On December 10, 2025 GSK plc (LSE/NYSE: GSK) reported that its B7-H3-targeted antibody-drug conjugate GSK’227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of small-cell lung cancer (SCLC). The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC (ES-SCLC) who were treated with risvutatug rezetecan in the phase I ARTEMIS-001 clinical trial.1

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In the US, SCLC constitutes about 13% of all lung cancers. In 2025, an estimated 29,500 people in the US will be diagnosed with SCLC.2 Of patients with SCLC, 70% have extensive-stage disease, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.3 ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options. The 5-year survival rate is approximately 3%.3 Most patients with ES-SCLC relapse after initial treatment and the median overall survival with standard-of-care treatments for relapsed ES-SCLC is approximately 8 months.4

This designation follows the recent announcement that risvutatug rezetecan was granted ODD from the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, a category of cancer that includes SCLC. It is the fifth regulatory designation for risvutatug rezetecan, exemplifying the potential of this B7-H3-targeted ADC, which is being developed in a range of solid tumours, including lung, prostate and colorectal cancers. Previously, risvutatug rezetecan was granted Priority Medicines (PRIME) Designation by the EMA for relapsed or refractory ES-SCLC and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma granted by the US FDA.5,6,7

About risvutatug rezetecan
Risvutatug rezetecan (GSK5764227) is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of risvutatug rezetecan. GSK’s global phase III trial (NCT07099898) for risvutatug rezetecan in relapsed ES-SCLC began in August 2025.

(Press release, GlaxoSmithKline, DEC 10, 2025, View Source [SID1234661344])

On December 10, 2025 Indivumed reported its partnership with the world-renowned Wilmot Cancer Institute at the University of Rochester Medical Center (URMC). Leveraging Indivumed’s proven approach to standardized tissue and clinical data collection for patient-centric cancer R&D, this collaboration aims to accelerate the development of novel cancer therapeutics for patients with high medical need.

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An integral resource for patient-centric cancer R&D

Indivumed’s innovative platform builds on carefully collected and curated surgical tissue samples and comprehensive clinical data to drive patient-centric cancer research and drug development. URMC’s invaluable role includes the collection and processing of high-quality biosamples and clinical patient data, adhering to Indivumed’s rigorous standard operating procedures (SOPs). A key advantage is minimizing ischemia time to under ten minutes, ensuring sample integrity and quality.

Priority of the joint research efforts is the creation of well-characterized, patient-derived tumor models (PDTMs) from the very same samples. These cell models, including classical cell cultures, spheroids, and organoids, combined with data insights subsequently serve to advance and de-risk the process of identification, validation, ligand screening, and development of pharmaceutical molecular cancer targets.

Hartmut "Hucky" Land, PhD, Deputy Director of the Wilmot Cancer Institute, is looking forward to the collaboration: "We have worked with Indivumed successfully in the past and our familiarity with their tissue and multi-omics data approach will provide an excellent foundation. The new project will create greater opportunities to identify new therapeutics and biomarkers, uncover insights on the right target-patient match for clinical decision-making, and thus help advance cancer care."

Focusing on advanced stages of specific entities

The collaboration initially focuses on advanced stages of solid cancers with a high medical need, such as colorectal (CRC), pancreatic (PDAC), lung, and breast cancer, with the potential to expand to other cancer types in the future. Insights gained through this partnership will advance Indivumed’s ongoing research initiatives and asset development, while offering participating clinicians valuable guidance to inform therapeutic decision-making.

"We are thrilled to deepen our collaboration with URMC, significantly enhancing our ability to identify novel cancer therapeutics in a truly patient-centered approach," says Hartmut Juhl, CEO and founder of Indivumed. "We will develop primary tumor models for the testing of novel compounds against targets which have been identified by our unique AI-powered data analytical capabilities to bring novel therapeutics to patients as fast and precisely as possible."

With this agreement, the University of Rochester Medical Center joins the Indivumed Global Clinical Network, which already includes a sizeable number of renowned hospitals and leading oncology institutes in North America, Europe and Asia. The collaboration builds on the success of previous collaborations with joint research efforts between the two parties, including a recent publication on the discovery of an alternative way to classify distinct types of colon cancer.

(Press release, Indivumed Therapeutics, DEC 10, 2025, View Source [SID1234661360])

On December 10, 2025 Kazia Therapeutics Limited ("Kazia" or the "Company") reported new data from two presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) providing compelling mechanistic and early clinical evidence supporting the activity of paxalisib, the Company’s brain-penetrant dual PI3K/mTOR inhibitor, across both HER2-positive metastatic breast cancer and triple-negative breast cancer (TNBC).

