Announcement • Jul 28
Corbus Pharmaceuticals Announces FDA Clearance to Initiate Tempo-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer Corbus Pharmaceuticals Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study (“TEMPO-1”) of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study's primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval. The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone. The FDA's decision to allow the registrational study to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing). CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. Announcement • Jul 06
Corbus Pharmaceuticals Holdings, Inc. Announces Appointment of Leonardo Viana Nicacio as Chief Medical Officer Corbus Pharmaceuticals Holdings, Inc. announced the appointment of Leonardo Viana Nicacio, M.D., as Chief Medical Officer. Dr. Nicacio’s career spans over 20 years in the pharmaceutical industry. Prior to joining Corbus, he was the Chief Medical Officer at Protara Therapeutics, a clinical-stage company developing therapies for the treatment of cancer and rare diseases. Prior to Protara, Dr. Nicacio served as Senior Vice President, Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics, a subsidiary of the Menarini Group, where he was responsible for establishing and executing global strategies for solid tumor development. From 2017 to 2023, he held roles of increasing responsibility at Seagen (acquired by Pfizer in December 2023), most recently as Vice President of Clinical Development, overseeing programs across a range of cancers, including bladder, breast, gynecologic, lung, colorectal, and head and neck cancers, and most notably worked on a therapeutic for metastatic cervical cancer, TIVDAK®. Earlier in his career, Dr. Nicacio served as Senior Global Medical Lead in Global Medical Affairs at AstraZeneca, where he played an integral role in clinical, regulatory, and launch preparation activities leading up to the approval of durvalumab in bladder cancer. He also held leadership roles at Flatiron Health, where he was instrumental in building the first health technology platform focused on organizing real-world oncology data. Additionally, Dr. Nicacio held positions at Sanofi and YM Biosciences. Dr. Nicacio holds a Medical Degree from Faculdade de Ciências Médicas de Minas Gerais in Brazil and completed a molecular biology fellowship at the New York Blood Center. He is board-certified in internal medicine and medical oncology and has published extensively in top medical journals. Dr. Nicacio is an active member of the American Society of Clinical Oncology and the European Society of Medical Oncology. Announcement • May 26
Corbus Pharmaceuticals Holdings, Inc. Reports Updated Clinical Data For CRB-701 Phase 1/2 Study In Oropharyngeal And Cervical Cancers Corbus Pharmaceuticals Holdings, Inc. reported updated data from its Phase 1/2 clinical study (NCT06265727)of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC). The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. These findings will be presented at the upcoming 2026 American Society for Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2026, in Chicago. The ongoing multi-center Phase 1/2 study is being conducted in the U.S. and Europe. The data reported now derives from an April 1, 2026 data cut of the Phase 1/2 study with a total safety population of 317 patients encompassing all tumor types and all doses. A total of 75 patients with HNSCC were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 71 were efficacy evaluable while 4 did not have post-baseline scans. A total of 72 patients with cervical cancer were enrolled at the 2.7 mg/kg and 3.6 mg/kg doses, of whom 70 were efficacy evaluable while 2 did not have post-baseline scans. CRB-701 continued to be safe and well tolerated, consistent with findings reported at the ESMO 2025 data cut. The most common treatment-related adverse events (TRAEs) occurring in more than 20% of participants were keratitis (49.2%), alopecia (25.6%), fatigue (22.4%), and dysgeusia (19.9%). Grade 3 adverse events (AEs) were reported in 19.2% of patients, and Grade 4 AEs were reported in 0.9% of patients. There were no Grade 5 events reported. The incidence of peripheral neuropathy remained low at 7.3%, with all events limited to Grade 1 or 2 severity. Skin-related AEs, excluding alopecia, were at 24%. There was only one Grade 3 event (0.3%) reported. There were no skin Grade 4 or 5 events, and no reported cases of Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN). Overall, treatment discontinuations related to CRB-701 remained low at 2.8%. Ocular toxicities, a well-established side effect in multiple approved ADCs, continued to be manageable through prophylactic eye care interventions and dose reductions/interruptions. Ocular AEs were reported in 66.2% of participants, with the vast majority being transient in nature. Grade 3 events were reported in 12.6% of participants and only one Grade 4 event (0.3%) was reported involving exacerbation of pre-existing punctate keratitis and microcysts that resolved to baseline within six weeks. Discontinuations due to ocular AEs remained markedly low at 1.9%.
Corbus is on track to initiate a registrational study of CRB-701 in 2L OPSCC (“TEMPO-1”) in the summer of 2026. Broad alignment was reached with the U.S. Food and Drug Administration (FDA) on the trial design for a randomized controlled study (n=250), which will explore the efficacy and safety of CRB-701 compared to investigator’s choice of monotherapy with overall response rate (ORR) as the primary endpoint for potential accelerated approval and potential full approval based on overall survival (OS) benefit. Similarly, broad alignment was reached with the FDA regarding the trial design for a randomized controlled study of CRB-701 in 2L cervical cancer. 
