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Oncolytics Biotech® to Host Key Opinion Leader Discussion Focusing on Pancreatic and Gastrointestinal Cancers

On July 10, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that it will host a key opinion leader (KOL) webinar to discuss pelareorep in metastatic pancreatic ductal adenocarcinoma (mPDAC) and other gastrointestinal cancers (Press release, Oncolytics Biotech, JUL 10, 2025, View Source [SID1234654333]). The webinar will take place on Tuesday, July 22, 2025, at 1:00 p.m. ET.

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The webinar will feature KOLs Dirk Arnold, M.D., Ph.D. (Asklepios Tumorzentrum Hamburg), Alexander Eggermont, M.D., Ph.D. (University Medical Center Utrecht), Sanjay Goel, M.D., M.S., FASCO (Rutgers Cancer Institute of New Jersey), and Devalingam Mahalingam, M.D., Ph.D. (Northwestern University), who will join the Oncolytics management team to discuss pelareorep’s existing pancreatic clinical data in addition to its potential as an immunotherapy in mPDAC and other gastrointestinal indications.

A live question and answer session will follow a formal presentation and roundtable discussion with the KOLs. To register for the event, please click here.

About the KOLs

Dirk Arnold, M.D., Ph.D., is the Director of Asklepios Tumorzentrum Hamburg and the primary investigator of the GOBLET trial. He has also held positions as Director of the Instituto CUF de Oncologia in Lisbon, Portugal, Director of the Department of Medical Oncology at the University of Freiburg, and Director of the University Cancer Center Hamburg. His research and primary scientific interest focus on gastrointestinal cancers, immunotherapy, and drug development. Dr. Arnold completed his M.D. degree at the Universities of Ulm and Berlin in Germany and specialist instruction at Charité, Humboldt University in Berlin.

Alexander Eggermont, M.D., Ph.D., is a Professor of Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany. Previously, he was the Chief Executive Officer of Gustave Roussy Cancer Campus Grand Paris, France, from 2010 to 2019. Additionally, he was President of both the EORTC (European Organisation for Research and Treatment of Cancer) from 2003 to 2006 and the ECCO (European Cancer Organisation) from 2008 to 2010. He is an author or co-author on more than 900 peer-reviewed papers and has received a number of honors and awards, including Honorary Professor of Oncology "Joseph Maisin Chair" at the Catholic University of Louvain, Belgium, the German Cancer Aid Award in 2019, and the status of Chevalier of the Légion d’Honneur by the French Ministry of Foreign Affairs.

Sanjay Goel, M.D., M.S., FASCO, is an attending physician and a Professor of Medicine at Robert Wood Johnson Medical School. He serves as the Director of Phase I Therapeutics at Rutgers Cancer Institute. He has an interest in drug development of anti-cancer agents, and biomarkers of drug response, particularly in solid tumors and colorectal cancer. His work also includes the outcomes of health in minority patients and health disparities. Dr. Goel has been the author or co-author on over 150 research publications and owns a patent in EGFR-targeted therapy.

He has been the recipient of the Advanced Clinical Research Award (ACRA) in colorectal cancer by the Conquer Cancer Foundation (CCF), of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and has been funded by the National Institutes of Health. He is an active ASCO (Free ASCO Whitepaper) volunteer currently serving on the ASCO (Free ASCO Whitepaper) SEP Item Writing Task Force. He has also served as the track leader of the Scientific Program Committee in the "Developmental Therapeutics and Translational Research – Immunotherapy" track of ASCO (Free ASCO Whitepaper). He has been a grant reviewer on several NIH study sections and on the ASCO (Free ASCO Whitepaper) CCF Grant Review Committee. He has been an invited speaker at several national and international conferences.

Devalingam Mahalingam, M.D., Ph.D., is a faculty member at the Robert H. Lurie Comprehensive Cancer Center, Northwestern University (LCC). He serves as the Director of the Clinical Trials Office (CTO) and the Director of the Developmental Therapeutics (DT) program. His clinical research interests and expertise are designing and executing early phase clinical studies utilizing novel therapeutic agents, incorporating precision oncology and developing these targets within clinical studies for gastrointestinal cancers. He has worked on a number of agents (including oncolytic viruses and GSK3 beta inhibitors) from pre-clinical development to late phase studies. He earned his M.D. and Ph.D. from the National University of Ireland, Galway, clinical training at the Royal College of Physicians Ireland, and completed his fellowship at the University of Texas Health Science Center San Antonio in 2009. He has served as Principal Investigator on approximately 50 clinical trials and authored over 120 manuscripts.

