On November 17, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering a novel cancer therapy, reported that the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2 inhibitor.

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This milestone was achieved at START Madrid/Fundación Jiménez Díaz University Hospital, under the supervision of Dr. Victor Moreno, Director of Clinical Research and Principal Investigator. Dr. Moreno commented: "I am pleased that our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited, and we look forward to continuing collaborating with One-carbon Therapeutics."

"Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies," said Ana Slipicevic, Chief Executive Officer of One-carbon Therapeutics. "TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible."

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and a dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway – TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells, while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first in human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, NOV 17, 2025, View Source [SID1234661124])

On November 17, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA expression technology for gene and cell therapy, reported an invitation to a live webcast at 10:00am CET on Monday 24 November 2025.

In the webcast, CTO Dr. Thomas B Hansen will present Circio´s latest in vitro and in vivo results on the circVec circular RNA expression platform. Recent findings include design and testing of novel circVec constructs and extended in vivo screening and validation of circVec for AAV gene therapy.

CEO Dr. Erik D Wiklund will provide a general corporate and strategy update.

Presenters:
CEO Dr. Erik Digman Wiklund
CTO Dr. Thomas Birkballe Hansen

Time: 10:00 CET on 24 November 2025

Click here to access Teams webcast
Meeting ID: 366 918 860 415 63
Passcode: Kn2Pq9pM

Questions can be submitted in advance by email to Erik D Wiklund: [email protected] or directly in the live webcast

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(Press release, Circio, NOV 17, 2025, View Source [SID1234660016])

On November 17, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer reported that a podium presentation highlighting INTASYL siRNA Drug Technology will be held at the Advanced Therapies USA 2025 Congress in Philadelphia, PA at the Pennsylvania Convention Center from November 18-19, 2025.

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Podium Presentation Details are as follows:

Title: INTASYL Synthesized siRNA Drug Technology
Down-regulating Gene Expression
Presenting Author: Melissa Maxwell, M.S.
Date: November 18, 2025
Location: Innovation Showcase (Track 2, Seminar Theatre)
Time: 1:15 PM EDT

"The INTASYL siRNA technology represents a promising approach to enhance cancer treatment." said Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals. "Further the INTASYL compound PH-762 may fulfill a medical need for a non-surgical treatment option for patients with cutaneous carcinomas."

(Press release, Phio Pharmaceuticals, NOV 17, 2025, View Source [SID1234660032])

On November 17, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported it will host a virtual Research and Development (R&D) Event from 11:00 am – 1:45 pm ET on Friday, December 5, 2025.

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Candel’s R&D Day will include presentations and panel discussions from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event will provide an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline. Click here to register for the event.

The R&D Day will include the following presentations:

Introduction to Candel Therapeutics:

Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO

Panel Discussion: Immuno-oncology: The next wave of innovation

Panelists:

James P. Allison, PhD, Nobel Laureate, Regental Professor and Chair of Immunology, and Founding Director of Scientific Programs for the James P. Allison Institute at the University of Texas MD Anderson Cancer Center

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy and Director, Center for Cellular Immunotherapies and Parker Institute for Cancer Therapy, Perelman School of Medicine, University of Pennsylvania

Padmanee Sharma, MD, PhD, Professor of Genitourinary Medical Oncology and Immunology, and Director of Scientific Programs for the James P. Allison Institute at the University of Texas MD Anderson Cancer Center

Moderator: Yigal Nochomovitz, PhD, Citi Group

CAN-2409 for newly diagnosed localized prostate cancer

Glen Gejerman, MD, Co-chief of Urologic Oncology, Hackensack University Medical Center

Philip Kantoff, MD, Former Chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, CEO, Convergent Therapeutics

Garrett Nichols, MD, MS, Candel’s Chief Medical Officer

Ron Tutrone, MD, National Director of Clinical Research, United Urology

Moderator: Oliver McCammon, LifeSci Capital

CAN2409: Roadmap to Biologics License Application (BLA)

Sue Stewart, JD, Candel’s Chief Regulatory Officer

Seshu Tyagarajan, PhD, Candel’s Chief Technical and Development Officer

Moderator: Andres Maldonado, PhD, HC Wainwright & Co.

