Coherus Oncology Inc (CHRS) News & EventsCHRSCoherus Oncology Inc

Coherus Oncology Reports Tagmokitug Clinical Data, cORR Reaches 89% in ESCC Patients

Coherus Oncology announced interim clinical data from the TREGCHECK development program evaluating tagmokitug, its investigational cytolytic CCR8 antibody, in combination with toripalimab, with or without chemotherapy. Tagmokitug-based treatment demonstrated encouraging anti-tumor activity across multiple solid tumors, including responses and durable disease stabilization in pretreated and immunotherapy-resistant patients. In evaluable front-line esophageal squamous cell carcinoma, or ESCC, patients, tagmokitug in combination with toripalimab and chemotherapy demonstrated a confirmed overall response rate, or cORR, of 75% irrespective of PD-L1 status, and a cORR of 100% in PD-L1 positive patients as of October 14. Subsequent to the data cutoff date, two additional partial responses were confirmed, increasing the cORR to 89% of the evaluable patient dataset. Activity and duration of response in second-line ESCC patients, as well as an acceptable and manageable safety profile, support the selected dose and expansion of enrollment in both ESCC cohorts. The totality of the interim clinical activity, dose-response findings and safety observations support continued development of tagmokitug and expansion of the first-line and second-line ESCC cohorts. Patients with previously untreated advanced or metastatic ESCC received tagmokitug 700 mg plus toripalimab, 5-fluorouracil and cisplatin. The primary endpoint is safety; secondary endpoints include ORR, duration of response, clinical benefit rate and progression-free survival. As of October 14, 2026, 10 patients were safety evaluable and 8 were efficacy evaluable, and enrollment is ongoing. Patients with recurrent or metastatic ESCC who failed first-line systemic chemotherapy with or without a PD-1 inhibitor were randomized 1:1 to tagmokitug 300 mg or 700 mg plus toripalimab. As of October 14, 17 patients were safety evaluable and 8 were efficacy evaluable and enrollment is ongoing. Tagmokitug demonstrated a manageable safety profile across the TREGCHECK clinical program. In 33 patients with monotherapy, no dose-limiting toxicities were observed through the 1200 mg every-three-week dose level, and no Grade 5 treatment-related adverse events were reported. In more than 120 patients treated with tagmokitug in combination with toripalimab, no new safety signals beyond those associated with PD-1/immune checkpoint inhibitor therapy were identified. Most adverse events were Grade 1 or 2 and resolved, and safety was comparable across tagmokitug dose levels. Among 120 patients treated with tagmokitug plus toripalimab, the overall rate of immune-related adverse events was 40%, with 20% experiencing Grade 3-5 irAEs. The most commonly reported TRAEs were infusion-related reactions, fatigue and rash. No Grade 5 treatment-related adverse events were reported. In the first-line ESCC cohort, 10 patients treated with tagmokitug in combination with toripalimab and chemotherapy demonstrated a manageable safety profile, with no new safety signals or Grade 5 treatment-emergent adverse events observed. Most adverse events were attributed to chemotherapy and the treatment discontinuation rate is similar to the approved regimens for PD-1 inhibitors with chemotherapy. Based on the interim findings, Coherus plans to expand enrollment in first-line and second-line ESCC and continue to evaluate the durability of response, progression-free survival and biomarker findings across indications as the data mature. Coherus is also advancing tagmokitug in combinations beyond PD-1 inhibition, including a planned study evaluating the safety of tagmokitug with a T-cell engager in mCRPC.

Coherus Oncology Initiates Sale of Biosimilars Assets

Coherus Oncology has initiated the process to market and sell the remaining assets associated with the Company's former biosimilars business. The Company has retained Oppenheimer & Co. to serve as its financial advisor in connection with the sale. As previously announced on August 17, the Company declared a special dividend of contingent value rights, which will be distributed pro rata to stockholders of record of the Company's common stock as of September 30, with distribution occurring on October 7. CVR holders are entitled to receive their pro rata share of any net cash proceeds, and the net cash value of any other consideration, actually received by the Company from third parties in connection with the sale of the Legacy BioSim Assets or as licensing fees under any licensing agreement covering the Legacy BioSim Assets. The Legacy BioSim Assets include: Patents and other intellectual property; Royalties under an existing license agreement; Cell lines; Related materials, including laboratory notebooks, regulatory filings, and product samples. To be eligible to receive the CVRs, an investor must be a stockholder of record of the Company's common stock as of the Record Date. Investors should contact their brokers with any questions regarding their holder status as of the Record Date.

Q2 Revenue at $14.31M, Below Consensus

Reports Q2 revenue $14.31M, consensus $20.44M. "During the second quarter we continued to pursue our science-driven clinical development strategy, creating multiple avenues for long-term value creation, and look forward to further maturation of data with both tagmokitug and casdozokitug," said Denny Lanfear, Chairman and Chief Executive Officer.