On December 17, 2025 Talus Bioscience, Inc. ("Talus Bio"), an AI-enabled regulome therapeutics company, reported a strategic collaboration with PRISM BioLab Co., Ltd. ("PRISM") to accelerate the discovery and development of novel small-molecule modulators of transcription factor (TF) and protein-protein interaction (PPI) targets. The collaboration combines Talus Bio’s pioneering regulome profiling and AI-guided drug discovery platform with PRISM’s innovative chemistry.

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"This collaboration gives us an unprecedented opportunity to pursue targets that have resisted conventional drug discovery," said Alex Federation, PhD, CEO and Co-Founder of Talus Bio. "Integrating PRISM’s chemistry with Talus’ regulome profiling and AI models allows us to see, in real time, how compounds reshape transcriptional networks in human cells. It’s a step-change in our ability to drug the undruggable."

Under the agreement, the companies will deploy PRISM’s proprietary small-molecule libraries in Talus Bio’s AI-guided regulome profiling screens to identify and optimize novel compounds against high-value TF and PPI targets. The collaboration aims to generate first-in-class chemical matter with direct functional effects on TF and PPI activity in live human cells. Talus Bio and PRISM will share the costs of discovery research and development and any profits generated from out-licensing and commercialization of discovered drug products.

"We are delighted to partner with Talus on this exciting project," commented Dai Takehara, PRISM’s President and CEO. "We at PRISM have developed chemistries for PPI targets, but because of the complex nature of these targets, it is often challenging to properly model protein-protein interactions in a biochemical assay. Even when we are successful, we can interrogate only one target at a time, whereas Talus can profile hundreds to thousands of these targets in parallel and in their native environment. We believe that the combination of PRISM’s chemistry platform and Talus’s regulome profiling platform has the potential to discover a plethora of inhibitors against previously ‘undruggable’ TF and PPI targets and open a path for the development of novel therapeutics."

This collaboration is a pivotal step in establishing a systematic, scalable strategy to address TF and PPI targets. Together, the companies are creating a unified platform capable of revealing and modulating regulatory mechanisms that have remained undruggable for decades. The approach opens the door to long-needed therapies for transcriptionally driven diseases that lie beyond the capabilities of traditional small-molecule approaches.

Talus Bio will be attending the 2026 J.P. Morgan Healthcare Conference in San Francisco, January 12–15. For information on partnership and co-development opportunities, contact the Talus Bio team here. Follow Talus Bioscience on LinkedIn for the latest news and updates.

(Press release, Talus Bioscience, DEC 17, 2025, View Source [SID1234661516])

On December 17, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy Conjugate ("ATTC") comprising a highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker. Study sites are in the US and China. The first patient received the first dose on December 16, 2025, in China.

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This first-in-human Phase I/IIa, open-label, multicenter clinical study evaluates HMPL-A251 monotherapy in adult patients with unresectable, advanced or metastatic HER2-expressing solid tumors. The study is divided into two parts, a Phase I dose escalation part and a Phase IIa dose expansion and optimization part. The primary outcome measures are to evaluate the safety and tolerability of HMPL-A251 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion ("RDE") in the Phase I part, and to further evaluate safety and preliminary efficacy at RDEs and to determine the recommended dose for Phase II (RP2D) or Phase III (RP3D) in the Phase IIa part. Secondary outcome measures include preliminary antitumor activity, pharmacokinetic profile, and the immunogenicity of HMPL-A251. Additional details may be found at clinicaltrials.gov, using identifier NCT07228247.

HMPL-A251 is the first clinical-stage candidate derived from HUTCHMED’s next-generation ATTC platform. The first family of programs are based on a highly potent and selective PI3K/PIKK inhibitor payload. By conjugating this highly novel payload to an anti-HER2 antibody, the molecule is designed to deliver targeted pathway inhibition directly into HER2-expressing tumor cells, thereby potentially overcoming the systemic toxicity and narrow therapeutic index historically associated with PI3K/PIKK inhibitors. This approach aims to achieve deeper and more durable target inhibition while improving the overall tolerability profile.

Preclinical data for HMPL-A251 were presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). This body of evidence supports the translational potential of the ATTC platform, the ongoing global clinical evaluation of HMPL-A251, and the broad potential of HUTCHMED’s PI3K/PIKK inhibitor linker-payload to underpin a family of future ATTC drug candidates.

About the ATTC Platform
HUTCHMED’s ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

About the PAM Pathway and HMPL-A251
The PI3K/AKT/mTOR ("PAM") pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant challenges, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. HUTCHMED has designed a highly novel PI3K/PIKK inhibitor linker-payload to overcome these challenges with broad potential to lead to a family of antibody conjugate drug candidates.

HMPL-A251 is a first-in-class ATTC comprising of this highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker, designed to address challenges by enhancing targeted delivery directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure. In preclinical studies, the HMPL-A251 payload exhibited high selectivity, potency, and robust anti-tumor activity. HMPL-A251 exhibited superior anti-tumor efficacy and tolerability compared to co-administration of the naked antibody and payload.

