Nasopharyngeal Carcinoma

– CHS-114 demonstrates clinical efficacy and proof of mechanism in HNSCC in combination with toripalimab – – Confirmed partial response in heavily pretreated PD-1 refractory patient supports expansion in HNSCC and gastric cancer in combination with toripalimab – – A second-line Phase 1 dose optimization study in HNSCC and gastric cancer is ongoing; results expected in the first half of 2026– – Coherus to host investor and analyst call with study investigator, Dr. Douglas Adkins, Washington University, today at 4:30 p.m. Eastern Time– REDWOOD CITY, CA, USA I April 28, 2025 I Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS), today announced data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization. These data are being presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois. The data showed a confirmed partial response in a heavily pretreated PD-1 refractory patient, a > 50% depletion in CCR8+ Treg, and an increase in CD8+ T cells, consistent with anti-tumor activity and demonstrating proof of mechanism. Importantly, the safety profile was consistent with advanced disease and the known safety profile of toripalimab. These data support continued evaluation of CHS-114 in combination with other therapies, including toripalimab. Results support advancement and ongoing enrolment in Part 3 of the study evaluating CHS-114 with toripalimab in HNSCC (n = 40). CHS-114 is an afucosylated CCR8 monoclonal antibody and is the only known selective molecule designed to exclusively target human CCR8 with no off-target binding and preferentially kills CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. “The data to date demonstrate a robust depletion of Treg cells in tumors, with a manageable safety profile, and a patient with a meaningful clinical response, which is highly encouraging,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “Furthermore, the profound increase in CD8+ T cells, making these tumors immunologically hot, is exciting as it supports CHS-114 being combined with several treatment modalities including T Cell Engagers. Head and neck cancer is an important strategic focus for Coherus, but CHS-114 has the potential, based on its mechanism of action, to treat many solid tumors, including non-small cell lung cancer and other large, underserved immuno-oncology indications, like colorectal cancer. We look forward to sharing further head and neck and gastric cancer data in the first half of next year.” “One of the biggest challenges in oncology has been finding a treatment that depletes Treg cells and relieves immune suppression in the tumor without causing collateral autoimmune disease or affecting antitumor T cells,” said Douglas Adkins, M.D., Professor of Medicine, Director, Section of Head and Neck and Thyroid Medical Oncology, Division of Medical Oncology, Washington University School of Medicine. “These early clinical results are exactly what we’ve been hoping for and demonstrate CHS-114’s ability to remodel the tumor microenvironment in favor of anti-tumor activity. I am looking forward to exploring this treatment combination for solid tumor patients, even beyond head and neck.” Results from Phase 1b dose expansion trial evaluating CHS-114 monotherapy and with toripalimab in HNSCC This open-label Phase 1b clinical trial evaluated CHS-114 as a single-agent and in combination with toripalimab in 21 patients with advanced solid tumors including HNSCC. Patients received either CHS-114 alone or in combination with toripalimab (240 mg) q3w. The primary endpoint of the study was to determine dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs), with the goal of identifying two recommended doses for expansion. Key secondary endpoints included objective response rate (ORR) based on investigator review per RECIST v1.1 as well as pharmacokinetics and pharmacodynamics (PK/PD). As of the data cutoff date of January 24, 2025: These results support continued evaluation of CHS-114 in combination with other drugs including toripalimab, with broad potential applications in many solid tumors with a high density of CCR8+ Treg cells. A second-line HNSCC dose optimization study of CHS-114 in combination with toripalimab in HNSCC and gastric cancer patients is ongoing, with anticipated results in the first half of 2026 The current study design is expected to address the regulatory requirements under Project Optimus 1 and support the recommendation of a phase 2 dose by early 2026. AACR 2025 Presentation Details Title: Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors Lead Author: Francis Worden, M.D., University of Michigan Abstract #: CT038 Poster Session: Phase 0 and Phase 1 Clinical Trials Poster Section 49: Poster board 17 Date and Time: Monday, April 28, 2025, 9:00 a.m. – 12:00 p.m. CDT Conference Call Information for Investors and Analysts Coherus Chief Development Officer, Dr. Theresa LaVallee, and Chief Medical Officer, Dr. Rosh Dias, will host a presentation and discussion of new clinical data from the Phase 1 study with CHS-114 with and without anti-PD-1 antibody toripalimab with study investigator, Dr. Douglas Adkins of Washington University. When: Monday, April 28, 2025, starting at 4:30 p.m. Eastern Time Investors and analysts are invited to listen into a live audio webcast of the