On November 19, 2025 Hemispherian AS, a biotechnology company pioneering first-in-class TET2-activating therapeutics for difficult-to-treat cancers, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application titled "Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies" (U.S. Patent Application No. 18/602,969).

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The patent covers the use of Hemispherian’s lead clinical candidate, GLIX1, for the treatment of cancers in which cytidine deaminase (CDA) is not over-expressed beyond a defined threshold — a characteristic found in over 90% of cancers.

This allowance substantially strengthens GLIX1’s intellectual property protection until 2040 with eligibility for up to five additional years. Corresponding applications are pending internationally.

"Receiving this Notice of Allowance is an important milestone and a major validation of GLIX1’s potential," said Zeno Albisser, Chief Executive Officer of Hemispherian. "This patent protects the ability to explore GLIX1 across the vast majority of cancers together with our partner BioLineRx Ltd. (NASDAQ: BLRX). As we advance toward first-in-human studies in glioblastoma, this strengthened IP position enables us to accelerate parallel development strategies in additional tumor types."

GLIX1 is a first-in-class, orally available small molecule designed to modulate the DNA damage response by selectively activating TET2. The molecule has demonstrated potent anti-cancer activity in multiple preclinical models.

A Strengthened Global Patent Estate for GLIX1

The newly allowed U.S. patent expands the extensive international IP portfolio for GLIX1:

GLIX1 for the treatment of cancers of the central nervous system, including glioblastoma, is protected by issued patents in the U.S., Europe, and 13 additional countries. These patents extend to at least 2040 (with potential extension).
GLIX1 in combination with PARP inhibitors for the treatment of homologous recombination (HR)-proficient cancers is protected under a pending international patent application. If granted, national-phase patents will provide protection through 2044, with possible extensions.
Advancing Toward First-in-Human Trials

Hemispherian’s joint venture with BioLineRx is preparing to initiate a Phase 1/2a clinical trial of GLIX1 in glioblastoma in Q1 2026. In parallel, the joint venture continues to advance preclinical studies in additional solid tumor types enabled by this broadened IP protection.

(Press release, Hemispherian, NOV 19, 2025, View Source [SID1234660105])

On November 19, 2025 FYR Bio ("FYR"), a leader in liquid-biopsy precision medicine for neuro-oncology, reported a collaboration with NuvOx Therapeutics, Inc. ("NuvOx") supported by a two-year $1,976,897 Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) (Press release, FYR Bio, NOV 19, 2025, View Source [SID1234660104]). The grant, titled "Liquid Biopsy in Glioblastoma Treated with Chemoradiation and an Oxygen Therapeutic," will enable FYR to integrate its EV-based liquid-biopsy technology into NuvOx’s Phase IIb glioblastoma (GBM) trial.

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Under the award, FYR will apply its EV-Omics (EVO) platform and SPARCs enrichment technology to longitudinal blood samples collected in NuvOx’s RESTORE trial of NanO₂, a radiosensitizer designed to reverse tumor hypoxia. The collaboration will explore extracellular-vesicle (EV) biomarkers that reflect hypoxia biology, correlate with treatment exposure, and help clinicians differentiate pseudoprogression from true progression—a persistent challenge in GBM management.

Built on FYR’s neuro-oncology track record
FYR brings deep expertise in identifying EV-based biomarkers in neuro-oncology. By integrating its EVO Platform into the RESTORE trial, FYR aims to generate multiomic insights that inform patient management and de-risk NuvOx’s program and future trial design.

"Our goal is to help drug development companies de-risk their programs and increase the likelihood of clinical trial success, clarifying who benefits, when, and why," said Katie Havranek, Ph.D., Director of Research & Development at FYR. "Building on FYR’s neuro-oncology experience and prior insights in GBM, this collaboration explores EV biomarkers that may strengthen endpoints, refine patient selection, and guide the next phase of NuvOx’s clinical strategy."

Why this matters for patients and clinical trials

Distinguishing pseudoprogression from true progression: Pseudoprogression after chemoradiation is common in GBM, and can resemble true progression (tumor growth) on MRI. Better differentiation can reduce unnecessary treatment changes and improve patient care.
Addressing tumor hypoxia: Hypoxia drives radioresistance in GBM. NanO₂ is being tested to counteract this biology, while EV-based multiomic readouts may reveal who benefits most and how responses evolve through therapy.
About the collaboration scope
FYR will perform EV-based proteomic and transcriptomic analyses from plasma collected at prespecified timepoints to discover and evaluate hypoxia-related biomarkers and progression-state classifiers. These insights are intended to support NuvOx’s therapeutic development and inform potential future trial design and strategy.

NIH Acknowledgment
Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number 1R44CA298498-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

On November 19, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapies, reported a clinical trial collaboration and supply agreement with Roche to evaluate VET3-TGI, a novel oncolytic immunotherapy developed using KaliVir’s proprietary Vaccinia Enhanced Template (VET) platform, in combination with Roche’s atezolizumab (Tecentriq).

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The collaboration will support the expansion of KaliVir’s ongoing STEALTH-001 (NCT06444815) Phase 1a/1b clinical study evaluating VET3-TGI in patients with advanced or metastatic solid tumors. Under the terms of the agreement, Roche will supply atezolizumab for use in combination with VET3-TGI across multiple dosing cohorts.

