On October 7, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that the first patient has enrolled in PRISM-TAMP, "PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP," an investigator-initiated trial (IIT) sponsored by the University of Vermont (UVM). One week after the IIT began, a second patient is also progressing toward TAMP treatment.

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PRISM-TAMP is evaluating the approved chemotherapy gemcitabine delivered through RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform, enabled by RenovoCath, as neoadjuvant treatment before surgery in patients with borderline Pancreatic Ductal Adenocarcinoma (PDAC). PRISM-TAMP is the first RenovoRx supported IIT to advance to patient enrollment. UVM plans to enroll approximately 10 patients and is registered on ClinicalTrials.gov (NCT07477418). The primary focus of PRISM-TAMP is to assess PDAC tumor regression, the impact on intraoperative surgical margins following neoadjuvant (pre-surgical) treatment, and overall safety and tolerability.

In borderline resectable pancreatic cancer, the tumor involves nearby blood vessels to a degree that can make complete surgical removal difficult. Patients typically receive chemotherapy, with or without radiation, before surgery, and typically receive such treatment systemically, rather than administered locally near the tumor site as TAMP is designed to do.

"For patients with borderline resectable pancreatic cancer, treatment before surgery can influence both whether surgery is possible and how completely the tumor can be removed," said Conor O’Neill, MD, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, and principal investigator of PRISM-TAMP. "PRISM-TAMP will assess whether delivering chemotherapy directly near the tumor through TAMP before surgery can improve local therapeutic response and surgical outcomes. We are pleased to have enrolled our first patient in this important study."

"As TAMP becomes more well known in the marketplace, physicians have asked how TAMP could be used in borderline resectable pancreatic cancer and other settings beyond locally advanced pancreatic cancer, which is the focus of our ongoing Phase III clinical trial," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "Enrolling the first PRISM-TAMP patient marks an important step for our IIT program as it moves from concept to clinical execution. These capital-efficient trials enable independent investigators to generate safety and tolerability data of new applications for TAMP, while we remain focused on completing the Phase III TIGeR-PaC trial and reporting topline data in the second half of 2027."

UVM is evaluating RenovoRx’s novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath (known as IAG) within the PRISM-TAMP study.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-H-Universal-IFU.pdf.

(Press release, Renovorx, OCT 7, 2026, View Source [SID1234673271])

On October 7, 2026 Vaccinex, Inc. a clinical-stage biotechnology company pioneering a differentiated approach to treating Cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), reported the publication in Nature Communications of results from an Emory University and Winship Cancer Institute-sponsored pilot study evaluating pepinemab in patients with metastatic melanoma. The publication represents an important milestone in an almost decade-long scientific partnership between Vaccinex and Winship investigators, focused on advancing the understanding of SEMA4D biology and its potential application in cancer immunotherapy. The findings provide new evidence in human cancer supporting Vaccinex’s strategy of targeting SEMA4D to reshape the tumor immune environment and promote conditions that support recognition of cancer cells and a coordinated antitumor immune response that may complement checkpoint inhibitors and other immunotherapies.

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The study evaluated pepinemab in combination with the checkpoint inhibitors nivolumab and/or ipilimumab before surgery in patients with resectable metastatic melanoma. Consistent with its biomarker-driven design, the study focused on measuring treatment-associated changes in tumor immunity. The predefined primary biomarker endpoint was met; the trial was not powered to establish clinical efficacy.

Researchers found that pepinemab-containing regimens were associated with broad changes in the tumor microenvironment consistent with enhanced antitumor immunity. These changes included stronger biomarker signals associated with tumor recognition and antigen presentation, recruitment and activation of immune cells, and the development of highly organized immune structures known as mature lymphoid aggregates.

Importantly, greater abundance of mature lymphoid aggregates was associated with longer recurrence-free survival. This observation provides an encouraging link between the immune remodeling identified in the study and patient outcomes; however, the small biomarker-focused trial was not designed to demonstrate a clinical benefit from pepinemab. Confirmation in larger, randomized studies will be needed.