presentation. To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register-conf.media-server.com/register/BI5eb6be782f004f9bb4e652903aabafe4 Please dial in 15 minutes early to ensure a timely connection to the call. Webcast: https://edge.media-server.com/mmc/p/yawixgnq An archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations . About the CHS-114 Phase 1 Study The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 12 HNSCC patients with paired tumor biopsies. Arm 2 evaluated two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with toripalimab. Secondary objectives were to evaluate the safety, PK, and antitumor activity of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers. About CHS-114 CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643) and gastric cancer (NCT06657144). About Coherus BioSciences Coherus 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 pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our 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 multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors including in non-small cell lung cancer and in hepatocellular carcinoma. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1 studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma and gastric cancer. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com . SOURCE: Coherus BioSciences

The PD-1 inhibitor Anniko marks Akeso’s first innovative medicine to receive FDA approval. Akeso is on a winning streak.Following a positive readout for its closely watched PD-1xVEGF bispecific ivonescimab, Akeso has won the FDA’s go-ahead for its PD-1 inhibitor penpulimab co-developed with Sino Biopharmaceutical’s Chia Tai-Tianqing Pharmaceutical.To be marked as Anniko, penpulimab is approved alongside chemotherapy for the first-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma, or as a single agent in patients who have tried platinum-based chemo and at least one other prior line of therapy.As Akeso noted Thursday, Anniko marks the company’s first innovative medicine to receive FDA approval. Previously, the drug has been approved in China for nasopharyngeal carcinoma, a rare cancer that develops in the nasopharynx, the upper part of the throat at the back of the nose. A separate application for Anniko in combination with Sino Biopharm’s VEGFR2 inhibitor anlotinib in first-line liver cancer is under review with Chinese authorities.About 10 PD-1/L1 inhibitors have reached the U.S. market before Akeso. The FDA nod puts Anniko in direct competition with Coherus BioSciences and Junshi Biosciences’ fellow China-made PD-1 Loqtorzi, which became the first FDA-approved therapy for nasopharyngeal carcinoma in 2023.The two Anniko indications are based on the international phase 3 AK105-304 trial and the pivotal AK105-202 study.In the phase 3 trial, Anniko’s chemo combination reduced the risk of progression or death by 55% versus chemo alone in the first-line setting, according to the FDA. Patients in the Anniko arm lived without progression for a median 9.6 months, which is significantly longer than the 7 months recorded by the control arm.Overall survival, a key secondary endpoint, was immature at the time of analysis, with 70% of prespecified deaths for the final analysis reported. According to the FDA, there was no sign of detriment to patients’ lives at this point. The full data from AK105-304 will be presented at the 2025 American Association for Cancer Research annual meeting in the following days. Previously, Loqtorzi got its first-line nod after showing its cocktail with chemo could significantly reduce the risk of death by 37% versus chemo alone in a phase 3 trial.As to the single-arm, China-only AK105-202 trial, Anniko triggered a 28% objective response rate in pretreated patients, and the median duration of response was not reached at the time of the analysis.Recurrent or metastatic nasopharyngeal carcinoma is not a large business opportunity. Citing a WHO 2020 analysis, Akeso noted that 133,000 new nasopharyngeal cancer cases are diagnosed annually worldwide, with 70% at a locally advanced stage. After an official rollout in the U.S. at the beginning of 2024, Coherus recorded $19.1 million Loqtorzi sales last year.According to the American Cancer Society, there is fewer than one case for every 100,000 people each year in the U.S., though it has higher rates in certain other countries, notably in South Asia. But the approval “highlights the quality of our innovation” and “underscores Akeso’s focus on delivering treatments for difficult-to-treat cancers for patients around the world,” Akeso CEO Michelle Xia, Ph.D., said in a statement. Despite Anniko’s breakthrough for Akeso on the international market, investors’ focus remains on the company’s Summit Therapeutics-partnered PD-1xVEGF bispecific ivonescimab, which has shown potential to replace Merck & Co.’s PD-1 blockbuster Keytruda as the new immunotherapy king in non-small cell lung cancer.Earlier this week, Akeso said the phase 3 HARMONi-6 trial in China found that ivonescimab and chemo did significantly better than BeiGene’s PD-1 inhibitor Tevimbra and chemo on progression-free survival for the first-line treatment of squamous NSCLC.That latest positive trial proves that ivonescimab’s head-to-head win against Keytruda as NSCLC monotherapies in the HARMONi-2 study was not a “one hit wonder,” Citi analyst Yigal Nochomovitz, Ph.D., said in a note.