CAN-2409: Pre-commercialization roadmap

Jonathan Mitchell, MSc, Partner, Globe Life Sciences

Jacqueline Poot, President, IDEA Pharma

Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and CEO

Moderator: Andres Maldonado, PhD, HC Wainwright & Co.

CAN-2409 for immune checkpoint inhibitor refractory non-small cell lung cancer

Panelists:

Charu Aggarwal, MD, Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania

Roy Herbst, MD, PhD, Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology, Yale Cancer Center

Dan Sterman, MD, Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery, NYU Langone Health

Moderator: John Newman, PhD, Canaccord Genuity

CAN-3110 for recurrent glioblastoma

Francesca Barone, MD, PhD, Candel’s Chief Scientific Officer

Henry Brem, MD, Professor of Neurosurgery, Johns Hopkins University

Moderator: Kemp Dolliver, Brookline Capital Markets

Registration for this virtual event and access to the live webcast and subsequent replay will be accessible under "Events and Presentations" on the Investors page of the Company’s website at www.candeltx.com or by clicking here.

About CAN-2409

CAN-2409 (aglatimagene besadenovec), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with CAN-2409 in clinical trials with a favorable tolerability profile to date, supporting the potential for combination with standard of care, when indicated.

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where CAN-3110 was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation.

(Press release, Candel Therapeutics, NOV 17, 2025, View Source [SID1234660033])

On November 17, 2025 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, cardiometabolic diseases and GI oncological therapeutics, reported results from its joint research with Virginia Commonwealth University (VCU) evaluating Aramchol’s effect on overcoming drug resistance in gastrointestinal (GI) cancers. The collaboration is based on breakthrough findings published in Nature Communications linking Aramchol to overcome cancer drug resistance.

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Previously in May 2025, Galmed announced that Aramchol significantly enhances Bayer’s regorafenib effect in GI cancer models to kill GI tumor cells. In that study, Aramchol enhanced both flux and autolysosome formation caused by Regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities. Today’s announced top line results include new data regarding the synergetic effects of Aramchol and Stivarga with Metformin. In this latest study, Aramchol demonstrated the mechanism of action of Aramchol’s anti-tumor abilities, alone or when combined with the mutli-kinase inhibitor regorafenib and the type 2 diabetes drug, Metformin, suggesting a synergistic effect and potential for fixed dose combination for treatment.

Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Stivarga (regorafenib) is indicated as standard-of-care third line treatment in metastatic colorectal cancer (CRC), as well as advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST), and hepatocellular carcinoma. Monoclonal antibodies (MABs), such as atezolizumab & bevacizumab, are the first-line therapy for these patients. However, it is estimated that since around 75% of patients develop resistance or intolerance to MABs and because of their high cost, the cost effectiveness is limited. Stivarga is Bayer’s top selling cancer drug, which generated €458 million (~$500 million) in the first nine months of 2022, up 28% from 2021. The main patent protection for regorafenib is expected to expire in August 2028 in Europe and July 2032 in the U.S., potentially resulting in generic versions of regorafenib becoming available, which could significantly affect Bayer’s market share. Based on the top-line results, a fixed dose combination with Aramchol has shown that such combination could potentially become a life-cycle IP strategy for regorafenib to help delay the generic competition." Mr. Baharaff continued "We are looking forward to initiating our Phase 1b study at VCU Massey Comprehensive Cancer Center, which is expected to commence in early 2026. This Phase 1b study will also serve as a proof-of-concept on Aramchol’s efficacy in an oncology clinical setting. Positive findings could lay the groundwork for subsequent accelerated clinical development of Aramchol in key three GI cancers, which if successful, could potentially expand Galmed’s pipeline and create value for investors and stakeholders."

(Press release, Galmed Pharmaceuticals, NOV 17, 2025, View Source,-Stivarga-R-and-Metformin-Significantly-Enhanced-GI-Tumor-Cells,-Killing-In-vivo-and-In-vitro [SID1234660018])