On October 1, 2026 Roswell Park Comprehensive Cancer Center ("Roswell Park") and Generate Biomedicines, Inc. ("Generate") reported that the first patient has been dosed in a first-in-human clinical trial evaluating GB-5267, an investigational, autologous IL-18 armored CAR T-cell therapy designed to overcome key barriers that have limited the success of cellular therapies in ovarian cancer and other solid tumors. GB-5267 targets the antigen MUC16, which is over-expressed by more than 80% of ovarian tumors and helps them grow, spread, and hide from the immune system. The trial is recruiting patients whose disease has returned after treatment or does not respond to platinum-based chemotherapy, the standard first-line treatment.

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Led by Principal Investigator Emese Zsiros, MD, PhD, FACOG, Chair of Gynecologic Oncology at Roswell Park, the phase 1 clinical trial (NCT07489287) will evaluate the safety and tolerability of GB-5267.

Each patient’s T cells, immune cells capable of killing cancer cells, will be collected, genetically engineered, and expanded in Roswell Park’s GMP Engineering & Cell Manufacturing Facility before being returned to the patient to target an attack against the tumor.

While T-cell therapies have revolutionized the treatment of blood cancers, leading to long-term remission or even cure for many patients, solid tumors — cancers that grow in organs or tissue — have posed more of a challenge. That’s because the tumor’s microenvironment, a protective cocoon that surrounds it, prevents immune cells from entering the tumor or even being able to recognize it. But investigators believe they have found a way around that roadblock.

"We’re armoring the T cells with IL-18, a cytokine that will help protect them from the suppressive microenvironment of the solid tumor," explains Marco Davila, MD, PhD, Senior Vice President and Associate Director for Translational Research at Roswell Park. Dr. Davila co-developed some of the first CAR T-cell therapies and has played a key role in refining them.

"Because ovarian cancer spreads through the peritoneal cavity, the CAR T-cell therapy will be delivered in two ways: intravenously and into the peritoneal cavity," adds Dr. Zsiros. "This strategy is designed to concentrate the immune response where it is needed, without the toxicity of high-dose chemotherapy."

GB-5267 was engineered by Generate with AI through the design and evaluation of CAR architectures at scale based on how T cells actually behave, rather than relying on binding affinity as a proxy for performance. GB-5267 was designed to optimize three interdependent functions required for CAR T-cell performance in solid tumors:

Potency, the ability to kill MUC16-expressing tumor cells
Proliferation, the ability to expand into a larger T-cell population
Persistence, the ability to remain active over time in a suppressive tumor microenvironment

"Recognizing a tumor antigen is only one part of the challenge. In solid tumors, a CAR T cell that kills but does not expand or persist is a partial solution. GB-5267 was computationally designed with potency, proliferation, and persistence to maintain activity in a suppressive tumor microenvironment. Dosing the first patient begins the clinical test of whether that function-first approach behaves in patients as intended," says Dinesh de Alwis, PhD, Senior Vice President and Head of Clinical Drug Development at Generate Biomedicines.

Unlike many CAR T-cell approaches, this study will not require lymphodepletion, which uses chemotherapy to reduce the patient’s original immune cells to provide more space for the new cells. That means patients will not be exposed to the side effects associated with chemotherapy.

Typically, ovarian cancer is treated with surgery followed by platinum-based chemotherapy. When the disease recurs, it often no longer responds to chemotherapy, at which point it is very difficult to treat, with few options. The five-year relative survival rate for the disease is only 51.6%.

"CAR T-cell therapy has transformed outcomes in blood cancers," says Dr. Zsiros. "With this clinical trial, we are working to bring that progress to people with ovarian cancer."

Research leading to this clinical trial was made possible in part by donations to the Roswell Park Alliance Foundation’s Igniting Cancer Breakthroughs campaign and through events like Ride for Roswell.

(Press release, Generate Biomedicines, OCT 1, 2026, View Source;docid=6a8c470cfd9da29fbe47c53131417eea49df4ad9&content=prnews&format=html [SID1234671219])

On October 1, 2026 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the completion of the first dose cohort in its ongoing first-in-human Phase I trial of IDOV-2 (formerly, IDOV-Immune) in patients with advanced solid tumors (NCT06910657). Following its review of safety data from this cohort, the trial’s independent Safety Review Committee (SRC) cleared the study to proceed to the next, higher dose cohort. The trial is being conducted in the United States, as well as in Australia through ViroMissile’s subsidiary, ViroMissile Australia, PTY, LTD.