The publication, "Neoadjuvant pepinemab in combination with nivolumab and/or ipilimumab in resectable metastatic melanoma: a pilot biomarker-driven trial," is the result of a longstanding scientific collaboration between Vaccinex and investigators at Winship Cancer Institute of Emory University led by Michael C. Lowe, MD, MA, Gregory B. Lesinski, PhD, MPH, and Chrystal M. Paulos, PhD with additional contributions from The University of Texas MD Anderson Cancer Center led by Jennifer Wargo, MD, MMSc. The investigator-initiated trial was sponsored by Emory University and Winship Cancer Institute, with Vaccinex providing pepinemab together with scientific and research support. Vaccinex Research leaders included Elizabth Evans, PhD, Senior Vice President Discovery and Translational Medicine, and Crystal Mallow, Senior Research Scientist, who developed novel immunohistochemical methods for this study.

Key Findings

Pepinemab was associated with broad remodeling of the tumor immune environment. SEMA4D blockade was associated with changes across several components of antitumor immunity, including biological programs involved in antigen presentation, immune-cell recruitment and activation, together with changes in myeloid cells that can influence whether the tumor environment suppresses or supports an immune response.

Pepinemab-containing regimens were associated with highly organized immune structures within tumors. Mature lymphoid aggregates contained distinct populations of immune cells arranged in defined regions that enable local immune interactions. Some aggregates displayed features resembling tertiary lymphoid structures (TLS), specialized sites where multiple components of an immune response can come together within or near tumors.

More mature immune structures were associated with longer recurrence-free survival. Patients with greater abundance of mature lymphoid aggregates tended to remain recurrence-free longer. Additional analyses found evidence of expanded T- and B-cell populations within these structures, supporting the concept that they represented sites of active immune responses. Because the trial was designed to study biological effects and included a relatively small number of patients, these clinical associations are exploratory and require confirmation in larger studies.

About the Study

The investigator-sponsored pilot trial (NCT03769155) evaluated pepinemab in combination with nivolumab and/or ipilimumab in patients with resectable metastatic melanoma. Patients received two doses of treatment before planned surgery, allowing investigators to directly examine how the treatments affected the immune environment within subsequently resected tumors.

Thirty-eight patients participated in the study, and neoadjuvant treatment did not prevent or postpone curative-intent surgical resection. No grade 4 or 5 adverse events occurred during treatment before or after surgery.

The trial represents one component of a scientific partnership between Vaccinex and Winship Cancer Institute of Emory University, advancing SEMA4D research from mechanistic studies toward clinical evaluation in cancer. Vaccinex supplied pepinemab and supported multiple aspects of the research program, including scientific and operational oversight, generation and analysis of study data, and development of the scientific publication. Bristol Myers Squibb provided nivolumab and ipilimumab.

Together, these findings provide evidence from human tumors supporting the proposed mechanism of pepinemab and Vaccinex’s strategy of targeting SEMA4D as a means of reshaping the tumor immune environment. By promoting conditions associated with improved antigen presentation, immune-cell recruitment and organized adaptive immunity, SEMA4D blockade may offer a complementary approach to checkpoint inhibition and other cancer immunotherapies. The results support continued evaluation of pepinemab-containing combinations in melanoma and other solid tumors.

Publication

Ruffin, A.T., Mallow, C.L., Olson, B.M. et al. Neoadjuvant pepinemab in combination with nivolumab and/or ipilimumab in resectable metastatic melanoma: a pilot biomarker-driven trial. Nat Commun (2026). View Source

Clinical trial: NCT03769155

About Pepinemab

Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications.

(Press release, Vaccinex, OCT 7, 2026, View Source [SID1234673270])

On October 7, 2026 Rivercell, a Paris-based biotechnology and AI company building its own data infrastructure on how human cells respond to any treatment and training a world model of the cell that can predict those responses, reported a $25 million seed round led by HV. HCVC, Alven and Bpifrance Digital Venture also participated in the round, which will fund the scale-up of Rivercell’s proprietary data generation platform, the expansion of its wet lab in Paris (a lab working with chemicals and biological samples), and the launch of its AI Virtual Cell program. Being indication-agnostic, Rivercell’s world model can drive groundbreaking discovery across any cell behavior that leads to disease because it learns the underlying rules of how human cells respond to drugs and genetic changes, not the features of a single disease.

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Rivercell was started in summer 2025 by CEO Yann Fleureau, the engineer-turned-entrepreneur behind AI company Cardiologs, joined in 2026 by CSO Eric Durand, an AI scientist and former C-Level executive at AI drug discovery unicorn Owkin. Rivercell builds a proprietary platform that generates massive, high-quality pre-training datasets to train its "AI virtual cell" (AIVC) model. AIVC is a world model designed to predict how human cells respond to a drug or genetic change in silico, reducing the overall need for physical wet-lab experiments significantly. Rivercell’s long-term goal is to fundamentally change drug discovery by accelerating and redesigning it. Developing a single drug can take years and be costly, with the industry investing nearly $300 billion in R&D each year.

