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.

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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])

On November 17, 2025 Merus N.V. (Nasdaq: MRUS) ("Merus"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), and Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme"), a leader in subcutaneous drug delivery solutions, reported they have entered into a global non-exclusive collaboration and license agreement. Under the collaboration, Merus has licensed Halozyme’s ENHANZE drug delivery technology, for the development and potential commercialization of subcutaneous administration of petosemtamab, an EGFR x LGR5 bispecific antibody.

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"Petosemtamab continues to show encouraging results in the clinical studies across numerous solid tumor cancers and has the potential to become a first and best in class treatment in head and neck cancer and beyond. We are proud to collaborate with Halozyme and look forward to working closely with their team on a subcutaneous administration," said Peter Silverman, Chief Operating Officer, General Counsel of Merus.

"We are excited to collaborate with Merus to advance treatment options for patients with r/m HNSCC and other potential indications," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "This collaboration represents a new opportunity for our ENHANZE technology to improve treatment efficiency and enhance the patient treatment experience. Together, we aim to accelerate innovation for patients and healthcare providers."

Under the terms of the agreement, Merus will make an upfront payment to Halozyme, and potential future milestone payments related to commercial and sales attainment, if approved. Halozyme will also be entitled to up to low-mid single digit royalties on net sales of petosemtamab formulated with the ENHANZE technology during the royalty term.

(Press release, Merus, NOV 17, 2025, View Source [SID1234660030])

On November 17, 2025 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, reported that the first patient has been dosed in its ANK-101-004 clinical trial (NCT07027514). This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%.

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"While there has been considerable progress in the treatment of lung cancer many patients do not respond to current approaches", said Thomas Marron, MD, PhD, Director of the Early Phase Trials Unit at the Tisch Cancer Institute at Mount Sinai and Chief Medical Officer of OCCAM Immune and the principal investigator of the study. "The potential use of anchored IL-12 to drive better responses without adding appreciable toxicity could be an important advance for patients."

"Tolododekin alfa has already demonstrated objective responses as a single agent in patients with anti-PD-1-refractory cancers in phase 1 trials", stated Howard L. Kaufman, MD. CEO at Ankyra Therapeutics, "and now we have an opportunity to test tolododekin in patients with advanced lung cancer." Ankyra is working with OCCAM Immune at Mount Sinai in support of Ankyra the LANTERN clinical trial, which is evaluating ANK-101 in combination with PD-1 blockade in patients with first- and second-line NSCLC. Through state-of-the-art immune profiling, OCCAM Immune aims to generate a comprehensive immune atlas to correlate immune modulation with therapeutic efficacy and disease progression, advance biomarker discovery and deepen mechanistic insights into Ankyra’s novel therapeutic approach.

The ANK-101-004 (LANTERN) trial will be conducted at several institutions, including, Icahn School of Medicine at Mount Sinai, Roswell Park Cancer Institute, Mayo Clinic, Moffitt Cancer Center, The University of Chicago, Community Health Network, The University of Miami Sylvester Comprehensive Cancer Center, Karmanos Cancer Institute, FirstHealth of the Carolinas, and OSF Saint Francis Medical Center with additional sites expected as well.

About Tolododekin alfa (ANK-101)

Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

(Press release, Ankyra Therapeutics, NOV 17, 2025, View Source [SID1234660046])

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.

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"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])

On November 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel treatments for recurrent and metastatic cancer, reported an update on corporate progress and reported financial results for the first quarter ended September 30, 2025 (Year end June 30).

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Corporate and R&D Highlights

Advancing PRP Toward Phase 1b First-in-Human Trial (2026)

Propanc continues to advance its lead candidate, PRP, toward a world-first Phase 1b clinical study in 30–40 patients with advanced solid tumors at the Peter Mac Cancer Center in Melbourne. GMP manufacturing scale-up, analytical method validation, and preparation of the Investigator’s Brochure and Clinical Trial Application are underway. Purification processes have been successfully scaled, delivering >95% purity to pharmaceutical standards. Two related patents are in drafting.

Progressing Rec-PRP Synthetic Program

Rec-PRP, a fully synthetic recombinant version of PRP designed for improved stability and global scalability, is undergoing biological validation against the bovine-derived formulation. Supporting research has identified methods enabling large-scale production, with patent drafting in progress. Rec-PRP will enter formal preclinical development following potency evaluation.

POP1 Joint Research Program Extension

Propanc is negotiating a 12-month extension with the Universities of Jaén and Granada to expand the POP1 research program. Recent findings show PRP significantly reduces tumorigenicity in Gemcitabine-resistant pancreatic cancer and modulates malignant cells toward a less aggressive phenotype. Additional patents are being prepared based on these results.

Corporate and Financial Updates

Nasdaq Listing & Public Offering

The Company closed an underwritten public offering of 1,000,000 shares at $4.00 per share, raising gross proceeds of $4 million. Propanc’s common stock began trading on the Nasdaq Capital Market on August 15.

$100 Million Private Placement Facility

Propanc entered into a private placement agreement for up to $100 million to accelerate clinical development. The Company received an initial $1 million investment upon issuance of 100 shares of Series C Convertible Preferred Stock.

Q1 Financial Summary (Quarter Ended September 30, 2025)

Total current assets: $17 million
Total current liabilities reduced by $2 million
Net cash from financing activities: $2.53 million
Quarter-end cash: $600,000
$1 million initial tranche from the Series C facility subsequently received
The Company expects the financing facility to support planned R&D activities, including advancement of PRP and Rec-PRP.

Management Commentary

"Our first quarter delivered meaningful progress across clinical, financial, and strategic initiatives," said James Nathanielsz, CEO of Propanc. "We are focused on initiating the Phase 1b PRP clinical trial, advancing Rec-PRP into preclinical development, and expanding our IP portfolio. With our recent Nasdaq uplisting and long-term financing facility, we are well-positioned to accelerate commercialization of our proenzyme technology."

(Press release, Propanc, NOV 17, 2025, View Source [SID1234660031])