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The company also reported that multiple patients in the initial cohort currently have stable disease across multiple solid tumor types, including one patient with confirmed stable disease at six months. These early signals of anti-tumor activity following a single intravenous (IV) dose of IDOV-2, even at starting dose levels, are notable because oncolytic virus (OV) development has largely been confined to tumors accessible by intratumoral or local injection, since IV-dosed OVs are typically cleared by the immune system before they can spread effectively to and within tumors. The company’s proprietary platform leverages an engineered vaccinia strain with increased production of extracellular enveloped virus (EEV) to potentially enhance spread between cancer cells and reach a broader range of cancers through effective and efficient systemic administration.

"Clearance from the Safety Review Committee to move into the next dose cohort is an important validation of the tolerability profile we’ve seen so far, and it keeps this trial moving at the pace our patients deserve," said Nanhai George Chen, PhD, CEO and founder of ViroMissile. "We are especially encouraged to see confirmed stable disease at six months in a patient treated at our lowest planned dose. It is an early but potentially meaningful signal that IDOV-2 is doing what we engineered it to do, causing the tumor itself, regardless of solid tumor type, to become an anti-tumor "drug" factory, delivering cytokines, chemokines, or other proteins to kill the tumor."

Shah Rahimian, MD, chief medical officer at ViroMissile, added, "Successfully completing this first cohort gives us confidence as we advance to higher, potentially more active dose levels. We are grateful to the investigators and patients who made this milestone possible, and we look forward to building on this early signal of clinical benefit as enrollment continues."

The Phase I, open-label, multi-center trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of a single intravenous (IV) infusion of IDOV-2. The study plans to enroll up to 78 adult participants at leading cancer centers across the United States and Australia using a dose-escalation design to determine the maximum tolerated dose and recommended dose for Phase 2 studies. Secondary objectives include evaluating the PK and PD profile of IDOV-2, characterizing immunologic responses and the development of neutralizing antibodies, and assessing preliminary signs of antitumor activity, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) over a 12-month follow-up period.

(Press release, ViroMissile, OCT 1, 2026, View Source [SID1234671217])

On October 1, 2026 Sanofi and Regeneron Pharmaceuticals, Inc. reported an expansion of their longstanding antibody collaboration, adding multiple next-generation, long-acting antibodies to the Alliance that has jointly established Dupixent (dupilumab) as the world-leading treatment for diseases driven by type 2 inflammation. The agreement builds on the companies’ more than 20-year collaboration, through which more than 1.5 million people are currently receiving Dupixent across nine indications, making it one of the most widely used antibody medicines in the world.

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"This is a deliberate first step in igniting Sanofi’s innovation engine. Our longstanding Alliance with Regeneron has transformed the treatment landscape for millions of patients living with diseases driven by type 2 inflammation and created one of the world’s leading immunology businesses," said Belén Garijo, Chief Executive Officer of Sanofi. "By deepening our collaboration, we will make rapid progress in creating the next generation of meaningful therapies for patients with immune-mediated diseases, while contributing to Sanofi’s long-term future."

Under the expanded license and collaboration agreement, the companies will co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies targeting interleukin-13 (IL-13), IL-4xIL-13 bispecific, interleukin-4 (IL-4) and interleukin-4 receptor alpha (IL-4Rα). IL-13 antibody REGN20423 is currently in a phase 1 clinical study for atopic dermatitis, and the other three antibodies are expected to enter clinical studies in 2027. Regeneron will also have the option to include in the collaboration Sanofi’s lunsekimig, an investigational bispecific Nanobody VHH therapy targeting TSLP and IL-13, exercisable upon completion of its phase 3 studies for chronic obstructive pulmonary disease.

"The Regeneron-Sanofi Alliance has been one of the most productive in biopharma history. This agreement builds on that foundation to bring the next generation of immunology medicines to patients even faster," said Leonard S. Schleifer, MD, PhD, Board co-Chair, President and Chief Executive Officer of Regeneron. "By expanding our Alliance, we are positioning promising new long-acting antibodies for the kind of rapid, global impact that our shared work on Dupixent has already achieved."

Under the terms of the agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi, with the potential for development, regulatory and commercial milestone payments of up to an additional $7 billion. The companies will share development and commercialization costs for the new programs and will split future profits from these potential products 50:50 on a global basis. Regeneron will lead research and development activities, and Sanofi will lead global commercial efforts. The existing profit-sharing agreement regarding Dupixent will not change.

