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Galmed Announces Top-line Results in Oncology MoA Studies: A 3-drug combination of Aramchol, Stivarga® and Metformin Significantly Enhanced GI Tumor Cells, Killing In-vivo and In-vitro

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])

Circio issues invitation to R&D and corporate update webcast on 24 November 2025

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

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

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

On November 17, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported the completion of the submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), advanced breast cancer ("ABC"). The NDA was submitted under the FDA’s Real-Time Oncology Review ("RTOR") program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.

"This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "We look forward to working with the FDA during the NDA review process. We believe the unprecedented efficacy results and overall safety profile of the gedatolisib regimens are potentially practice changing for patients with HR+/HER2- advanced breast cancer."

The NDA submission is based on the positive clinical results for the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial. The efficacy results established several new milestones in the history of drug development for HR+/HER2- ABC. The gedatolisib-triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio of 0.24. The median progression-free survival ("PFS") was 9.3 months with the gedatolisib-triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib-doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib-doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

Gedatolisib

Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR ("PAM") inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.1,2,3 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.2 Inhibition of only a single PAM component results in cross-activation of the uninhibited components, which limits the suppression of PAM pathway activity. Gedatolisib’s comprehensive PAM pathway inhibition enables full suppression of the PAM pathway by minimizing the adaptive cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated comparable potency and cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

About RTOR

The FDA established the RTOR program to facilitate a more efficient review process for drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. To be considered for RTOR, submissions should demonstrate the following: 1) clinical evidence from adequate and well-controlled investigation that indicates the drug may demonstrate substantial improvement on a clinically relevant endpoint over available therapies; 2) easily interpreted clinical trial endpoints; and 3) no aspect of the submission is likely to require a longer review time. Additional information about RTOR can be found at: View Source

(Press release, Celcuity, NOV 17, 2025, View Source [SID1234660015])

BioLineRx Announces Receipt of USPTO Notice of Allowance for Key Patent Covering GLIX1 for Treating a Broad Range of Cancer Types

On November 17, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a key patent, entitled, ‘Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies’ (Pat. Appl. Ser. No. 18/602,969), which covers the use of GLIX1 for treating cancer types in which cytidine deaminase (CDA) is not over-expressed beyond a specific threshold. Corresponding patent applications are pending worldwide. The patent further broadens and strengthens GLIX1’s patent protection for the treatment of cancer until 2040, with a possible patent-term extension of up to five years.

It is estimated that over 90% of all cancers do not overexpress CDA beyond the specific threshold, reflecting the importance of this additional intellectual property as BioLineRx expands development of GLIX1 beyond glioblastoma, its initial indication, into other cancer types, once safety and dosing in glioblastoma are established.

"This Notice of Allowance from the USPTO is a critical addition to GLIX1’s intellectual property estate, as it protects our opportunity to evaluate this exciting molecule across the majority of cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx. "As we prepare to initiate a first-in-human study of GLIX1 in patients with glioblastoma in the first quarter of 2026, we are in parallel advancing pre-clinical studies in other cancer models. We believe GLIX1, with its unique mechanism of action that targets the DNA damage response in cancer cells, has the potential to offer new hope to patients suffering from a broad range of difficult-to-treat cancers, and we are eager to commence clinical trials early next year."

GLIX1 is covered by a comprehensive portfolio of patents that are both issued and pending. In addition to the allowed U.S. patent referenced above and corresponding patents issued and pending worldwide, GLIX1 is covered by additional issued or pending patents, which broaden the coverage for its use in treating cancer as both monotherapy and in combination with established anti-cancer agents:

GLIX1 for use in treating cancer of the central nervous system, such as glioblastoma, is covered by patents issued in the US, Europe and 13 other countries. The patents are valid until at least 2040 (with a possible patent term extension of up to five years).
GLIX1, in combination with PARP inhibitors, for use in treating homologous recombination (HR) proficient cancers, which represent the majority of cancers, is covered by a pending international patent application. Corresponding national-phase patents, if granted, will be valid until at least 2044 (with a possible patent term extension of up to five years).

