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Black Diamond Therapeutics to Host Webcast Presentation Highlighting Silevertinib Phase 2 Clinical Trial Results and Program Update

On December 2, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported it will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.

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Webcast information

The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event.

(Press release, Black Diamond Therapeutics, DEC 2, 2025, View Source [SID1234661042])

Aurigene Oncology Limited Announces Encouraging Initial Data From 1st Two Cohorts of Phase 1 Study of AUR112, an Oral Small Molecule inhibitor of MALT1, in Relapsed/Refractory Lymphoid Malignancies

On December 2, 2025 Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, reported initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity, with objective responses observed across multiple lymphoma subtypes, including Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).

"We are very encouraged by the early results of the first two cohorts from our Phase 1 study of AUR112," said Dr. Murali Ramachandra, CEO. "AUR112 has shown a promising initial clinical profile, achieving an overall response rate of 63.6% in the efficacy-evaluable population and 58.3% in the intent-to-treat group. These strong early data, combined with its distinct preclinical and safety characteristics, reinforce our belief that AUR112 has the potential to become a best-in-class MALT1 inhibitor."

Study Design and Key Findings

The company is currently conducting a Phase 1 dose-escalation study evaluating AUR112 monotherapy in patients with relapsed/refractory lymphoid malignancies. Primary objectives include characterizing safety and identifying dose-limiting toxicities and secondary objectives include pharmacokinetics, pharmacodynamics, objective response rate, duration of response, and disease control rate.

As of the November 21, 2025 cutoff, 13 patients were evaluable for safety and 11 patients were evaluable for efficacy across three dose cohorts (100 mg, 200 mg, and 400 mg).

Safety: AUR112 was generally well tolerated. While 84.6% of patients experienced Treatment Emergent Adverse Events (TEAEs), only 14 events in 7 patients were treatment-related. No Grade 3 or higher hyperbilirubinemia was observed, and bilirubin elevations resolved even with continued treatment. One dose-limiting toxicity (DLT) (Grade 3 neutropenia) and two DLT-equivalent events were reported.
Pharmacokinetics/Pharmacodynamics: Drug exposure at 200 mg appears to be in the efficacious range, however further results are awaited. Pharmacodynamic data demonstrated rapid and sustained IL-2 inhibition, with all evaluated patients showing IL-2 levels below the limit of quantification by Cycle 1 Day 15.
Efficacy: Among 11 efficacy-evaluable patients (all in 1st two cohorts), the overall response rate was 63.6%, including six partial responses and one complete response. Responses were observed in MCL, MZL, Hodgkin Lymphoma (HL), and Diffuse Large B-Cell Lymphoma (DLBCL).
Based on these encouraging results, the initiation of dose-expansion cohorts in select lymphoid malignancies, including Chronic Lymphocytic Leukemia (CLL), Waldenström’s Macroglobulinemia, MCL, and MZL are being planned.

About AUR112

AUR112 is an oral investigational MALT1 inhibitor designed to target a pivotal signaling node in the NF-κB pathway. Through highly potent and selective inhibition of MALT1, AUR112 aims to disrupt survival mechanisms that drive B-cell malignancies. In preclinical studies, AUR112 exhibited significant monotherapy activity and demonstrated a favorable safety profile.

(Press release, Aurigene Discovery Technologies, DEC 2, 2025, View Source [SID1234661041])

Alpha Tau Receives FDA Approval to Initiate a Trial for Patients with Locally
Recurrent Prostate Cancer

On December 2, 2025 Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology.

"We are excited to bring the Alpha DaRT technology to prostate cancer patients in the U.S.," said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. "According to the National Cancer Institute, over 300,000 new cases of prostate cancer will be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. We look forward to exploring Alpha DaRT as a new local salvage therapy for patients with recurrent prostate cancer, as an alternative to systemic androgen deprivation therapy."

The clinical trial is expected to enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). The primary objective of the study is to evaluate the safety of the treatment, following the Company’s promising results from clinical study treatments in Israel, and the secondary objective of the study is to evaluate the efficacy of Alpha DaRT as assessed by biochemical and clinical evaluation of disease progression as well as overall survival.

"With this IDE approval, our fifth in the U.S. currently active, Alpha Tau continues to broaden its reach in the U.S. across a range of tumor types. We have repeatedly heard the demand from clinicians and patients who want a new, focused alpha-radiation based local salvage therapy for prostate cancer, and are eager to explore the benefits that Alpha DaRT may bring to recurrent prostate cancer patients, who currently face a number of poor available alternatives," added Alpha Tau Chief Executive Officer Uzi Sofer.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, DEC 2, 2025, View Source [SID1234661040])

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).

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."

One-carbon Therapeutics announces oversubscribed private placement financing of SEK 153 million (€13.9 million)

On December 1, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering first-in-class cancer therapies, reported the closing of an oversubscribed 153 million SEK (€13.9 million) private placement financing round supported by current and new investors and private Swedish family offices.

One-carbon Therapeutics will use the net proceeds from the private placement to strengthen its financial position and expand its ongoing Phase 1/2 ODIN clinical study of TH9619, an MTHFD1/2 inhibitor, thereby further accelerating its momentum through a data-driven strategy. The financing follows the company’s recent important milestone of dosing the first subject in the ODIN Phase 1/2 study – marking One-carbon Therapeutics’ successful transition from preclinical to clinical-stage company.

"We are very encouraged by the strong confidence and enthusiasm shown by our existing and new investors, who recognize the potential of our lead asset. Their support is crucial for securing rapid execution and delivery of the potential new therapy to patients in need," said Ana Slipicevic, Chief Executive Officer.

One-carbon Therapeutics also extends its appreciation to clinical and academic collaborators, partners and advisors for their continued trust and partnership, and for their belief in our vision and science. Their support has been instrumental in driving the company’s scientific and clinical progress, enabling the advancement of TH9619.

Selma Legal AB has served as legal adviser to One-carbon Therapeutics AB in the transaction.

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway. TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first-in-human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, DEC 1, 2025, View Source [SID1234661125])