(Press release, Hutchison China MediTech, DEC 17, 2025, View Source [SID1234661460])

On December 17, 2025 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported that Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 from 5:15 PM to 5:55 PM Pacific Time. Additionally, Biomea’s management team will host one-on-one meetings throughout the conference, which will take place from January 12-15.

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A live audio webcast of the presentation can be accessed here or by visiting the Investors & Media section of Biomea’s website at View Source A replay of the webcast will be available following the live presentation.

(Press release, Biomea Fusion, DEC 17, 2025, View Source [SID1234661499])

On December 16, 2025 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, reported that dosing of the first cohort has been completed in the ATLAS trial, a Phase 1/2 open-label study evaluating the safety, tolerability, and efficacy of the company’s lead therapeutic radiopharmaceutical, [Ac-225]-RTX-2358, targeting fibroblast activation protein‑α (FAP) in patients with relapsed or refractory soft tissue sarcomas.

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"Advancing [Ac-225]-RTX-2358 into the clinic represents a major milestone for our company and reflects years of dedicated and innovative work by our team," said John Babich, Ph.D., President and Chief Scientific Officer of Ratio. "The preclinical and early human experience point to a strong therapeutic profile for our drug in sarcoma, with encouraging signs of activity in additional FAP-expressing cancers. Initiation of this trial marks the entry of our first therapeutic into the clinic and underscores our commitment to developing innovative radiotherapies that can bring new treatment options to cancer patients."

"This study represents an important step in exploring a novel therapeutic approach for patients with relapsed or refractory sarcoma, a population with limited treatment options," said Dr. Sandra D’Angelo, MD, a Medical Oncologist specializing in the care of patients with sarcoma at Memorial Sloan Kettering Cancer Center. "Radiopharmaceuticals are transforming cancer treatment by delivering radiation directly to tumors with far greater precision and decreased side effects. Ratio’s technology is designed to further enhance these benefits, and we look forward to exploring the potential of [Ac-225]-RTX-2358 to provide a meaningful impact for patients suffering from this challenging disease."

About the ATLAS Trial

The ATLAS trial is a Phase 1/2 open-label clinical trial (clinicaltrials.gov identifier, NCT07156565) designed to assess the safety, tolerability, dosimetry, biodistribution, pharmacokinetics, and preliminary anti-tumor activity of [Ac-225]-RTX-2358, a highly selective, FAP targeted radiotherapeutic labeled with Actinium 225, in patients with relapsed or refractory soft tissue sarcomas that express FAP.

The study consists of two phases: an ascending administered activity phase (Phase 1) and an expansion phase (Phase 2). For patients to be eligible to receive treatment, FAP expression will be assessed using a [Cu-64]-LNTH-1363S PET scan. In the Phase 1 portion, patients with FAP positive sarcomas will receive intravenous injections of [Ac-225]-RTX-2358 once every eight weeks, for up to six treatment cycles over a 12-month period. Using a standard 3+3 dose escalation design, participants will be assigned to one of three groups, each receiving an increasing dose level to determine the maximum tolerated dose and establish a recommended dose for the expansion phase. Cohort expansion will be allowed to a max of 10 patients per cohort, enabling up to 26 patients to be treated and evaluated during the Phase 1 portion of the trial. This will allow better characterization of safety and tolerability as well as the assessment of preliminary efficacy. Safety data from each group will be reviewed by an independent Safety Review Committee before dose escalation proceeds. The Phase 2 portion of the study will evaluate the efficacy and safety of [Ac-225]-RTX-2358 in up to 50 patients. [Ac-225]-RTX-2358 is being manufactured by Pharmalogic. [Cu-64]-LNTH-1363S is being provided by Lantheus and manufactured by PharmaLogic.

Dr. D’Angelo provides consulting and advisory services to Ratio Therapeutics.

(Press release, Ratio Therapeutics, DEC 16, 2025, https://ratiotx.com/2025/12/16/ratio-therapeutics-has-successfully-dosed-the-first-cohort-in-its-phase-1-2-study-evaluating-a-novel-fap-targeted-radiopharmaceutical-in-patients-with-late-stage-aggressive-sarcomas/ [SID1234661461])

On December 16, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported a multi-year, global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multi-specific antibodies.

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Under the terms of the agreement, Harbour BioMed will collaborate with Bristol Myers Squibb to advance and accelerate multi-specific antibody discovery programs. In return, Harbour BioMed could receive payments totaling $90 million, as well as development and commercial milestones of up to $1.035 billion, along with tiered royalties should Bristol Myers Squibb elect to advance all potential programs.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "We are delighted to collaborate with Bristol Myers Squibb to advance next-generation multi-specific antibody discovery and development. This collaboration leverages our Harbour Mice fully human antibody technology platform, which facilitates the efficient discovery and development of innovative biologics with enhanced therapeutic potential. Furthermore, the collaboration offers the possibility to utilize our established development capabilities to accelerate programs by conducting early clinical trials in China. By uniting the strengths of our platform with Bristol Myers Squibb’s expertise in drug discovery and development, we look forward to progressing these programs and delivering transformative therapies to patients worldwide."

(Press release, Harbour BioMed, DEC 16, 2025, View Source [SID1234661463])