17th Partial Response Confirmed in ACCENT Pancreatic Cancer Trial

On July 10, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that an additional confirmed partial response (PR) has been recorded in the Company’s ongoing ACCENT clinical trial in pancreatic cancer (Press release, Amplia Therapeutics, JUL 10, 2025, View Source;v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6 [SID1234654332]). The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane.

The additional partial response brings the objective response rate to 31%, namely 17 out of 55 patients enrolled in the trial. This compares very favourably to chemotherapy alone where a 23% response rate was reported in the benchmark MPACT study1.

A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected.

Amplia CEO and MD Dr Chris Burns commented: "We are excited to announce another confirmed partial response in the ongoing ACCENT trial. This latest PR brings the response rate for the ACCENT trial to 31%, considerably better than the 23% reported for the benchmark study of chemotherapy alone. Importantly, our study is still ongoing with 20 patients currently on study."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over- expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.

European Commission Approves TEVIMBRA® in Combination with Chemotherapy as a First-Line Treatment for Nasopharyngeal Carcinoma

On July 10, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission has approved TEVIMBRA (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy (Press release, BeOne Medicines, JUL 10, 2025, View Source [SID1234654331]). Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose.1

"The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease," said Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. "Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care."

The approval in NPC is based on results of RATIONALE-309 (NCT03924986), a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naïve patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm.

An updated analysis with an additional 12 months of follow-up showed efficacy results consistent with the interim analysis. Clinically meaningful and sustained improvement in overall survival (OS) was observed, with a median OS of 45.3 months for TEVIMBRA plus chemotherapy compared to 31.8 months for placebo plus chemotherapy.

TEVIMBRA plus chemotherapy was generally well tolerated, and no new safety signals were identified. Pooled safety data included over 3,900 patients who received TEVIMBRA, either as monotherapy (n=1,952) or in combination with chemotherapy (n=1,950), at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 10%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and thrombocytopenia.

"Following our recent EU approval of TEVIMBRA for extensive-stage small cell lung cancer, this new authorization in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumors," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world."

TEVIMBRA was previously approved in the EU as a first-line treatment for eligible patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings.

About Nasopharyngeal Cancer (NPC)

Nasopharyngeal cancer, also known as nasopharyngeal carcinoma, is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage that connects the nose to the lungs.2 NPC, which can be categorized into different pathological subtypes (keratinizing squamous, non-keratinizing, and basaloid squamous)3, is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging.4 In 2020, NPC accounted for approximately 133,000 new cancer cases and 80,000 deaths per year globally and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia.5 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%.6

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global audience. Product availability and approved indications vary by country. Please refer to local prescribing information for complete details.

Plus Therapeutics Announces Two CNSide Presentations at the Upcoming SNO/ASCO CNS Metastases Conference

On July 10, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that its wholly-owned subsidiary, CNSide Diagnostics, LLC ("CNSide") will be showcasing two presentations at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD (Press release, Plus Therapeutics, JUL 10, 2025, View Source [SID1234654330]).

The CNSide data highlights its ability to quantify tumor cells and deliver actionable insights," said Michael Rosol, Ph.D., Plus Therapeutics’ Chief Development Officer. "The diagnostic assay is an exciting advancement for enhancing CNS metastases management and driving therapies like REYOBIQ in our ReSPECT-LM dose optimization trial."

Presentations:

Title CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (BIOM-04), (FORESEE Study, NCT05414123)

Presenter
Priya Kumthekar, M.D.

Date/Time Thursday, August 14, 2025, 7:15 – 9:00 p.m. ET

Location Grand Ballroom VI

Title The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor, (BIOM-03)

Presenter
Priya Kumthekar, M.D.

Date/Time Friday, August 15, 2025, 3:25 – 4:50 p.m. ET

Location Grand Ballroom I-V

Cogent Biosciences Announces Closing of Upsized Public Offering of Shares of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 10, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the closing of its previously announced upsized underwritten public offering of 25,555,556 shares of its common stock, which includes 3,333,333 shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering (Press release, Cogent Biosciences, JUL 10, 2025, View Source [SID1234654328]). The public offering price was $9.00 per share. The aggregate gross proceeds to Cogent from this offering were approximately $230 million, including proceeds from the exercise in full by the underwriters of the option to purchase additional shares, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were sold by Cogent.

Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities acted as joint book-running managers for the offering. LifeSci Capital also acted as lead manager for the offering.

The shares described above were offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering were filed with the SEC on July 9, 2025 and may be obtained from the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.