"The companies’ clinical and commercial Alliance dates to 2003 and has resulted in multiple approved medicines to date, including Dupixent, which has redefined the standard of care for people with type 2 inflammatory diseases and is now one of the most widely used antibodies for any disease, with over 1.5 million active patients worldwide," said George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. "By combining Regeneron’s world-class scientific discovery and antibody development expertise with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology."

The companies have settled their prior collaboration-related litigation.

Conference call for investors and analysts

Sanofi and Regeneron will host a conference call for investors and analysts today at 14:00 CET/8:00am ET. A presentation will be available for download from the Investor Relations section of sanofi.com and regeneron.com when the conference call starts.

Participants may access the conference call via webcast on the ‘Upcoming Events’ page of Sanofi’s website at View Source, tab ‘Presentations’ and on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link.

About Dupixent

Dupixent, which was invented using Regeneron’s proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

(Press release, Sanofi, OCT 1, 2026, View Source [SID1234671216])

On October 1, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (OTCMKTS: RKVTF) a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, reported a research collaboration with Boston-based Celvion Therapeutics ("Celvion") to leverage Celvion’s proprietary EMphora artificial intelligence platform to identify novel precision medicine strategies designed to accelerate the development of Rakovina’s ATR inhibitor program.

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The collaboration will initially focus on indications where EMphora will analyze large-scale clinical outcomes and real-world patient data to identify therapeutic targets that may enhance the activity of Rakovina’s ATR inhibitor. In addition to evaluating potential drug combinations, the analysis will search for previously unrecognized therapeutic opportunities, predictive biomarkers, and patient subgroups most likely to benefit from ATR-targeted therapies.

Unlike conventional preclinical discovery approaches, the collaboration will utilize artificial intelligence to interrogate real-world clinical evidence, helping identify the most promising drug combinations and patient populations before advancing into further development. By combining Rakovina’s expertise in synthetic lethality and DNA damage response therapeutics with Celvion’s AI-powered clinical discovery platform, the companies aim to improve development efficiency, reduce clinical risk, and accelerate the delivery of precision medicines to patients with difficult-to-treat cancers.

The companies expect the analysis to generate clinically actionable hypotheses that will help prioritize future combination studies, guide biomarker-driven patient selection strategies, and inform the design of subsequent clinical development programs.

"We have learned how to use multiple specialized AI platforms to accelerate the drug discovery and development process rather than relying on a single platform. Our team selects the right tool for each challenge, from generative design to large-scale screening, to develop molecules that exploit vulnerabilities in how cancer cells repair DNA damage," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "Working with Celvion extends that approach into clinical strategy, using advanced AI to identify the patient populations and drug combinations where our ATR inhibitor program can have the greatest impact."

"EMphora was built to uncover meaningful therapeutic insights directly from clinical outcomes and existing patient data," said Mi Yang, Chief Executive Officer of Celvion Therapeutics. "By collaborating with Rakovina, we have an opportunity to identify combination therapies and biomarkers that may not be apparent through conventional research methods. Our objective is to generate actionable evidence that helps guide smarter clinical development and ultimately benefits patients."

"Synthetic lethality offers tremendous promise in oncology, but its greatest impact will come from identifying the right combinations for the right patients," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "This collaboration gives us the opportunity to rigorously evaluate ATR-based combination strategies while exploring additional biomarkers and therapeutic targets that could further enhance clinical benefit. These insights will help shape the next generation of our development strategy."

Rakovina and Celvion intend to commit appropriate scientific, technical and other resources to support the collaboration and advance the resulting opportunities. As the work progresses and promising development opportunities are identified, the companies expect to explore appropriate co-development and economic arrangements to support subsequent stages of development.

The collaboration reflects Rakovina’s broader strategy of integrating cutting-edge computational biology, translational science, and precision oncology to build a smarter, faster, and more targeted approach to cancer drug development. By leveraging artificial intelligence alongside world-class science, Rakovina continues to position itself at the forefront of precision oncology innovation with the goal of delivering transformative therapies for patients facing significant unmet medical needs.