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The results, originating from advanced liquid biopsy profiling, immune phenotyping, and early clinical readouts, highlight paxalisib’s potential to disrupt highly aggressive circulating tumor cell (CTC) clusters, reverse epigenetically-driven resistance pathways, and reinvigorate exhausted T- and B-cell populations, thereby enhancing responsiveness to immunotherapy.

Paxalisib Disrupted Drivers of Metastasis: Vim+/Snail+/NRF2+ CTC Clusters in HER2+ Disease Ex Vivo

In HER2-positive metastatic breast cancer, a population in which nearly all patients eventually relapse despite HER2-directed therapies, investigators observed that even patients who were radiographically responding continued to harbor substantial burdens of therapy-resistant CTC clusters—a key driver of metastatic spread.

Poster Presentation: PS2-10-02 : Liquid Biopsy Tracking of PI3K–mTOR Residual Disease Signatures in Metastatic HER2+ Breast Cancer

Key findings:

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Paxalisib reduced single CTCs by 42% and CTC clusters by 78% ex vivo, including large clusters (≥5 cells), which are strongly associated with metastatic progression.

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CTC clusters expressed a highly aggressive mesenchymal phenotype marked by Vimentin⁺/Snail⁺/NRF2⁺, which paxalisib significantly disrupted.

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Patients with poor clinical response demonstrated impaired cytotoxic function (reduced Granzyme B and Perforin) and expanded exhausted T-cell populations, while paxalisib treatment activated cytotoxic, interferon, chemokine, and inflammatory pathways in samples from these patients, supporting a more immunologically "hot" tumor environment.

"These findings reveal an important biological gap left by existing HER2+ directed therapies," said Prof. Sudha Rao, QIMR Berghofer. "CTC clusters persist even in responding patients, and paxalisib is the first agent we have observed that can directly dismantle this highly aggressive and clinically relevant compartment."

TNBC Phase 1b Trial: Early Clinical Data from First Patient Show Robust Suppression of CTC Clusters and Reversal of T-Cell Exhaustion

Early longitudinal biomarker data from the first patient treated in the PaxPlus-ABC Phase 1b study (paxalisib + pembrolizumab + chemotherapy) indicate that paxalisib has had measurable biological activity after only a single cycle.

Poster Presentation: PS5-08-04: A phase 1b, multi-centre, open-label, randomized study to evaluate the safety, tolerability, and clinical activity of combining paxalisib with olaparib or pembrolizumab/chemotherapy in patients with advanced breast cancer

Highlights from first patient include:

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Marked reduction in CTC clusters following the first cycle of paxalisib.

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Epigenetic reprogramming of CTCs toward less aggressive phenotypes, confirmed through digital pathology and Nanostring profiling.

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Significant reduction of exhausted CD8 T cells, with revitalization of cytotoxic and antigen-presentation pathways.

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CT imaging has demonstrated overall primary tumor volume reduction from baseline 14mm x 11mm (154mm2) to 12mm x 3 mm (36mm2)

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Notably, a temporary interruption of paxalisib (necessitated by a chemotherapy-related adverse event) resulted in a rapid resurgence of CTC clusters. Resumption of paxalisib after a short 3-week pause restored suppression of CTC clusters, indicating that pembrolizumab alone could not control these metastatic drivers and highlighting paxalisib’s unique mechanistic role.

Pembrolizumab Alone May Not Control CTC Burden; A Mechanistic Opportunity for Paxalisib

Across HER2+ and TNBC ex-vivo datasets, a consistent theme emerges:

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Pembrolizumab monotherapy does not meaningfully reduce CTC burden, and in TNBC, CTC clusters increased when paxalisib was withheld.

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Paxalisib directly targets mesenchymal, metastatic, and epigenetically resistant CTC clusters.

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It also reinvigorates immune effector cells, potentially overcoming the cytotoxic dysfunction and exhaustion that limit checkpoint inhibitor efficacy.

This mechanistic direct suppression of metastasis-initiating cells plus restoration of immune function positions paxalisib as a potentially transformative immunotherapy-enhancing agent.

Expanding Opportunity Across Breast Cancer: HER2+, TNBC, BRCA-Mutated, and Beyond

Because mesenchymal CTC clusters and T-cell exhaustion are shared resistance mechanisms across multiple breast cancer subtypes, paxalisib’s effects are highly relevant beyond TNBC.

Emerging data suggest:

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In HER2+ patients, despite targeted therapy, residual disease persists in the form of aggressive CTC clusters—a new therapeutic window for paxalisib.

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In TNBC, paxalisib’s epigenetic and immunologic effects provide a strong rationale for combination with pembrolizumab, PARP inhibitors, and chemotherapy.

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In BRCA-mutated and homologous recombination–deficient tumors, PI3K/mTOR inhibition may synergize with synthetic lethal strategies such as olaparib.

