On December 17, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of a new study in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The paper, titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," details results from Dr. Rodrigo Toledo and a leading team at the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain. The study provides compelling clinical evidence that the company’s ultra-sensitive, tumor-informed molecular residual disease (MRD) assay, NeXT Personal, can effectively predict patient outcomes across a diverse set of cancers and immunotherapy modalities.

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The study analyzed 202 patients with stage IV solid tumors—spanning 24 different cancer types—treated with immune checkpoint inhibitors and other immunotherapies. Utilizing a personalized testing approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor, the NeXT Personal test achieves ultrasensitive detection of small traces of circulating tumor DNA (ctDNA) from a patient’s blood sample.

Key findings published in Clinical Cancer Research include:

High Sensitivity: The test detected ctDNA in 98% of patients at baseline across all 24 tumor types, demonstrating robust performance even in a diverse set of cancers.
Early ctDNA Dynamics are Highly Prognostic: Patients who demonstrated decreases in ctDNA levels early in immunotherapy treatment had significantly higher overall survival. Conversely, patients with increasing ctDNA levels early while on immunotherapy had a zero percent overall response rate.
Durable ctDNA Clearance was a Positive Predictor: Patients who achieved durable molecular clearance (negative ctDNA for at least 180 days) had 100% overall survival (OS) in the study.
"We are excited about these results showing how NeXT Personal can be used to monitor therapy in late-stage metastatic patients," said Rich Chen, M.D., M.S., Chief Medical Officer and Executive Vice President, R&D at Personalis. "This study, together with our previous publications, shows the broad potential impact of ultrasensitive ctDNA testing, both in early and late stage cancers."

Dr. Rodrigo Toledo, Group Leader of the Biomarkers and Clonal Dynamics Laboratory at VHIO and senior author of the study, noted, "immunotherapy has revolutionized cancer care, but response patterns can be difficult to interpret using imaging alone. Our findings show that ultrasensitive ctDNA dynamics provide a clear, early molecular view of benefit or non-response, offering a powerful tool to guide patient management across a broad spectrum of solid tumors."

(Press release, Personalis, DEC 17, 2025, View Source [SID1234661515])

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 17, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported the nomination of CID-165, a first-in-class, orally bioavailable macrocyclic cyclin D1 RxL inhibitor, as the development candidate for its second oncology program.

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Cyclin D1 is a regulatory protein that plays a crucial role in cell cycle progression and is overexpressed or translocated in malignancies, including ER-positive breast cancer and lymphomas. In these cancers, cyclin D1 drives cell proliferation by binding to the tumor suppressor retinoblastoma protein (Rb) leading to uncontrolled cell division. In preclinical studies, CID-165 has been shown to potently and selectively disrupt the cyclin D1-Rb interaction allowing Rb to remain active and suppress cancer cell proliferation. CID-165 demonstrates robust anti-tumor activity in cyclin D1-driven preclinical cancer models including in combination with other therapies such as CDK4/6-dual inhibitors, CDK4-selective inhibitors, and endocrine therapies.

"Cyclin D1 has long been recognized as a key oncogenic driver across many solid tumors and hematologic malignancies, yet it has remained an elusive direct therapeutic target," said Marie Evangelista, Ph.D., senior vice president and head of cancer biology at Circle Pharma. "Our MXMO platform has allowed us to design a novel macrocyclic molecule, CID-165, with the precision and selectivity needed to directly block cyclin D1-Rb signaling while minimizing effects on related cyclins, such as cyclin D3, an approach aimed at reducing side effects commonly observed with dual CDK4/6 inhibitors."

"Despite the transformative impact of CDK4/6 inhibitors for the treatment of ER-positive breast cancer, many patients eventually experience disease progression or adverse events that impact their quality of life," said Anne Borgman, M.D., chief medical officer of Circle Pharma. "CID-165 is designed to address these limitations through selective inhibition of cyclin D1, a central driver of tumor proliferation, while avoiding adverse events associated with broader CDK4/6 blockade. We look forward to advancing CID-165 toward IND submission in late 2026 and potentially translating the compelling preclinical activity into benefit for patients."

(Press release, Circle Pharma, DEC 17, 2025, View Source [SID1234661500])