On March 12, 2025 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT) reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Assertio Holdings, MAR 12, 2025, View Source [SID1234654208]).

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Said Brendan O’Grady, Chief Executive Officer, "In line with our strategy for Assertio’s long-term growth, 2024 was a year of stabilization as we transitioned to Rolvedon as our primary asset. We enhanced our leadership team and board with additional expertise in legal, commercial, and strategy areas, optimized our cost structure, and strengthened our balance sheet with over $26 million in cash flow generated by the performance of our assets.

"We expect 2025 will be a transformational year focused on initiatives designed to drive revenue growth in Rolvedon and Sympazan by investing to unlock new opportunities, continuing to manage our legal exposure and associated costs, while simplifying our structure.

"We are also actively pursuing our acquisition strategy, seeking to deploy our balance sheet into appropriate commercial assets that fit our model, enhance our scale and better position ourselves for near-term growth. We remain diligent in these efforts with regard to finding the proper fit and pricing of assets that can deliver results within our targeted metrics as we work to build on the commercial platform at Assertio."

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.

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."

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.

On March 12, 2025 Pierre Fabre Laboratories and RedRidge Bio ("RedRidge") reported an exclusive R&D collaboration and license agreement to identify and develop biparatopic antibody (BPA) drug candidates against multiple targets (Press release, Pierre Fabre, MAR 12, 2025, View Source [SID1234651082]). In line with Pierre Fabre Laboratories’ innovation strategy, the partnership’s therapeutic focus will be on precision oncology as well as dermatology and rare diseases.

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Under the terms of the agreement, RedRidge will provide its capabilities to engineer, screen and characterize BPAs against an undisclosed portfolio of jointly nominated targets, while Pierre Fabre Laboratories will provide their drug development expertise to help drive two co-development programs through clinical development. RedRidge will hold exclusive commercial rights in the United States, Canada, and Japan for both programs, while Pierre Fabre Laboratories will hold exclusive rest-of-world rights. In addition, Pierre Fabre Laboratories will hold exclusive worldwide rights for a third program after a hand-off by RedRidge at a preclinical stage.

Financial terms of the agreement are not disclosed but include investment participation by Pierre Fabre Laboratories in RedRidge’s Series A financing that will be announced separately, as well as upfront, milestone and future sales royalty payments in addition to funded research payments for Pierre Fabre Laboratories’ worldwide program. RedRidge and Pierre Fabre Laboratories will share R&D costs for the co-development programs.

"This strategic alliance attests to the RedRidge team’s expertise in innovation and drug discovery for a wide variety of therapeutic targets. We are thrilled to join forces with Pierre Fabre Laboratories as a highly experienced development partner and look forward to building a long-term partnership that synergistically leverages the capabilities of each company," said Alex Mayweg, PhD, chairperson of RedRidge’s board and a managing director at Versant Ventures.

"Pierre Fabre Laboratories are excited to enter into this agreement with RedRidge, which confirms our commitment to collaborate with innovative biotechnology companies. This partnership will allow us to capitalize on RedRidge’s cutting-edge expertise in biparatopic antibody drug discovery to deliver high quality clinical candidates on multiple targets addressing oncology, dermatology and rare diseases. It represents a significant milestone in the implementation of our strategy to enrich further our R&D pipeline," stated Francesco Hofmann, PhD, Head of Research and Development for Medical Care at Pierre Fabre Laboratories."