BetaGlue Therapeutics expands Clinical Trial in Italy to conduct its clinical study in unresectable locally advanced pancreatic cancer (uLA-PDAC)

On December 1, 2025 BetaGlue Therapeutics ("BetaGlue" or the "Company") a pioneering Italian clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, is proud to announce that the Italian Ministry of Health (MOH) has approved its Clinical Trial Application for YntraDose in the treatment of unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC). This authorization follows the recent Clinical Trial Approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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The clinical study, which is expected to begin enrolling patients in early 2026, with preliminary results expected by the end of the year, is an early feasibility clinical investigation designed to evaluate safety, usability and feasibility of YntraDose administration in patients with unresectable LA-PDAC which remains a significant health concern with limited effective treatment options and a pressing unmet medical need. YntraDose represents an innovative locoregional radiotherapy, utilizing Yttrium-90
microspheres embedded in a quickly polymerizing matrix to deliver targeted radiation directly to solid tumours.

This approach has been designed with the aim to maximize therapeutic efficacy while minimizing damage to surrounding healthy tissue, offering new hope for patients facing unresectable locally advanced pancreatic cancer – one of the most aggressive and difficult-to-treat malignancies. "As an Italian company, deeply committed to advancing cancer care, we are honoured to announce that the Italian Health Authorities have approved our clinical study in Italy, which will be conducted at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome.

"This achievement marks a fundamental step in our commitment to innovation in oncology and demonstrates the trust of Italian institutions in our technology and the therapeutic potential of YntraDose for patients with unresectable locally advanced pancreatic cancer" said Alexis Peyroles, CEO of BetaGlue Therapeutics. "We are grateful for the support of the Italian institutions and look forward to collaborating with the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome bringing new hope to patients with unresectable locally advanced pancreatic cancer, one of the most challenging diseases worldwide. Looking ahead, we are actively planning to expand our clinical trials internationally, with the goal of making YntraDose available to patients in more countries and addressing unmet needs in cancer care worldwide."

Propanc Biopharma Requests Foreign Filing License from Spain for Methods of Treating Resistant Cancer and Fibrosis

On December 1, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel treatments for recurrent and metastatic cancer, reported that it has submitted a request for a foreign filing license from Spain for two provisional patents detailing new methods to treat resistant cancer and fibrosis. The patents will be filed with IP Australia under Propanc Pty Ltd, the Company’s wholly owned operating subsidiary based in Melbourne, Australia. These discoveries stem from Propanc’s Joint Research and Drug Discovery program with the Universities of Jaén and Granada in Spain and are expected to be filed subsequently in key global jurisdictions.

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The first provisional patent covers methods for treating cancers that have developed resistance to chemotherapy and/or radiotherapy. Despite advancements in cancer therapies, global mortality rates remain high, and strategies to prevent recurrence are urgently needed. Treatment failure frequently occurs due to the emergence of multiple malignancies and resistance to standard therapies, underscoring the need for novel approaches.

The second provisional patent relates to compositions, methods, uses, and kits for the treatment of fibrosis, particularly organ fibrosis. Fibrosis is characterized by the excessive accumulation of scar tissue due to over-deposition of extracellular matrix (ECM) components, leading to stiffening, loss of function, and structural disruption of affected tissues. This maladaptive response can result from chronic injury or persistent inflammation and can impact nearly any organ system, including the lungs, liver, kidneys, and heart—contributing significantly to morbidity and mortality. Causes may include chronic inflammation, autoimmune and allergic responses, chemical insults, radiation, and tissue damage. For example, life expectancy following myocardial infarction-related scarring ranges from 3 to 8 years (ages 65–74), and for lung fibrosis patients is typically 3 to 5 years.

This fibrosis-related patent represents a world-first in Propanc’s intellectual property portfolio by describing the use of the Company’s lead product candidate, PRP—its proenzyme therapy—for chronic diseases beyond cancer. The biological pathways modulated by PRP to alter cancer cell behavior may also be applicable to conditions such as fibrosis. In particular, the epithelial-to-mesenchymal transition (EMT), a biological process central to embryogenesis and wound healing, plays a critical role in both tumor progression and tissue repair, making it a promising therapeutic target.

"The submission of these two patents represents a significant turning point for Propanc and the commercial potential of PRP for treating chronic diseases such as cancer and fibrosis," said James Nathanielsz, Propanc’s Chief Executive Officer. "Our planned Phase 1b, First-In-Human study in 2026 will define the target therapeutic dose of PRP, enabling us to explore this unique proenzyme therapy across multiple disease conditions in Phase 2 proof-of-concept studies. This work will be instrumental in establishing PRP as a novel therapeutic approach that encourages cells to differentiate toward normal behavior—without the cytotoxic effects associated with many standard treatments. We are tremendously excited by these developments."

(Press release, Propanc, DEC 1, 2025, View Source [SID1234661022])

Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients on Wednesday, December 3, 2025

On December 1, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC). The data will be featured during a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO). The Company will also provide an update on feedback from the U.S. Food and Drug Administration on a registrational path forward for TARA-002 in BCG-Naïve patients.

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The live event and accompanying slides can be accessed by visiting View Source or via the Events and Presentations section of the Company’s website: View Source A replay of the webcast will be archived for a limited time following the event.

(Press release, Protara Therapeutics, DEC 1, 2025, https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-host-conference-call-and-webcast-review-1 [SID1234661023])

Syndax Announces Participation at the 8th Annual Evercore Healthcare Conference

On December 1, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Thursday, December 4, 2025, at 11:15 a.m. ET.

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A live webcast of the fireside chat will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

(Press release, Syndax, DEC 1, 2025, View Source [SID1234661024])

Plus Therapeutics to Present ReSPECT Phase 1 Dose Escalation Study Results for Leptomeningeal Metastases at the 2025 San Antonio Breast Cancer Symposium

On December 1, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX.

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Poster Spotlight Presentation:

Title Rhenium (186Re) obisbemeda (rhenium nanoliposome, 186RNL) for the treatment of leptomeningeal metastases (LM): Phase 1 dose escalation study results

Presenter Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio

Presentation
Date/Time Friday, December 12, 2025, 7:39am to 7:42 am CST

Session
Date/Time Friday, December 12, 2025, 7:00am to 8:30 am CST

Location
Hemisfair 3, Henry B. Gonzalez Convention Center

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, DEC 1, 2025, View Source [SID1234661025])