On November 20, 2025 Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF), referred to as "Amplia" or "the Company," reported it has received positive feedback from the US Food and Drug Administration (FDA) in response to questions posed by the Company as part of a recent Type D meeting.

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The Company received a positive response to the Type D questions around the dose optimisation strategy for narmafotinib in the proposed registration-enabling Phase 2b/3 trial which will investigate the combination of the Company’s lead compound, narmafotinib, in combination with gemcitabine and Abraxane in pancreatic cancer. The FDA’s response gives confidence in meeting current projected timelines for the Phase 2b/3 study planned to commence in late 2026. The full protocol will now be prepared for submission for FDA comment in H1 2026.

Dr Chris Burns, CEO and Managing Director of Amplia, commented, "FDA’s response supports the dose comparison design of the Phase 2b portion of this trial prior to the pivotal Phase 3 stage. We see this as a positive outcome as the changes proposed will have minimal impact to the trial timeline. This feedback also allows us to better plan the trial, and a full protocol will now be drafted for FDA comment in H1 2026."

A Type D meeting is a formal interaction with the FDA that allows companies to obtain focused feedback on specific regulatory questions outside of a standard review cycle.

(Press release, Amplia Therapeutics, NOV 20, 2025, View Source [SID1234660097])

On November 19, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company pioneering next-generation antibody-drug conjugate ("ADC"), reported a major step forward in the fight against cancer that goes beyond the ADCs current limitations.

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Following successful presentations and meetings at the World ADC Conference in San Diego with ADC companies as well as with industry leaders and pioneers at CPHI in Frankfurt, Defence is moving forward with the strategy to become a supplier of its Accum platform technology to ADC companies struggling with dosing and toxicity as well as to improve the drug delivery precision to cancer cells more effectively for the benefit of cancer patients.

"Many pharmaceuticals and biotech companies have ADCs on the market or in development. A lot of these companies are facing the same challenge, their ADC being toxic for the patients at therapeutic dose. Defence’s Accum technology can universally enhance the potency of any ADCs, reducing their toxicity, while retaining their epitope selectivity and tumor targeting" said Dr. Maxime Parisotto, Chief Scientific Officer at Defence Therapeutics.

Defence has completed studies confirming its ability to enhance ADCs potency. The most recent comparative study, in mouse xenograft models of HER2-positive breast cancer (JIMT-1 cells), demonstrated a ~20-fold higher anti-tumor efficacy with Accum-Kadcyla than Kadcyla alone when administered at the same dose (0.5 mg/kg). The tumor growth significantly halted in the Accum-Kadcyla-treated group, resulting in a consistent and near-complete response in 90% of the mice while Kadcyla alone at the same dose (0.5 mg/kg) had no effective results on inhibiting tumor growth (see November 4, 2025 press release).

Defence is engaging with ADC companies to transform the ADC cancer therapies with its unique proprietary Accum technology platform to be used with any antibodies and on any indications. Defence’s technology and team are in place to deliver the strategy and build an ADC drug delivery powerhouse.

(Press release, Defence Therapeutics, NOV 19, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-build-adc-drug-delivery-powerhouse-using-its-proprietary-accum-technology [SID1234660863])

On November 19, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3 at 10:50 a.m. ET / 7:50 a.m. PT in Miami, Florida.

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A live webcast of the presentation will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

(Press release, Vir Biotechnology, NOV 19, 2025, View Source [SID1234660106])

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.