading to an anti-tumor immune response over an extended period of time. Development of ONM-501 was funded in part by the Cancer Prevention and Research Institute of Texas.

(Press release, OncoNano Medicine, OCT 27, 2025, View Source [SID1234657048])

On October 27, 2025 GSK plc (LSE/NYSE: GSK) and Syndivia, a private biotechnology company focused on next-generation ADCs, reported an agreement granting GSK exclusive worldwide rights to develop and commercialise a preclinical ADC for mCRPC.

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Approximately 1.4 million men worldwide are diagnosed with prostate cancer each year and approximately 10-20% develop advanced disease, castration resistance with metastases, within five years.1 For patients whose cancer has advanced to mCRPC, targeted treatment options are limited, and standard of care options may be difficult to access in community practice settings, and can be poorly tolerated with modest efficacy outcomes. Survival rates for these patients are low, with a 5-year survival rate of approximately 30% and a median survival of approximately two years.2,3,4

The novel ADC, which utilises Syndivia’s next-generation GeminiMab conjugation technology, has shown enhanced anti-tumour activity and an encouraging safety profile, demonstrating best-in-class potential. In preclinical studies, the ADC was effective at shrinking tumours without causing a proportional increase in significant side effects, even at higher doses. This ADC could provide a targeted treatment directly to the tumour, currently a gap in available therapies, along with a more easily accessible treatment in the community practice setting for mCRPC.

GSK is developing an innovative pipeline that spans ADCs with distinct antigens and payloads, next-generation small molecules, and T-cell engagers. These diverse approaches, such as GSK’227 and this novel ADC, enable GSK to advance potential therapeutic options across various stages and types of prostate cancer.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "Prostate cancer represents a significant health burden and an emerging area of growth for GSK, where targeted therapies are urgently needed in metastatic castration-resistant settings. The addition of this ADC builds on GSK’s growing portfolio and strengths in tumour-targeted technologies, including GSK’227, our B7-H3-targeting ADC."

Sasha Koniev, Chief Executive Officer, Syndivia, said: "We are proud that GSK will advance this programme on a global scale. This agreement underscores the value of our GeminiMab ADC platform and the opportunity to bring a promising new therapy to patients with pressing unmet medical needs."

Financial considerations
Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million. They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program.

(Press release, GlaxoSmithKline, OCT 27, 2025, View Source [SID1234657033])

On October 27, 2025 Guardant Health (Nasdaq: GH), a leading precision oncology company, and Zephyr AI, a leader in precision medicine harnessing artificial intelligence to accelerate drug development, reported a strategic partnership to deliver novel, scalable, and actionable insights that support biopharmaceutical innovation. This collaboration will combine unique multimodal molecular data and AI/ML technology from both companies driving advancement of novel cancer biomarkers for drug development, targeted therapies selection, and response monitoring.

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The partnership will be integrated with Guardant’s broader suite of Infinity AI capabilities and exemplifies both companies’ broader commitment to harnessing AI and multimodal data to empower oncologists, researchers, and biopharma developers with solutions to transform cancer patient care.

"At Guardant Health, we’ve always believed that data is key to conquering cancer," said Helmy Eltoukhy, chairman and co-CEO of Guardant Health. "By combining our industry-leading molecular data with Zephyr AI’s advanced analytics platform, we’re taking another major step toward realizing the full potential of precision oncology—helping our biopharma partners accelerate drug development and ultimately deliver better outcomes for patients worldwide."

Through the combination of Guardant Health’s multimodal real-world data and precision oncology insights and Zephyr’s proprietary AI technologies, the partnership will accelerate research and development for biopharma partners. This model is unique in its capability to generate predictions of targeted cancer therapy response validated by real-world data, integrating biologic interpretability features that result in actionable scientific intelligence.

"This collaboration represents the convergence of unmatched real-world data, leading-edge diagnostics and cutting-edge machine learning to enable more precise, scalable, and impactful oncology solutions," said Allen Chao, CEO of Zephyr AI. "By working together, Guardant Health and Zephyr AI can supercharge discovery and development needed to transform cancer treatment and deliver on the promise of personalized medicines for cancer patients."

(Press release, Guardant Health, OCT 27, 2025, View Source [SID1234657049])