Accuray to Participate at 37th Annual Roth Conference

On March 12, 2025 Accuray Incorporated (NASDAQ: ARAY) reported its participation in the 37th Annual Roth Conference taking place on March 16 -18, 2025 in Dana Point, California (Press release, Accuray, MAR 12, 2025, View Source [SID1234651102]).

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Management will participate in a fireside chat on Tuesday, March 18, 2025, at 9:30am PT / 12:30pm ET, and will be available for one-on-one meetings with investors.

A live webcast of the fireside chat can be accessed here and on the Accuray website at investors.accuray.com. The webcast replay of the presentation will be available on the company’s website about one hour after the conclusion of the live presentation and will be available for 90 days.

Triumvira Immunologics to Present Updated Clinical Data at the 2025 SITC Spring Scientific, Cellular Therapy and Solid Tumors Conference

On March 12, 2025 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported it will present at the 2025 SITC (Free SITC Whitepaper) Spring Scientific, Cellular Therapy and Solid Tumors Conference in San Diego, California, from March 12-14, 2025 (Press release, Triumvira Immunologics, MAR 12, 2025, View Source [SID1234651101]). The poster presentation, titled "A Phase 1/2 Study on the Safety and Efficacy of Autologous TAC T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors," will provide a detailed overview of interim findings from the Phase 1/2 study (TACTIC-3 /NCT05862324).

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The TAC technology platform, demonstrated by TAC01-CLDN18.2, reprograms T cells to harness the natural T cell receptor (TCR) signaling complex, enabling precise tumor targeting while minimizing systemic toxicity compared to conventional engineered T cell therapies.

"We are excited to share the latest clinical data from our ongoing TACTIC-3 study at the 2025 SITC (Free SITC Whitepaper) Spring Scientific Conference. These interim findings further reinforce the potential of our TAC technology to deliver safe and effective cell therapies for patients with Claudin 18.2+ advanced solid tumors," said Robert Williamson, President of Triumvira Immunologics. "At Triumvira, we remain committed to pioneering innovative T cell therapies that harness the natural biology of T cells, offering new hope to patients with limited treatment options."

Details of the abstract presentation are as follows:

Abstract Number: 28
Abstract Title: A phase 1/2 study evaluating the safety and efficacy of autologous TAC T cells in subjects with claudin 18.2+ advanced solid tumors
Authors: Ecaterina E. Dumbrava, Syma Iqbal, Simon Turcotte, Gregory Botta, Benjamin Schlechter, Geoffrey Ku, Peter Hosein, Sam Saibil, Miriam Gavriliuc, Maria Apostolopoulou, Mobolaji Giwa, Kara Moss, Swaminathan Murugappan, Davendra Sohal
Date: Thursday, March 13, 2025, at 4:05 pm PDT
About TACTIC-3

The TACTIC-3 trial (NCT05862324) is a first-in-human Phase 1/2 study designed to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetics, and efficacy of TAC101-CLDN18.2 in patients with Claudin 18.2+ solid tumors who have undergone 2 or more lines of prior therapy (1 prior line in patients with pancreatic tumors). The trial includes subjects with advanced gastric and other solid tumors expressing Claudin 18.2, with the potential to address significant unmet medical needs in oncology.

GC Cell Initiates First Patient Dosing in Phase 1 Clinical Trial for GCC2005, a Promising T‑Cell Lymphoma CD5 CAR-NK Therapy

On March 12, 2025 GC Cell (KRX:144510), under the leadership of CEO Sungyong Won, reported the initiation of its domestic Phase 1 clinical trial for GCC2005 (AB‑205), a novel CD5 CAR‑NK cell therapy (Press release, GC Cell, MAR 12, 2025, View Source [SID1234651100]). This "first patient dosing" marks a critical milestone in the company’s collaboration with its ex-APAC partner Artiva Biotherapeutics, as we advance the development of this innovative treatment targeting relapsed or refractory NK and T‑cell malignancies.

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With GCC2005, GC Cell is striving to fulfill a significant unmet need in oncology. T‑cell lymphomas, which often arise in extranodal lymphoid tissues, are highly aggressive and generally exhibit a poorer prognosis than their B‑cell counterparts with limited treatment options.

Aimed at expanding possibilities for NK‑cell therapies, GCC2005 is an allogeneic cell therapy product manufactured using umbilical cord blood–derived NK cells. Engineered to target the CD5 marker—which is highly expressed on T‑cell lymphomas—GCC2005 co‑expresses a chimeric antigen receptor (CAR) alongside interleukin‑15 (IL‑15). This dual expression is designed to enhance the persistence and anti‑tumor efficacy of NK cells—effectively addressing a common limitation of conventional NK-cell therapies.

The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT06699771) will enroll up to approximately 48 patients diagnosed with relapsed or refractory NK and T‑cell malignancies. The primary objectives of the study are to evaluate the safety and tolerability of GCC2005, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D).