(Press release, BioLineRx, NOV 17, 2025, View Source [SID1234660014])

Artios Announces Oversubscribed $115 Million Series D Financing to Accelerate Clinical Programs in Indications of High Unmet Need

On November 17, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported the successful close of an oversubscribed $115 million Series D financing. The round was co-led by founding investor SV Health Investors and new investor RA Capital Management, with participation from new investor Janus Henderson Investors and broad support from Artios’ existing investors.

The Series D proceeds will expand the clinical evaluation of Artios’ lead program, alnodesertib, to enroll additional ATM-negative1 patients in each of second-line pancreatic cancer and third-line colorectal cancer, for which the program was recently granted U.S. FDA Fast Track Designation. At the AACR (Free AACR Whitepaper) meeting in April 2025, Artios reported that alnodesertib, in combination with low-dose irinotecan, demonstrated a 50% confirmed overall response rate in patients with ATM-negative solid tumors at the recommended Phase 2 dose in the STELLA Phase 1/2a trial. There are currently no approved therapies specifically for patients whose tumors harbor ATM-deficiency, a population where alnodesertib has demonstrated durable responses across eight different solid tumors.

The proceeds from the financing will also be used to initiate a Phase 2 randomized clinical trial for Artios’ second potential first-in-class candidate, ART6043, in patients with BRCA-mutant HER2-negative breast cancer who are eligible to receive a PARP inhibitor. The DNA polymerase Theta (Polθ) inhibitor, ART6043, demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals in data from a Phase 1/2a study presented at the ESMO (Free ESMO Whitepaper) Congress in September 2025. The company is also advancing a first-in-class and highly differentiated DDR inhibitor-Antibody Drug Conjugate (DDRi-ADC) program and expects to name a lead candidate in Q1 2026.

"This Series D accelerates our potential path to registration for both alnodesertib and ART6043, broadening development for the next generation of DNA damage response (DDR) therapeutics to indications among the highest of unmet need across pancreatic, colorectal, and breast cancers, where median survival is often measured in months," said Mike Andriole, Chief Executive Officer of Artios. "As we address these indications and prepare for others, I would like to thank our existing investors, led by SV Health, for their ongoing support, and also our new investors, RA Capital Management and Janus Henderson Investors, for joining our mission to bring these potential medicines to patients as quickly as possible."

Nikola Trbovic, Managing Partner, SV Health Investors, added, "We are thrilled to have supported Artios’ evolution, from an early-stage DDR pioneer when we founded the company to the established company it has become, distinguished by a promising and differentiated pipeline. We look forward to continuing to do so as it deploys the Series D proceeds to drive late-stage development of alnodesertib as well as its pipeline. This financing, and the recent appointment of Mike Andriole as CEO, are exciting steps in Artios’ continued growth and its transition toward becoming a commercially oriented organization."

Jake Simson, Partner, RA Capital Management, commented, "We are excited to co-lead this financing round to advance the next generation of DNA damage response therapeutics. Artios’ differentiated clinical programs, alnodesertib and ART6043, together have the potential to meaningfully expand the impact of DDR-targeted therapies. The rate and durability of responses observed to date for alnodesertib across a range of solid tumors and the early clinical results with ART6043 underscore the strength of Artios’ approach and ability to deliver novel, potentially first-in-class treatments for patients while building significant long-term value."

The investors who supported the Series D round include Andera Partners, Avidity Partners, EQT Life Sciences, Invus, IP Group plc, Janus Henderson Investors, M Ventures, Novartis Venture Fund, Omega Funds, Pfizer Ventures, Piper Heartland, RA Capital Management, Sofinnova Partners, Schroders Capital, and SV Health Investors.

(Press release, Artios Pharma, NOV 17, 2025, View Source [SID1234660013])