"Kazia’s recent clinical and translational findings point to a unifying biology across breast cancer subtypes," said Dr. John Friend, CEO of Kazia Therapeutics. "Paxalisib appears capable of disrupting metastatic machinery that is not adequately addressed by current HER2-targeted therapies, checkpoint inhibitors, or chemotherapies. We believe these discoveries meaningfully expand the potential utility of paxalisib beyond our current development programs."

For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795.

(Press release, Kazia Therapeutics, DEC 10, 2025, View Source [SID1234661345])

On December 10, 2025 Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer, reported results from the first independent validation of AidaBreast, a novel multi-omic biosignature developed to predict a woman’s 10-year risk of locoregional recurrence (LRR) and her individualized benefit from adjuvant radiation therapy (RT) following breast-conserving surgery.

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The findings will be presented at the San Antonio Breast Cancer Symposium (SABCS) 2025 by Dr. Bruce Mann, Director of Research at Breast Cancer Trials, Head of Breast Surgical Research at Royal Melbourne Hospital, Professor of Surgery at The University of Melbourne, and Principal Investigator of the study, together with Troy Bremer, PhD, Chief Scientific Officer of PreludeDx.

The validation study, conducted at Royal Melbourne Hospital (RMH) in Australia, evaluated more than 400 women with early-stage HR+ / HER2- invasive breast cancer who underwent breast-conserving surgery and endocrine therapy, with or without radiation therapy. The results confirmed and strengthened PreludeDx’s initial validation:

AidaBreast stratifies women into Low Risk and Elevated Risk groups based on underlying tumor biology.
Within the Elevated Risk group, the test identifies which women are likely to experience significant therapeutic benefit from RT, and which show minimal benefit from RT, despite elevated recurrence risk.
Women in the Low Risk group demonstrated very low 10-year recurrence rates whether or not they received radiation therapy.
"This independent blinded validation confirms the prior results, demonstrating that AidaBreast is prognostic for LRR risk and predictive for RT benefit. The results demonstrated that the test identified patients who are good candidates for the omission of RT and patients who would significantly benefit from radiation therapy," said Dr. Bruce Mann, Principal Investigator of the study. "AidaBreast provides information that cannot be determined from clinicopathology alone and offers a major advance in early-stage invasive breast cancer treatment."

AidaBreast: The First and Only Test Providing Both Prognostic and Predictive Insight for Radiation Therapy

AidaBreast uses multi-omic technology by analyzing RNA and protein expression together with spatial biology, providing a more complete assessment of a patient’s tumor biology.

"AidaBreast provides a new level of clarity for women with early-stage invasive breast cancer," said Dan Forche, President and CEO of PreludeDx. "For the first time, patients and physicians have a tool for Stage I and IIa breast cancer that supports shared treatment decisions, helping women make more confident and informed choices on radiation therapy."

AidaBreast: The Next Generation of Insight for Early-Stage Breast Cancer

AidaBreast assessment of RT benefit is the first in a comprehensive approach for early-stage invasive breast cancer. Future plans include evaluation of endocrine therapy and chemotherapy benefit, enabling a unified, integrated decision-support tool.

"This is the first and only commercially available test developed specifically for RT in Stage I and IIa breast cancer", said Dr. Troy Bremer, CSO. "Prior tests were focused on metastatic risk and chemotherapy benefit. AidaBreast incorporates both RNA and functional proteins that drive tumor biology, giving patients and clinicians the first tool for assessing both recurrence risk and predicting radiation therapy benefit."

Extending the Proven Impact of DCISionRT

AidaBreast builds on PreludeDx’s leadership established with DCISionRT, the widely adopted test that transformed radiation therapy decision-making for women diagnosed with ductal carcinoma in situ (DCIS).

"With AidaBreast, we are bringing the same level of precision and biological insight to early-stage invasive breast cancer," added Forche. "Our goal is to ensure women have the clearest possible understanding of their treatment options so they can make the best decision for their health and quality of life."

About DCISionRT

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. The test provides a Decision Score that identifies a woman’s risk as low, elevated, or residual risk. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed, personalized treatment decisions.

(Press release, PreludeDx, DEC 10, 2025, View Source [SID1234661361])

On December 10, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 727,969 shares of common stock of the Company originally issued in February 2025 at an exercise price of $6.63 per share and 316,360 shares of common stock of the Company originally issued in August 2025 at an exercise price of $6.3219 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-286276) and Form S-3 (File No. 333-290418). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.5 million, before deducting financial advisory fees.

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Roth Capital Partners and Maxim Group LLC are acting as the Company’s financial advisors for this transaction.

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 2,610,823 shares of common stock, at an exercise price of $6.63 per share and will be exercisable upon shareholder approval and for a term of five years from the date of shareholder approval.

The transaction is expected to close on or about December 11, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Moleculin, DEC 10, 2025, View Source [SID1234661346])