"The initiation of this Phase 1 trial marks a significant step toward expanding treatment options for patients with T-cell lymphomas," said Dr. Won Seog Kim of Samsung Medical Center, the lead investigator of the study. "With this first patient dosing, we anticipate contributing to both the advancement of CAR-NK therapies and the expansion of this emerging treatment landscape."

Preclinical efficacy data presented last year at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the T Cell Lymphoma Forum (TCLF) highlighted GCC2005’s potent ability to kill tumor cells and improve in vivo persistence. These promising results have bolstered expectations that GCC2005 could become a global first‑in‑class therapeutic option for T‑cell lymphoma. In recognition of its innovative potential, GCC2005 has also been selected by a Korea Drug Development Fund program aimed at promoting global market entry and strategic partnerships in drug development.

"Building on our robust preclinical results, we are excited to commence the Phase 1 clinical trial of GCC2005. This study represents an important step toward providing a new treatment option for patients with relapsed or refractory NK and T‑cell malignancies," said a GC Cell representative. "Our collaboration with Artiva Biotherapeutics and the recognition received through national support programs further validate our commitment to advancing breakthrough therapies in this challenging area."

Next-Gen Cancer Treatment: Rakovina’s AI-Driven ATR Inhibitors Enter Preclinical Testing

On March 12, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV)(FSE: 7JO), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported that the company has received the first synthesized batch of AI-generated ATR inhibitor compounds developed in collaboration with Variational AI (Press release, Rakovina Therapeutics, MAR 12, 2025, View Source;utm_medium=rss&utm_campaign=next-gen-cancer-treatment-rakovinas-ai-driven-atr-inhibitors-enter-preclinical-testing [SID1234651098]).

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This milestone marks a significant step forward in Rakovina’s mission to accelerate drug discovery using advanced AI-driven platforms. In September 2024, Rakovina announced its partnership with Variational AI to leverage the Enki generative AI platform for the development of next-generation DNA Damage Response (DDR) inhibitors. Following a rigorous AI-driven selection process, the company shortlisted the most promising ATR inhibitor candidates for synthesis. The first batch of these compounds will now move into preclinical testing at Rakovina’s state-of-the-art, integrated wet lab for further evaluation and validation. Results from this phase will guide the selection of lead candidates for further optimization and potential clinical development.

"We are excited to advance our first AI-designed ATR inhibitors into preclinical testing," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "This represents a major step in leveraging generative AI for drug discovery. The speed and precision of AI in identifying novel, high-potential compounds will significantly accelerate the development of next-generation cancer therapies."

Advancing the Fight Against ATR-Targeted Cancers

ATR (Ataxia Telangiectasia and Rad3-related) inhibitors play a critical role in targeting cancers with DNA repair deficiencies, such as ovarian, breast, and prostate cancers. Despite the potential of ATR inhibitors, no FDA-approved treatments currently exist in this category. Rakovina’s AI-driven approach aims to address this gap by rapidly identifying and optimizing ATR-targeted compounds with strong therapeutic potential — including candidates designed to effectively cross the blood-brain barrier, offering new hope for patients with cancers that affect the central nervous system.

Portage Biotech Resumes Enrollment in Final Cohort of Dose Escalation for Port-6 in ADPORT-601 Trial

On March 12, 2025 Portage Biotech Inc. ("Portage" or the "Company") (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of innovative therapeutics, reported the resumption of patient enrollment in the fourth and final cohort of the dose escalation stage for PORT-6, a highly selective A2A antagonist, within its ADPORT-601 Phase 1b clinical trial (Press release, Portage Biotech, MAR 12, 2025, View Source [SID1234651097]). Portage had previously paused this trial due to funding concerns; this resumption of the trial underscores the encouraging findings observed in earlier cohorts. After the completion of the PORT-6 arm of the ADPORT-601 study, Portage will evaluate the continuation of the study into its PORT-7 (potent and selective A2B antagonist) and combination arms, on a segment-by-segment basis.

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Advancing to this final dose escalation reaffirms Portage’s confidence in the safety and therapeutic potential of PORT-6, bringing the Company closer to identifying an optimal dose range for further clinical development.

"Our review of the preliminary data reinforces our confidence in PORT-6 and supports the decision to complete dose escalation," said Alexander Pickett, Chief Executive Officer of Portage Biotech. "We remain encouraged by the trial’s progress and potential and look forward to sharing further clinical updates later this year."

Combining PORT-6 and PORT-7 for a More Comprehensive Immunotherapy Approach

In parallel, Portage is making final preparations for PORT-7, a potent and selective A2B antagonist, before dose escalation can commence in the same trial. The planned co-administration of PORT-6 and PORT-7 in ADPORT-601 will mark the first time two highly selective A2A and A2B antagonists are combined in patients, aiming to achieve a complete blockade of adenosine-induced immunosuppression in the tumor microenvironment. This innovative approach is designed to fully neutralize adenosine-mediated immune suppression, enhance anti-tumor responses, and broaden the impact of immunotherapy in solid tumors.