VET3-TGI is KaliVir’s lead oncolytic immunotherapy candidate, designed to directly destroy tumor cells while activating a potent immune response through a proprietary payload that includes interleukin-12 (IL-12) and a TGF-β inhibitor. Combining VET3-TGI with atezolizumab aims to amplify immune activation and reshape the tumor microenvironment, with the goal of broadening and deepening clinical benefit for patients with a range of solid tumors.

"This clinical collaboration with Roche allows us to build on the promising clinical and preclinical data by expanding the evaluation of VET3-TGI beyond monotherapy into combination therapy with an established checkpoint inhibitor," said Helena Chaye, CEO of KaliVir Immunotherapeutics. "Partnering with Roche, a global leader in oncology, represents an important step toward advancing innovative therapeutic strategies and exploring the full potential of this novel combination for patients with advanced solid tumors."

About VET3-TGI and the STEALTH-001 Study

VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform, designed to selectively replicate in tumor cells, stimulate local immune responses and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, dose escalation and expansion Phase 1a/1b trial assessing both intratumoral and intravenous administration of VET3-TGI. The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

(Press release, KaliVir Immunotherapeutics, NOV 19, 2025, View Source [SID1234660103])

On November 19, 2025 Purdue Pharma L.P. ("Purdue") reported positive preliminary results from a Phase 1 study of tinostamustine in MGMT promoter-unmethylated (uMGMT) glioblastoma (GBM), a form of aggressive brain cancer with a subset of patients that do not respond or respond poorly to standard-of-care therapy. Tinostamustine was shown to be tolerable at doses of 80 to 100 mg/m², with side effects similar to other anti-neoplastic agents and preliminary signs of efficacy. The results will be shared as a poster at the 2025 Neuro-Oncology Societies Meeting on November 22 in Honolulu, Hawaii. The results were also presented in October at the 2025 European Association for Neuro-Oncology (EANO) meeting.

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Glioblastoma is a fast-growing cancer that occurs in the brain. It is very challenging to treat and there is no cure.1 Most treatments seek to remove or shrink the tumor to help reduce symptoms and prolong survival.1 As many as 15,000 people in the U.S. are diagnosed with glioblastoma each year,2 and nearly 60% of those patients have uMGMT GBM.3

Tinostamustine is an investigational, potential first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action, bifunctional alkylating activity and pan histone deacetylase inhibition (or HDAC inhibition). Tinostamustine has the potential to be a first-line treatment for GBM.

"Newly diagnosed patients with GBM, especially those with uMGMT, experience limited if any survival benefit from current pharmacologic treatment approaches," said Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. "These Phase 1 findings show that tinostamustine can be administered safely following standard chemoradiation. We are encouraged by these results and look forward to advancing tinostamustine through the Phase 2/3 GBM AGILE trial (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), a global adaptive clinical trial for glioblastoma patients led by the Global Coalition for Adaptive Research (GCAR)."

In September 2025, Purdue entered into an agreement to include tinostamustine in GBM AGILE, a pioneering, international adaptive platform trial designed to streamline the clinical trial process and accelerate the evaluation of treatments for glioblastoma. It is led by GCAR, a non-profit corporation and is supported by a global network of clinicians, researchers, biostatisticians, and patient advocacy organizations.

In the current study, the Phase 1, open-label, multicenter dose-escalation trial (NCT05432375) evaluated the safety, tolerability, and preliminary efficacy of tinostamustine following chemoradiation with temozolomide (RT/TMZ), the standard-of-care chemotherapy for GBM. Eligible patients were adults with confirmed uMGMT GBM who had completed RT/TMZ in the past 5 weeks and without disease progression. Tinostamustine was administered as a one-hour intravenous infusion on Day 1 of each 21-day cycle, beginning at 80 mg/m² and escalating to 100 mg/m² using a standard 3+3 design.

Ten patients were enrolled, nine of whom were evaluable for safety and efficacy. The median patient age was 63 years, and most were male. Three patients received tinostamustine at 80 mg/m² without experiencing dose-limiting toxicities (DLTs). Among the six patients treated at 100 mg/m², one experienced a DLT of prolonged low-grade thrombocytopenia. Grade ≥3 treatment-related adverse events were reported in both cohorts, including anemia and hematologic toxicities. Overall, tinostamustine’s side effect profile was considered manageable, and 100 mg/m² was established as the maximum tolerated dose (MTD) per the study protocol.

"Glioblastoma is one of the most devastating cancers, and patients with uMGMT GBM face especially limited treatment options," said Craig Landau, MD, President and CEO, Purdue. "The data generated to date are encouraging and represent a meaningful step forward for tinostamustine, that if successfully developed and ultimately approved by FDA, would provide hope and potential benefit for affected patients and their families. We are encouraged by these preliminary results and committed to advancing innovative science that can transform lives. Tinostamustine reflects the kind of bold innovation we strive for across our pipeline, and we look forward to continuing this important work with urgency and purpose."

While not designed to demonstrate efficacy, exploratory analyses of progression-free and overall survival outcomes showed encouraging signals of clinical activity. Details of these findings will be presented at the scientific meeting. The forthcoming evaluation in the GBM AGILE trial will advance the understanding of tinostamustine’s potential in treating glioblastoma.

This press release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that tinostamustine will successfully complete development or gain FDA approval.

(Press release, Purdue Pharma, NOV 19, 2025, View Source [SID1234660102])

On November 19, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.

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Nuvalent’s NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, and presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.

(Press release, Nuvalent, NOV 19, 2025, View Source [SID1234660101])