On October 29, 2025 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported that it has entered into a license and collaboration agreement with Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) to discover and develop multispecific antibodies for several therapeutic indications of mutual interest. The collaboration will apply ModeX’s MSTAR platform and Regeneron’s proprietary binders to develop multispecific antibody candidates that target multiple distinct biological pathways in a single molecule.

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Under the terms of the agreement, ModeX will receive an upfront payment of USD $7 million, and potential future product selection payments, clinical and regulatory milestone payments, and commercial milestone payments exceeding USD $200 million per selected molecule. The overall value of the collaboration potentially exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered global net sales royalties, up to low double digits at the highest tier. Regeneron will fund and lead any preclinical, clinical development and commercialization activities for any products it elects to advance.

"This agreement allows us to work closely with Regeneron, world leaders in the development of antibody medicines, to explore the promise of multispecific antibodies in new indications, including immunology, oncology and metabolic diseases. ModeX’s mission is to develop innovative antibodies that recognize multiple targets in a single molecule to treat life-threatening diseases," said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX and Chief Innovation Officer of OPKO Health.

"We have dramatically expanded the therapeutic potential of antibodies through our MSTAR platform. Our antibody candidates are already in clinical trials, providing unique disease target combinations and reliable manufacturing," said Elias Zerhouni, M.D., President and Vice Chairman of OPKO. "We believe this collaboration, with Regeneron’s outstanding team, will advance the development of multispecific antibodies across a spectrum of chosen indications in several disease areas of high interest to both parties."

"Like Regeneron, ModeX has a team of scientist entrepreneurs who think creatively about science and technology," said George D. Yancopoluos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron. "By pairing Regeneron’s expertise in drug development with ModeX’s platform for multispecific antibodies, we are building on Regeneron’s longstanding work in bi-and multi-specific antibodies and increasing our shots on goal by identifying more candidates faster to potentially help patients across multiple disease categories."

Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)

Multispecific antibody therapeutics can help generate medicines of the future by targeting three or more disease pathways simultaneously. Many untreatable or complex conditions arise from multiple disease pathways; yet, most medicines only act on a single target. ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.

(Press release, Opko Health, OCT 29, 2025, View Source [SID1234657109])

On October 29, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration ("FDA") to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-002 trial and a proposed amendment to the VERSATILE-003 Phase 3 trial to reduce the number of patients, while maintaining statistical power, and to add progression free survival (PFS) as an earlier primary endpoint in addition to median overall survival (mOS). If the PFS endpoint is met, it would allow for an accelerated approval submission to the FDA. While the Company’s trial amendment is undergoing review by the FDA, the VERSATILE-003 trial will be temporarily paused.

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"The final survival results and durable clinical responses from our VERSATILE-002 trial are very exciting. It’s the first time that a trial in the recurrent/metastatic HNSCC population has reported a mOS of almost 40 months," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "The fact that our Phase 3 study has mOS as its primary endpoint and PFS as a secondary endpoint inherently lengthens the duration of the trial. To shorten the trial duration, we believe a meeting with the FDA to discuss changes to the current trial protocol to include PFS as an earlier primary endpoint independent of mOS is warranted. We look forward to keeping all PDS Biotech stakeholders informed as our discussions with the FDA progress."

Dr. Kirk Shepard, MD, Chief Medical Officer added, "Based on the increasing incidence of HPV16-positive head and neck cancer, our goal is to seek the fastest and most cost-effective regulatory pathway to approval. Our goal is to be efficient in providing a well-tolerated treatment without chemotherapy as an option for patients who currently have no effective therapies for this deadly disease. Treatment with PDS0101 for currently enrolled patients in our VERSATILE-003 Phase 3 trial will continue during the temporary pause of the trial."

About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy’s impact on patients who are either naive to or refractory to immune checkpoint inhibitors. The full data set from VERSATILE-002 is mature and expected to be submitted for publication later this year.

(Press release, PDS Biotechnology, OCT 29, 2025, View Source [SID1234657111])

On October 29, 2025 NEC reported consolidated Financial Results for the Six-month Period Ended September 30, 2025.

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(Press release, NEC, OCT 29, 2025, View Source [SID1234661702])

On October 29, 2025 Recursion Pharmaceuticals, Inc. (the "Company" or "Recursion") reported the exercise of the option by Roche (as defined below) for a Microglia Map—a first-of-its-kind whole genome map of the brain’s immune cells—generated by Recursion under the Collaboration and License Agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd (collectively "Roche") dated December 5, 2021 (the "Agreement"). Pursuant to the terms of the Agreement, Roche will pay to the Company an Acceptance Fee of $30 million.

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(Press release, Recursion Pharmaceuticals, OCT 29, 2025, View Source [SID1234657113])

On October 29, 2025 GlaxoSmithKline reported strong third quarter performance and upgrades 2025 guidance (Press release, GlaxoSmithKline, OCT 29, 2025, View Source [SID1234659533]).

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