Realizing this potential depends on data. AlphaFold revolutionized protein structure prediction because it could draw on decades of publicly available protein structure data. Building a comparable model of the cell is a far greater challenge: it requires diverse, multimodal, time-resolved data on how cells respond to perturbations. No such dataset exists at the scale needed today, so Rivercell is creating that foundation. The company generates a large-scale biological dataset and uses it to train its AI virtual cell. Because today’s laboratory instruments were not designed for this application, Rivercell is developing an innovative, purpose-built platform capable of capturing the data at the scale required to pre-train its world model. The company describes this platform as the "GPU for the bio data center" of the future.

"A world model of the cell is the opportunity of the century in medicine. The missing piece is data: how cells change over time and under treatment, seen through multiple lenses and at multiple layers, captured at scale. Building that data engine in Europe is strategic, not only for Rivercell but for the continent’s place in AI and biology," said Yann Fleureau, co-founder and CEO of Rivercell.

Engineer and serial entrepreneur Yann Fleureau previously co-founded and led AI diagnostics company Cardiologs, raising several funding rounds before its nine-figure acquisition by Philips in 2021. Data scientist Eric Durand was director of oncology data science at Novartis and served as Chief Data Science Officer at Owkin before co-founding bio foundation model company Bioptimus, which raised $76 million.

"AI is already rewriting how we understand the chemistry of life, from protein structure to molecular design. The next frontier is predicting how cells behave, and that requires a full-stack approach that combines a novel platform, automated wet labs, and world models. Yann and Eric bring exactly this combination of expertise, and with its footing in both Paris’s AI ecosystem and Basel’s pharma cluster, Rivercell is uniquely positioned to lead it," said Maxi Pethö-Schramm, Principal at HV.

Rivercell is also backed by scientific advisors including Dr. Charlotte Bunne and Prof. Dr. Dr. Fabian Theis and angel investors including founders and executives from Twist Bioscience, DNA Script, Agilent and Abivax/Ipsen.

"AI virtual cells will transform how we understand and engineer biology. Rivercell’s ambition to unite large-scale perturbation experiments with AI simulation is why I’m excited to join its Scientific Advisory Board," said Dr. Charlotte Bunne, Assistant Professor, Artificial Intelligence in Molecular Medicine at EPFL.

"Understanding how cells respond to perturbations, over time rather than in snapshots, is one of the big open problems in biology. Rivercell is tackling it at scale, with both the data and the AI models to match. I’m thrilled to join its Scientific Advisory Board," closed Prof. Fabian Theis, Director of the Computational Health Center at Helmholtz Munich, Scientific Director of Helmholtz AI and Professor of Mathematical Modeling of Biological Systems at the Technical University of Munich.

(Press release, Rivercell, OCT 7, 2026, View Source [SID1234673269])

On October 7, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a pioneering biotechnology company in the field of next-generation precision therapies ("Valerio", or the "Company"), reported an update on its operations and presents its financial results for the half-year ended 30 June 2026.

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"The first half of 2026 marked a decisive milestone in the consolidation of our strategic refocusing and in the transformation of Valerio Therapeutics. The operational launch of InVimmune, the strengthening of our partnerships, the signing of the definitive agreement for the acquisition of Etherna and the governance transition demonstrate our ability to implement our roadmap with determination, consistency and discipline. These complementary advances strengthen our positioning and open up new prospects for therapeutic development. We now have a solid foundation on which to accelerate the development of our targeted RNA delivery platform, deepen scientific and operational synergies within the Group, and advance our proprietary programmes towards key milestones that are likely to create sustainable value for our patients, partners and shareholders," said Gilles Besin, Chief Executive Officer of Valerio Therapeutics.

Consolidation of the group’s strategic refocusing

Valerio Therapeutics has continued the strategic refocus initiated in 2025, aimed at positioning the Company as a specialist in the development of RNA-based precision therapies, with a focus on targeted delivery beyond the liver. This consolidation has resulted in several significant milestones.

The Company launched InVimmune, its subsidiary dedicated to the development of differentiated in vivo cell therapy approaches, with a first indication announced in oncology.

