, /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non- small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non- ex20ins EGFR mutations and CNS involvement. Data will be presented at the European Society fo ...

Company Overview - Cullinan Therapeutics, Inc. (NASDAQ: CGEM) is a biopharmaceutical company that employs a modality-agnostic approach to drug development, targeting biological mechanisms in oncology and autoimmune conditions [1] Business Strategy - The company selects the most effective modality for each therapeutic target, indicating a flexible strategy that adapts to various treatment needs [1] Partnerships - Cullinan Therapeutics engages in partnerships to enhance its drug development capabilities, which may provide additional resources and expertise [1]

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced positive results from the REZILIENT1 trial for zipalertinib in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations [1][4] - The trial results will be presented at the 2025 ASCO Annual Meeting [1] Company Overview - Taiho Oncology specializes in developing and commercializing orally administered anti-cancer agents, focusing on solid tumors and hematological malignancies [9] - Cullinan Therapeutics is dedicated to creating new standards of care in cancer and autoimmune diseases, with a diversified portfolio of clinical-stage assets [11] Clinical Trial Details - REZILIENT1 is a Phase 1/2 global study evaluating the efficacy and safety of zipalertinib in patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations [5] - The primary endpoints of the trial were overall response rate (ORR) and duration of response (DOR) [5] Efficacy Results - Zipalertinib demonstrated a confirmed ORR of 35.2% overall, with a median DOR of 8.8 months and progression-free survival of 9.4 months [8] - In patients who received prior platinum-based chemotherapy, the ORR was 40% with a median DOR of 8.8 months [8] - Subgroup analyses showed a confirmed ORR of 30% and median DOR of 14.7 months in patients who had prior amivantamab [8] Safety Profile - The safety profile of zipalertinib was manageable and consistent with previously reported data [8]

Core Insights - Cullinan Therapeutics has received approval from the European Medicines Agency (EMA) for CLN-978, with Phase 1 studies in rheumatoid arthritis and Sjögren's disease set to begin in Q2 2025 [1][6] - The company is advancing its clinical development of CLN-978 across multiple autoimmune diseases and expects to share initial clinical data in systemic lupus erythematosus (SLE) by the end of 2025 [2] - The pivotal Phase 2b study of zipalertinib has met its primary endpoint, with results to be presented at the 2025 ASCO Annual Meeting [3] Immunology - CLN-978 is being developed for systemic lupus erythematosus, rheumatoid arthritis, and Sjögren's disease, with ongoing Phase 1 studies in the U.S., Europe, and Australia [6] - The company plans to initiate a Phase 1 study for active, difficult-to-treat rheumatoid arthritis in Germany and Italy in Q2 2025 [6] - A Phase 1 study for active, moderate to severe Sjögren's disease is also set to begin in the U.S. in Q2 2025 [6] Oncology - The pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib has met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC [3][6] - The company plans to submit a New Drug Application (NDA) for relapsed/refractory EGFR ex20ins NSCLC in the second half of 2025 [6] - Development of CLN-619 in gynecological cancers has been discontinued due to preliminary results not meeting internal advancement thresholds [6] Financial Performance - As of March 31, 2025, the company reported cash and investments totaling $567.4 million, providing a runway into 2028 [3][11] - Research and development expenses for Q1 2025 were $41.5 million, up from $30.6 million in Q1 2024 [11][14] - The net loss attributable to Cullinan for Q1 2025 was $48.5 million, compared to $37.1 million for the same period in 2024 [11][14]