Aclaris Therapeutics to Participate in Three November Healthcare Conferences

On October 29, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported that the Company will participate in three upcoming healthcare conferences in November.

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On Wednesday November 12, 2025, at 11:00 AM EST, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Guggenheim 2nd Annual Healthcare Conference in Boston, MA.
On Wednesday November 12, 2025, at 1:20 PM EST, Aclaris’ President and Chief Operating Officer Dr. Hugh Davis and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Stifel 2025 Healthcare Conference in New York, NY.
On Monday November 17, 2025, at 2:00 PM GMT (9:00 AM EST), Dr. Walker will participate in a fireside chat during the Jefferies Global Healthcare Conference in London, UK.

Live and archived webcasts of these events will be accessible on the Events page of View Source The webcasts will be available on the Aclaris website for at least 30 days.

(Press release, Aclaris Therapeutics, OCT 29, 2025, View Source [SID1234657098])

Caris Data Validates TET2 Clonal Hematopoiesis as a Biomarker for Enhanced Immunotherapy Response

On October 29, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported collaborative new research identifying TET2 clonal hematopoiesis (CH) as a promising biomarker for improved response to immune checkpoint inhibitor (ICI) therapy in patients with solid tumors. The study titled, `TET2-mutant clonal hematopoiesis enhances macrophage antigen presentation and improves immune checkpoint therapy in solid tumors,’ was led by Padmanee Sharma, M.D., Ph.D. at the James P. Allison Institute at The University of Texas MD Anderson Cancer Center and published in Cancer Cell.

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The study’s purpose was to investigate how immune cells carrying CH-derived TET2 mutations influence solid tumor immunology and respond to ICI therapy. Dr. Sharma and Shelley Herbrich, Ph.D., postdoctoral fellow in Dr. Sharma’s lab, explored the underlying mechanisms using TET2-mutant laboratory models, which revealed how these mutations shape immune dynamics within the tumor microenvironment.

To validate the clinical relevance of these findings, the study leveraged Caris Life Sciences’ extensive clinico-genomic database, analyzing outcomes in a real-world cohort of nearly 36,000 patients with non-small cell lung cancer (NSCLC) and over 25,000 colorectal (CRC) cancer patients. This dual approach provided insight and large-scale evidence supporting TET2-CH as a potential biomarker for enhanced ICI response. Importantly, these findings represent a major observation that directly ties clonal hematopoiesis to therapy outcomes in solid tumors, suggesting a future role of CH for driving therapy selection.

"These findings represent a major step forward in understanding how clonal hematopoiesis influences cancer immunology," said Milan Radovich, Ph.D., Senior Vice President, Chief Scientific Officer at Caris. "It further demonstrates that we are only scratching the surface on the potential applications of CH, namely a novel function of CH as a predictive therapeutic biomarker that can be used to improve patient outcomes."

"These results are encouraging, highlighting TET2-mutated clonal hematopoiesis as a potential biomarker to select patients who are more likely to respond to immunotherapy," said Padmanee Sharma, M.D., Ph.D., professor of Immunology and Genitourinary Medical Oncology at MD Anderson and director of scientific programs for the Allison Institute.

(Press release, Caris Life Sciences, OCT 29, 2025, View Source [SID1234657118])

Cidara Therapeutics to Participate in November Investor Conferences

On October 28, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported that company management will participate in the below November investor conferences.

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Details are as follows:

Event: Guggenheim 2nd Annual Healthcare Innovation Conference
Date: November 11, 2025
Time: 8:00 AM ET
Format: Fireside Chat

Event: Jefferies London Healthcare Conference
Date: November 17, 2025
Time: 4:30 PM GMT
Format: Presentation

The live webcast for the events can be accessed in the Investors section on the Company’s website at View Source Replays of the presentations will be available for at least 30 days.

Cidara will also participate in one-on-one investor meetings during the conferences.

(Press release, Cidara Therapeutics, OCT 28, 2025, View Source [SID1234657063])

Harbour BioMed Launches First Fully Human Generative AI HCAb Model to Accelerate Next-Generation Biologics Discovery

On October 28, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported the launch of its first fully human Generative AI HCAb (Heavy Chain-Only Antibody) Model powered by its Hu-mAtrIx AI platform, built upon the Harbour Mice platform. This platform establishes a closed-loop process integrating AI design, intelligent screening, and wet-lab validation.

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The announcement was made at the company’s Global R&D Day 2025 event in Shanghai. During the event, the Global AI + Pharmaceutical Ecosystem Alliance was also officially launched. The alliance brings together leading expertise, cutting-edge technologies, and resources from various sectors, aiming to systematically reshape the entire drug R&D process through artificial intelligence technologies, accelerating the development of innovative therapies for the benefit of patients worldwide.

AI-Driven Precision for Faster and More Accurate Target Identification

The newly released AI HCAb Model establishes a closed-loop workflow that integrates AI-driven sequence generation, design and screening, and wet-lab validation. This end-to-end process transforms antibody discovery from blind screening to AI-driven intelligent selection, dramatically improving efficiency and accuracy in antibody discovery.

HCAb, known for its simple structure and low molecular weight, holds strong potential for advanced applications like bispecific/multi-specific antibodies, ADCs, CAR-T, and mRNA therapies. However, conventional human VH domains struggle to maintain stability without VL pairing.