As part of a planned governance transition, Gilles Besin took up his position as Chief Executive Officer of the Company on 1 July 2026, succeeding Julien Miara, to lead this new phase of development focused on RNA-based medicines and targeted delivery.

In addition, the Company’s partnership strategy has been strengthened through the conclusion of key partnerships:

– Valerio has entered into a definitive collaboration agreement and an exclusive global licence, providing for an upfront payment of 740,000 euros and an additional payment of 500,000 US dollars upon the signing of the definitive collaboration and licence agreement on 29 May 2026. It also provides for conditional future payments of up to US$200 million, to which sales royalties may be added,

– Valerio has also entered into a binding term sheet with Abivax SA ("Abivax") setting out the key terms of an exclusive global research and development collaboration1. This term sheet provides for an initial payment of up to 2.4 million euros, supplemented – subject, in particular, to the conclusion of the definitive co-ownership and licence agreement and the achievement of the corresponding milestones – by milestone payments and royalties.

The Company also reached a major milestone with the signing, on 24 August 2026, of a definitive share purchase agreement as part of the acquisition of 100% of the share capital and voting rights of Etherna Immunotherapies NV; the integration of this company brings together, within a single platform, proprietary capabilities in V-Body, active targeting, chemistry and bioconjugation, mRNA and lipid nanoparticle technologies, as well as manufacturing capabilities, within a single platform. The general meeting held on 6 October 2026 approved the capital increase in consideration for contributions in kind and the capital increases by way of set-off against certain claims held by lenders and directors of Etherna. The completion of the transaction is scheduled on 8 October.

In August 2026, the Company carried out a capital increase of c. €40.25 million, achieved through the issue of 68,220,333 new shares at a subscription price of €0.59 per share, supported by its existing shareholders and new investors2.

Financial results for the first half of 2026

Turnover: The Group recorded consolidated turnover of €3,102,000 for the period ending 30 June 2026, compared with €126,000 as at 30 June 2025.
Financial result: The financial result as of 30 June 2026 was a loss of €137 000, compared with a loss of €285 000 as of June 30, 2025.
Consolidated net profit: Consequently, the consolidated net result as of 30 June 2026 was a loss of €2 361 000, compared with a loss of €208 000 as of 30 June 2025.
Cash position: The Group’s balance of cash and cash equivalents as at 30 June 2026 stood at €656,000, compared with €1,053,000 as at 31 December 2025. As of the date of the half-year financial report, based on its current operating plan and expenditure forecasts, and taking into account its cash and cash equivalents, the Company estimates that it has sufficient resources to finance its operations and capital expenditure for at least 12 months.
Shareholders General Meeting of 6 October 2026

The shareholders general meeting held on 6 October 2026 approved all the resolutions recommended by the Board of Directors.

The results of the votes will be made available on the Company’s website (View Source).

(Press release, Valerio Therapeutics, OCT 7, 2026, View Source [SID1234673268])

On October 7, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the enrollment of the first patients in a new Signatera-guided trial in melanoma (NCT07504796), sponsored by NYU Langone Health.

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The study uses Signatera to guide treatment escalation for patients with advanced or metastatic melanoma, an aggressive form of skin cancer. The current standard of care for these patients is combination immunotherapy until clinical progression. This trial is designed to identify patients who may need earlier intervention by detecting persistent molecular residual disease (MRD) prior to radiographic progression.

After six weeks of first-line treatment (Nivolumab+Relatlimab), patients who are Signatera-positive without radiographic progression will be randomized into one of two different treatment arms: either continuation of first-line treatment until clinical progression; or intensification of first-line treatment with the addition of Ipilimumab. The primary endpoint is progression-free survival.

"This trial takes a more proactive therapeutic approach from the standard of care, which is to treat with immunotherapy until evidence of radiographic progression," said Janice M. Mehnert, M.D., principal investigator of the study. "By using Signatera to identify patients who do not clear ctDNA early in the treatment regimen, we can act sooner to escalate therapies for those who need it as we aim to improve outcomes."

"We are pleased to collaborate with NYU Langone Health on this important trial in melanoma," said Michael Krainock, M.D., Ph.D., MBA, medical director, oncology, Natera. "By integrating Signatera into the trial design, we hope to improve patient selection for therapy escalation – distinguishing those who may be able to continue their current treatment without disease progression from others who need more intensified therapy. If the results are positive, this could be an important step toward changing clinical practice patterns in how we manage melanoma."

(Press release, Natera, OCT 7, 2026, View Source [SID1234673267])