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-Coherus Oncology formally introduces non-proprietary name: tagmokitug-
-Publication shows picomolar affinity for CCR8 with no off-target binding and proof-of- mechanism in preclinical and clinical studies-
-Data show CCR8 target is present with high prevalence and density in many solid tumors-
Coherus Oncology, Inc. (NASDAQ: CHRS) today announced 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.
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.
About Coherus Oncology
Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), growing revenues and a promising proprietary pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, colorectal and other cancers. The Company's strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both its pipeline candidates as well as its partners, driving sales multiples and synergies from proprietary combinations.
Coherus' immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in a randomized Phase 2 study in patients with HCC. Tagmokitug (CHS-114) is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b/2a studies in patients with advanced solid tumors, including head and neck cancer, colorectal cancer, gastric cancer, and esophageal cancer.
Forward-Looking Statements
The statements in this press release include express or implied forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended about Coherus that involve risks and uncertainties relating to future events and the future performance of Coherus. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "future," "opportunity," "likely," "target," variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions.
Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the ability of Coherus' pipeline to enhance outcomes for cancer patients; expectations about future synergies; projections about growth in sales; expectations for future enrollment in clinical trials; projections about the expansion of indications for LOQTORZI; and the assumptions underlying or relating to such statements.
These forward-looking statements are based on Coherus' current plans, estimates and projections. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those contemplated in any forward-looking statements. Such risks and uncertainties include, without limitation: uncertainties about the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on Coherus' prospects, business and operations in the future; risks and uncertainties in executing collaboration agreements and other joint ventures; risks and uncertainties of conducting clinical trials; the risks of Coherus' dependence on an ability to raise funds, which may not be available on acceptable terms or at all; and risks and uncertainties of any litigation, regulatory actions and other legal proceedings.
All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further discussion of these and other factors that could cause Coherus' future results to differ materially from any forward-looking statements see the section entitled "Risk Factors" in Coherus' Quarterly Report on Form 10-Q for the period ended September30, 2025, filed with the Securities and Exchange Commission (SEC) on November 6, 2025, as updated by Coherus' subsequent reports filed with the SEC.
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Coherus Oncology Contact Information:
For Investors:
Carrie Graham
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IR@coherus.com
