Coherus Oncology Announces Publication in Molecular Cancer Therapeutics Highlighting the Strong Pharmacology of Investigational CCR8 Antibody Tagmokitug (CHS-114)

On January 5, 2026 Coherus Oncology, Inc. (NASDAQ: CHRS) reported the publication of preclinical and clinical biomarker research in Molecular Cancer Therapeutics describing the high selectivity, picomolar binding affinity and significant effector mediated killing of CCR8+ cells of its investigational anti-CCR8 monoclonal antibody. The findings show that the antibody, now named tagmokitug, demonstrated no off-target binding, and selectively eliminates CCR8+ T regulatory cells and not other T cells, supporting its potential as an anticancer treatment. The full article may be accessed in the December 2025 issue of Molecular Cancer Therapeutics.

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The publication provides important scientific evidence for the program and supports the ongoing advancement of tagmokitug in clinical studies evaluating its antitumor activity across multiple solid tumor settings in combination with toripalimab.

"This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells. These data provide evidence that tagmokitug has the potential for a differentiated profile," said Theresa LaVallee, PhD, Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program. We look forward to advancing the development as we continue to explore tagmokitug in patients with solid tumors."

Key highlights from this publication include:

CCR8 is highly abundant and preferentially over expressed in Treg cells in solid tumors and that most solid tumors have a high level of CCR8.

Anti-tumor and tumor immune remodeling activity of anti-CCR8 antibody treatment was observed in mouse tumor models and activity was enhanced with anti-PD-1 antibody combination treatment.

Tagmokitug has robust characteristics with picomolar binding affinity, exquisite selectivity for CCR8 with no off target binding and potent target cell killing by a bind and kill mechanism that induces tumor regression in mice.

In the first-in-human clinical study, proof of mechanism is established with translational data showing tagmokitug administration leads to selective reductions in CCR8+ Tregs and not other T cell subsets in cancer patients.

About Tagmokitug

Tagmokitug is an investigational monoclonal antibody that selectively targets CCR8, a receptor highly enriched on regulatory T cells within the tumor microenvironment. Tagmokitug is currently being evaluated in Phase 1b/2a clinical trials in patients with solid tumors in combination with the PD-1 inhibitor toripalimab and chemotherapy. It is part of Coherus Oncology’s next-generation immunotherapy pipeline being evaluated across multiple solid tumor settings.

(Press release, Coherus Oncology, JAN 5, 2026, View Source [SID1234661710])

Circle Pharma to Present at the 44th Annual J.P. Morgan Healthcare Conference

On January 5, 2026 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported that David J. Earp, J.D., Ph.D., president and chief executive officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 5:00 p.m. PT.

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Dr. Earp will provide an overview of the company’s pipeline, including CID-078, a first-in-class oral macrocyclic cyclin A/B RxL inhibitor in Phase 1 clinical development for patients with advanced solid tumors, and CID-165, a first-in-class oral macrocyclic cyclin D1 RxL inhibitor, with potential applications in malignancies, including ER-positive breast cancer and lymphomas.

(Press release, Circle Pharma, JAN 5, 2026, View Source [SID1234661709])

Ascendis Pharma to Participate in the 44th Annual J.P. Morgan Healthcare Conference

On January 5, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in the 44th Annual J.P. Morgan Healthcare Conference and provide a business update on Monday, January 12, 2026, at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time in San Francisco, California.

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A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

(Press release, Ascendis Pharma, JAN 5, 2026, View Source [SID1234661708])

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT® for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

On January 5, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported the submission of the first module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA), following the FDA’s previous decision to allow the Company to use the more flexible modular approach. The Company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application.

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Uzi Sofer, CEO of Alpha Tau, stated, "Alpha Tau continues its fast pace of activity, charging forward in our pursuit of potential marketing authorizations across a wide range of tumors, with an eye toward future commercialization. The decision by the FDA to allow us to submit our PMA in a modular form will hopefully allow for ongoing FDA review and feedback as each module is submitted, and we look forward to this dynamic and efficient authorization review process with the FDA."

Yaniv Sagie, VP Quality and Regulatory Affairs, added, "Thank you to our outstanding team for this great accomplishment, our first PMA module submission, and for all of the other achievements working with regulators around the world. I appreciate the support of our advisors who work closely with us and hope to accomplish great things for Alpha Tau together."

Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme (GBM) and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program (TAP) to accelerate market access for the potential treatment of recurrent GBM.

(Press release, Alpha Tau Medical, JAN 5, 2026, View Source [SID1234661707])

Agios to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026

On January 5, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported that its management team is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 8:15 a.m. PST / 11:15 a.m. EST.

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

(Press release, Agios Pharmaceuticals, JAN 5, 2026, View Source [SID1234661706])