On December 2, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid sparing inhibitor of prostaglandin mediated inflammation, reported that preliminary safety data from its Phase 1b/2a clinical trial for its lead drug candidate, CTO1681, will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.

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CTO1681 is an oral, small molecule immune modulator that uses a novel approach to prevent and mitigate both inflammation in the tumor microenvironment as well as toxicity frequently seen with lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ASH (Free ASH Whitepaper), the company will present preliminary safety data from the first patient cohort of the Phase 1b/2a clinical trial. Among the key findings to be presented, CTO1681 was shown to be well tolerated at the 10μg three times a day (TID) dose. Importantly, no dose-limiting toxicities and no drug-related serious adverse events were observed in the cohort. Based on these positive findings, CytoAgents is currently enrolling the second cohort of the trial, an escalated dosage of 20μg TID.

"New approaches to treat inflammation in the tumor microenvironment as well as black box warning toxicities, Cytokine Release Syndrome (CRS) and the neurotoxicity ICANS, continues to be an area of significant unmet medical need, with the majority of cancer patients undergoing CAR T treatment experiencing CRS and associated neurotoxicity," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing this initial positive safety data for CTO1681 at ASH (Free ASH Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details

Title: A phase 1b/2a study of CTO1681 for the prevention of cytokine release syndrome in patients with diffuse large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy
Presenter: Jordan Gauthier, MD, MSc, Associate Professor, Clinical Research Division, Fred Hutchinson Cancer Center, Clinical Research Division, Seattle, WA, USA
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Publication Number: 5955
Session Date and Time: Sunday, December 7, 2025, 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center – West Halls B3-B4

CytoAgents also announced that research from its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of CTO1681 in healthy adult participants has been selected by ASH (Free ASH Whitepaper) for online publication. The abstract, entitled "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of CTO1681 (GP1681) in Healthy Adult Participants", will be published online in the November supplemental issue of Blood and will become part of the permanent ASH (Free ASH Whitepaper) and Blood abstracts archive.

(Press release, CytoAgents, DEC 2, 2025, View Source [SID1234661044])

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])

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).

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"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])

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.

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"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])

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."