SHANGHAI, April 25, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“NDA”) for toripalimab (trade name: TUOYI®) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration (“NMPA”). This marks the approval of toripalimab’s 12th indication in the Chinese mainland. Melanoma is the most malignant type of skin cancer. According to GLOBOCAN 2022 statistics, approximately 332,000 new melanoma cases and 59,000 deaths were recorded globally that year. Though melanoma is relatively uncommon in China, its mortality rate is high (approximately 5,000 deaths amongst approximately 9,000 new cases in 2022) and its incidence rate is rising year by year. Since 2018, anti-PD-1 monoclonal antibodies have been approved for the second-line or later treatment of advanced melanoma in China and are widely used clinically. However, the first-line standard treatment for advanced melanoma is still dominated by traditional chemotherapy or targeted therapy (limited to patients with BRAF V600 mutation). Until now, no domestic anti-PD-1 monoclonal antibody had been approved for advanced melanoma in China, creating an urgent clinical need for first-line immunotherapy options. The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297). MELATORCH is a multicenter, randomized, open-label, positive-controlled Phase 3 clinical study, and is also the first pivotal registrational clinical study of a PD-(L)1 inhibitor as the first-line treatment for advanced melanoma that has yielded positive results. Led by Professor Jun GUO from Peking University Cancer Hospital as the Principal Investigator, the study was conducted in 11 clinical centers across the country. The study was designed to compare the efficacy and safety of toripalimab versus dacarbazine for the systemic anti-tumor treatment-naive patients with unresectable or metastatic melanoma. Prior to this, the results of the MELATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. The results showed that compared with the dacarbazine group (N=128), the progression-free survival (“PFS”) assessed by Blinded Independent Central Review (BICR) of the toripalimab group (N=127) was significantly prolonged, with the median PFS of the two groups being 2.3 months vs. 2.1 months respectively, and the disease progression or mortality risk was reduced by 29.2% (hazard ratio [HR]=0.708, 95% CI: 0.526-0.954; P=0.0209). The sensitivity analysis of median overall survival (“OS”), corrected for the impact of subsequent anti-tumor treatment, showed that compared with the dacarbazine group, the toripalimab treatment group showed a significant trend towards survival benefit, with the median OS being 15.1 months vs. 9.4 months (HR=0.680, 95% CI: 0.486-0.951) respectively. Toripalimab has a good safety profile that is consistent with previous studies with no new safety signals identified. Professor Jun GUO from Peking University Cancer Hospital said, “Melanoma is a highly aggressive cancer. Due to its low sensitivity to traditional radiotherapy and chemotherapy, patients are often faced with poor survival outcomes. However, thanks to melanoma’s high immunogenicity, immunotherapies such as toripalimab have significantly improved patient survival in recent years. In China, advanced melanoma patients—including those in second-line and later—have gained broad access to these treatments through national medical insurance. Now, toripalimab has been extended to first-line treatment of advanced melanoma. Compared to traditional chemotherapy, toripalimab has demonstrated significant advantages in PFS, ORR, and DoR, as well as a clear trend toward improved OS. Notably, this approval was based on the MELATORCH study, which exclusively enrolled Chinese patients. The trial design aligned closely with clinical practice in China, and thus the findings were more relevant to Chinese melanoma patients. We hope that China’s independently developed immunotherapies like toripalimab can provide a comprehensive treatment solution for advanced melanoma and offer new hope to more patients.” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, also shared her enthusiasm: “Within a month, toripalimab has secured approvals for two new indications—liver cancer and melanoma. This milestone achievement was, without a doubt, made possible by the selfless and dedicated collaboration of researchers, participating patients, and R&D teams. Seven years ago, toripalimab had just pioneered breakthroughs in second-line melanoma treatment, becoming China’s first domestically developed anti-PD-1 monoclonal antibody and starting a new era of immunotherapy in China; today, toripalimab is again reaching new heights as it becomes the first Chinese-developed first-line immunotherapy for melanoma. Not only does this demonstrate toripalimab’s exceptional clinical value, it also reflects China’s growing strength and innovation in immuno-oncology. Moving forward, we will remain committed to advancing world-class therapies to benefit patients across the world!” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;first-line treatment for unresectable or metastatic melanoma. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800