Business
Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
Expanded clinical stage portfolio through licensing of U.S. rights to CLN-418 Received FDA clearance of IND application for CLN-978; submitted IND application
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"Expanded clinical stage portfolio through licensing of U.S. rights to CLN-418 Received FDA clearance of IND application for CLN-978; submitted IND application for CLN-617 Initial clinical data updates for CLN-049 and CLN-619 on track for mid-2023 Potential for 6 clinical stage programs by year end and cash runway into 2026 CAMBRIDGE, Mass., March 09, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; “Cullinan”) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2022. “2022 was a year of remarkable execution at Cullinan Oncology, and the momentum with which we ended the year has continued into early 2023. With our partners at Taiho Oncology, we initiated the pivotal study of zipalertinib in the fourth quarter, while continuing to advance enrollment in the Phase 1 trials of CLN-049 and CLN-619, with initial clinical data expected mid-year,\" said Nadim Ahmed, Chief Executive Officer of Cullinan. “The first two months of 2023 have resulted in similarly exciting developments, as we recently expanded our pipeline through the licensing of U.S. development and commercial rights to CLN-418, a potential first-in-class B7H4x4-1BB bispecific immune activator currently in a Phase 1 study across a variety of solid-tumor indications. This transaction provides us with the opportunity to have six programs in the clinic by the end of the year, as we recently received IND clearance for CLN-978 and also recently filed the IND for CLN-617, consistent with prior guidance. Importantly, our cash position following the CLN-418 transaction provides us with runway into 2026 which gives us the flexibility needed to fund our ongoing development efforts and reach multiple potential value creating milestones.” Portfolio Highlights Zipalertinib: In the fourth quarter of 2022, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., initiated a pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy. As previously planned, the study will enroll patients at the 100mg BID dose under fasted conditions, and also will include a limited cohort of patients to evalua...