(Press release, Rakovina Therapeutics, OCT 1, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-partners-with-boston-based-celvion-therapeutics-to-leverage-ai-and-real-world-clinical-data-for-precision-cancer-drug-development [SID1234671215])

On October 1, 2026 Quest Diagnostics reported a new study published in The Journal of Molecular Diagnostics showed that the Haystack MRD test is highly accurate at detecting residual and recurrent disease, demonstrating clinical performance in specimens from the landmark DYNAMIC colorectal cancer trial series. The study also validated the test’s analytical performance across 23 solid tumor types. Haystack MRD is an ultrasensitive circulating tumor DNA (ctDNA) liquid biopsy test for identifying residual or recurrent disease in patients with solid tumor cancers.

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The study evaluated the clinical performance of the commercially available Haystack MRD test by retrospectively testing residual specimens from patients enrolled in the DYNAMIC and DYNAMIC-III trials, which evaluated the use of ctDNA-based MRD results (generated with an earlier version of the Haystack MRD technology) to guide chemotherapy decisions in stage II and III colorectal cancer. In this cohort, Haystack MRD results were highly associated with recurrence, demonstrating 100% sensitivity and 100% specificity at 3-year follow-up and 83.3% sensitivity and 100% specificity at 5-year follow-up. Haystack MRD also substantially outperformed carcinoembryonic antigen (CEA), a standard blood-based biomarker, detecting recurrence with 88.9% sensitivity versus 11.1% for CEA (median follow-up 60 months).

Scientists from Quest and Haystack Oncology conducted the study together with investigators from the two institutions that led the DYNAMIC trials: The Walter and Eliza Hall Institute of Medical Research and the Peter MacCallum Cancer Center in Melbourne, Australia.

"The DYNAMIC trial demonstrated the potential for ctDNA to guide more individualized treatment decisions in stage II colon cancer but realizing that potential depends on a highly sensitive assay that can reliably detect the extremely small amounts of tumor DNA that may remain after treatment, while maintaining high specificity," said Professor Jeanne Tie,* a medical oncologist at Peter MacCallum Cancer Centre and lead investigator for the DYNAMIC trial series. "This study helps bridge the gap between clinical research and real-world patient care."

In other key findings, Haystack MRD:

Demonstrated ultrasensitive detection of residual disease, with a 95% limit of detection (LoD95) of 0.063 mean ctDNA molecules per milliliter (mL) of plasma. Earlier validation established an LoD95 of 6 parts per million (PPM), a metric commonly reported for tumor-informed MRD assays1.
Achieved sub-PPM detection of 0.8 PPM, and as low as 0.2 PPM in some samples, with no false positives in cancer-free controls using an investigational whole-genome version of the test. This whole-genome version is currently only available to clinical investigators and biopharma partners while the commercial test uses whole-exome sequencing.
Established a limit of quantitation (LOQ) suitable for response monitoring of 0.25 mean ctDNA molecules per mL. Establishing the LOQ allows a change in a patient’s ctDNA level between serial tests to be interpreted as a real change in tumor burden rather than assay variability.
Demonstrated analytical performance across the complete testing process, starting from plasma collection and including cell free (cf) DNA extraction, rather than starting with already extracted cfDNA. As a result, analytical performance can be directly translated to clinical performance, versus assay validations that begin with extracted cfDNA and do not account for extraction variability.
"To our knowledge, this is the first time that the full ctDNA MRD testing process, starting from plasma collection and including cfDNA extraction, has been characterized for the limit of detection (at 95%) and quantitative analytical performance," said study co-author Dan Edelstein, Vice President and General Manager, Haystack Oncology. "The precise quantitative measurements demonstrated in this validation provide confidence that the Haystack MRD test accurately measures changes in ctDNA levels over time and can be used for serial ctDNA monitoring during and after treatment. With these insights, clinicians can understand the degree of change in ctDNA levels related to tumor biology in an individual patient, supporting earlier evaluation of treatment response and detection of molecular progression or recurrence."

In addition, the study examined a real-world clinical cohort from an Early Experience program in which Haystack MRD detected ctDNA across 27 solid tumor types, including at ultra-low concentrations, with 42% of positive results below 0.5 mean ctDNA molecules/mL.

The new study adds to the growing body of evidence supporting the clinical value of Haystack MRD, following two studies published in The New England Journal of Medicine. Published in 2022, DYNAMIC was the first prospective, interventional study to demonstrate the clinical utility of ctDNA-based MRD testing to reduce the use of chemotherapy in stage II colon cancer without compromising recurrence-free survival. In 2025, a study on response to immunotherapy in mismatch repair-deficient cancers found that the Haystack MRD test was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared with more than 6 months using imaging.

(Press release, Quest Diagnostics, OCT 1, 2026, View Source [SID1234671214])