Harbour BioMed’s Harbour Mice platform — the world’s first transgenic mouse platform that produces fully human functional HCAb — laid the foundation for overcoming this challenge. The key AI design lies in accurately identifying functional, autonomous HCAbs from vast datasets, given the high structural and sequential similarity between HCAb VH sequences and those of conventional (H2L2) antibodies. Harbour BioMed’s HCAb generation model is trained on 9 million NGS-derived HCAb sequences and extensive public data. Using a fine-tuned protein large language model, it enables de novo generation of high-potential HCAb sequences, with secondary optimization for target specificity.

These AI-generated sequences then undergo a multi-stage intelligent screening process, which includes:

AI Classification Model to filter non-HCAb sequences
Multimodal AI Developability Prediction Model (achieving SOTA performance) to assess key developability parameters such as stability, solubility, and aggregation tendency
Only candidates that pass rigorous screening proceed to synthesis and wet-lab validation.

AI HCAb Model Delivers Higher Binders Diversity and Binding Success Rate

The AI HCAb Model demonstrated a tenfold increase in candidate generation and significantly improved success rates. Data show that among 107 de novo generated binder sequences produced by AI HCAb model, 78.5% successfully hit the target, while 20 molecules were further validated in wet-lab assays, demonstrating high activity, purity, yield, and specificity.

These AI-designed binders demonstrated outstanding developability profiles, with an average yield exceeding 700 mg/L. Multiple candidate sequences showed nanomolar-level binding affinity while maintaining binding activity against relevant targets in both humans and cynomolgus monkeys.

Accelerating the Development of Next-Generation Therapies

Harbour BioMed’s AI platform is designed as a self-evolving innovation flywheel driven by continuous learning and feedback: AI design – automated validation – AI re-learning.

This iterative process enables generative AI to create diverse new molecules, while high-throughput automation rapidly characterizes and feeds back experimental data to continuously enhance model intelligence and R&D efficiency.

With this foundation, the AI HCAb Model is expected to accelerate applications of fully human HCAbs across next-generation therapeutic areas — including multi-specific antibodies, XDCs, in vivo CAR-T, and inhaled or oral large-molecule drugs — helping redefine the landscape of biologics discovery.

Building the Future AI + Pharmaceutical Ecosystem

At the event, Harbour BioMed also announced the official establishment of the Global AI + Pharmaceutical Ecosystem Alliance, which brings together leading experts, technology partners, and investors to reshape the entire drug discovery pipeline through AI innovation.

The alliance has gained strong support from government bodies, industry associations, and investors including Fortera Capital, Insilico Medicine, Molecular Mind, Evinova, INNOVEL, Fenglin Group, Taimei Technology, EClinCloud, Deep Intelligent Pharma, and Harbour BioMed.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, said: "The Global AI + Pharmaceutical Ecosystem Alliance aims to create an open, collaborative, and win–win ecosystem. Through shared value and collective innovation, we seek to address the toughest challenges in drug discovery and bring transformative therapies to patients faster and more effectively."

(Press release, Harbour BioMed, OCT 28, 2025, View Source [SID1234657079])

Domain Therapeutics Doses First Patients in Phase I / II Trial of DT-7012 Targeting CCR8 in Solid Tumors

On October 28, 2025 Domain Therapeutics ( "Domain" or "the Company" ), the GPCR experts harnessing deep receptor biology to develop breakthrough treatments for patients, reported that the first patients have been dosed in its Phase I / II DOMISOL clinical study of DT-7012, a differentiated Treg-depleting anti-CCR8 monoclonal antibody for the treatment of solid tumors.

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The DOMISOL study is an open-label, multicenter Phase I / II, first-in-human dose-escalation and cohort-expansion trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of DT-7012 in adult patients with selected advanced solid tumors. The trial is being conducted in Australia, with initial clinical sites including Peninsula and Southeast Oncology ( PASO ) and Cabrini Health in Melbourne. Additional centers are expected to come online in the coming months. For more information on the trial, visit: NCT06819735.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "CCR8 has rapidly emerged as a highly competitive target, drawing significant interest across the industry, including from leading pharmaceutical companies.
DT-7012 stands out with its unique and differentiating properties, offering unprecedented selectivity in depleting intratumoral Tregs while simultaneously improving overall immune system function. These features are critical for effective cancer immunotherapy, positioning DT-7012 as a promising candidate to overcome immune resistance and bring hope to patients with limited treatment options."

Professor Vinod Ganju, Principal Investigator at PASO, commented: "Immune checkpoint inhibitors ( ICIs ) have revolutionized cancer treatment, yet a significant unmet need remains as Tregs suppress immune response, driving resistance to ICIs and limiting their effectiveness. We are excited to participate in this important trial and offer patients access to a highly promising therapeutic candidate that could make Treg depletion a reality in cancer therapy.
DT-7012 adds to the growing momentum around CCR8, complementing another CCR8-targeting asset currently undergoing significant patient expansion."

"Dosing of the first patients in the DOMISOL trial represents a significant milestone, as DT-7012 becomes our second fully proprietary asset to enter the clinic, underscoring our proven ability to translate cutting-edge GPCR biology into high value differentiated products", added Sean A. MacDonald, Chief Executive Officer of Domain Therapeutics. "Initiating this trial in Australia aligns with our strategy to accelerate clinical development and strengthens momentum behind our pipeline of drug candidates. As we continue to advance our programs and deliver value for stakeholders, we are proud to contribute to the introduction of a potentially groundbreaking therapeutic solution that could transform lives of cancer patients worldwide."

(Press release, Domain Therapeutics, OCT 28, 2025, View Source [SID1234657064])