On February 1, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported a collaboration with Shanghai Junshi Biosciences, Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) for the development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada (Press release, Coherus Biosciences, FEB 1, 2021, View Source [SID1234574456]). Upon satisfaction of closing conditions, Coherus and Junshi Biosciences will co-develop toripalimab, and Coherus will be responsible for all commercial activities in the licensed territory. Under the terms of the agreement, Coherus will also be granted options to Junshi Biosciences’ TIGIT-targeted antibody and next generation engineered IL-2 cytokine for evaluation as potential combination therapies with toripalimab, as well as certain negotiation rights to two early-stage checkpoint inhibitor antibodies.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Toripalimab has a compelling late-stage clinical profile and will be the cornerstone of our immuno-oncology franchise. This transaction expands our late-stage pipeline into the rapidly growing checkpoint inhibitor market, which is expected to exceed $25 billion in the United States by 2025, and provides us a PD-1 backbone for potential long-term growth with next-generation immuno-oncology combinations," said Denny Lanfear, CEO of Coherus. "Junshi Biosciences is an innovation-driven biopharmaceutical company with global clinical research capabilities, and we are excited to collaborate with them as we build on our success in oncology with biosimilars and broaden our mission of expanding patient access and delivering health care system savings to larger markets."
"We believe Coherus is the right partner for us in North America. Their commercial team has demonstrated remarkable ability to gain significant share of the oncology market against entrenched large competitors," said Dr. Ning LI, CEO of Junshi Biosciences. "Toripalimab could be the first marketed Chinese anti-PD-1 antibody in the overseas market. The collaboration with Coherus will be a critical step to build up our global commercial network. We look forward to working closely with Coherus to establish toripalimab’s position in the United States and Canadian markets in order to provide patients with affordable high-quality innovative care."
More than 2,100 patients have received toripalimab treatment in clinical trials, and toripalimab is approved for second-line treatment of unresectable or metastatic melanoma in China where it is marketed by Junshi Biosciences and is included on the National Reimbursement Drug List ("NRDL") for the treatment of melanoma. Over the next three years, significant data are expected to read out from the extensive registrational development program, which includes 15 ongoing and completed pivotal clinical trials evaluating toripalimab in multiple treatment settings for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
The United States Food and Drug Administration ("FDA") has granted breakthrough therapy designation to toripalimab for 3rd line nasopharyngeal carcinoma ("NPC"), and Coherus expects the first toripalimab biologics license application ("BLA") to be filed with the FDA for this indication later this year. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma, and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer ("NSCLC").
As part of the collaboration, Coherus will also be granted options and certain negotiation rights to four of Junshi Biosciences’ novel oncology molecules for potential development in combination with toripalimab:
JS006, an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated synergistic anti-tumor activity in combination with anti-PD-1 antibodies. Coherus expects this compound to enter clinical development later this year. The option to JS006 is exercisable prior to initiation of Phase 2 clinical development.
JS018, a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer ("NK") cells. The option to JS018 is exercisable prior to initiation of Phase 2 clinical development.
Two additional undisclosed early-stage novel immuno-oncology drug candidates to which Coherus will also be granted certain negotiation rights.
Mr. Lanfear provided further comment on Coherus’ corporate strategy: "We plan to invest the cash generated by our biosimilar commercial business to build a focused immuno-oncology franchise, which will leverage our development and commercial capabilities into large and growing markets. We will prudently allocate our R&D resources to realize the exciting potential of toripalimab in both the monotherapy and combination settings. With respect to biosimilars, our focus will be commercialization, as we continue to pursue UDENYCA market share growth and prepare for projected launches through 2023 of biosimilars of Humira, Avastin and Lucentis, if approved."
Coherus is discontinuing the development of CHS-2020 (Eylea biosimilar candidate) and will direct those capital and development resources to the toripalimab monotherapy and combinations program.
Terms of the Coherus – Junshi Biosciences collaboration
Under the terms of the agreement, Coherus will pay $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones, including up to $290 million for attainment of certain sales thresholds. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones, including up to $170 million for attainment of certain sales thresholds. The Companies will collaborate in the development of toripalimab and the other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.
Closing of the collaboration agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act.
Jonathan Lanfear of Lanfear Advisors LLC led negotiations on behalf of Coherus, and Ropes & Gray LLP provided licensee’s legal counsel.
Conference call at 8:00 am Eastern Time
Webcast: The conference call will be broadcast live in listen-only mode on the Company’s investor relations website at View Source If you would like to ask a question, the dial in number for the conference call is (844) 452-6826 (Toll Free U.S. and Canada) or (765) 507-2587 (International).
Conference ID: 7784059
Please dial-in 15 minutes early to ensure a timely connection to the call.
A link to the conference call replay will be available on the Coherus website for two weeks following the call.
About toripalimab (approved in China as TUOYI)
Toripalimab is the first Chinese domestic anti-PD-1 monoclonal antibody to obtain a marketing approval in China. More than thirty company-sponsored toripalimab clinical studies covering more than 15 indications have been conducted globally, including in China and the United States. In December 2018, toripalimab obtained a conditional approval from China’s National Medical Products Administration ("NMPA") for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, toripalimab was included in the NRDL for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).
In the United States, the FDA has granted toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.
About the toripalimab clinical development program
Toripalimab is being evaluated in an extensive registrational clinical development program for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma (POLARIS-01) – NCT03013101
Phase 1b/2 trial Evaluating Toripalimab in Patients with Advanced Gastric Adenocarcinoma, ESCC, NPC and Head and Neck Squamous Cell Carcinoma (POLARIS-02) – NCT02915432
Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma (POLARIS-03) – NCT03113266
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive for Specific Markers – NCT04603040
Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer – NCT03581786
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Curative Hepatic Resection (JUPITER-04) – NCT03859128
A Phase III Study to Investigate Toripalimab Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma (JS001) – NCT03430297
A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC (CHOICE-01) – NCT03856411
Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (JUPITER-06) – NCT03829969
Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lung cancer Patients Previously Treated with EGFR-TKI – NCT03924050
Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT) – NCT04085276
Phase 3 Trial Comparing Toripalimab + Lenvatinib vs. Lenvatinib Alone as a 1st line Treatment for Patients with Advanced HCC – NCT04523493
Toripalimab in Combination With Platinum Plus Etoposide in Patients With Extensive-Stage Small Cell Lung Cancer – NCT04012606
A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC – NCT04158440
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer – NCT04394975
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma – NCT04568304
About JS006
JS006 is a recombinant humanized IgG4κ monoclonal antibody against human TIGIT specifically, developed independently by Junshi Biosciences. According to the results of preclinical studies, JS006 can specifically block the TIGIT-PVR pathway.
About JS018
JS018 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer ("NK") cells.