Business
Cullinan Oncology Provides Corporate Update and Reports First Quarter 2023 Financial Results
Zipalertinib pivotal trial now enrolling at the 100mg BID dose only First clinical data for CLN-049 and CLN-619 to be reported at EHA 2023 Congress and ASCO
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":" Zipalertinib pivotal trial now enrolling at the 100mg BID dose only First clinical data for CLN-049 and CLN-619 to be reported at EHA 2023 Congress and ASCO 2023 Annual Meeting, respectively Cash and investment position of $503.5 million as of March 31, 2023 continues to give runway into 2026 CAMBRIDGE, Mass., May 11, 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 first quarter ended March 31, 2023. “We made important progress in the first quarter of this year and believe that 2023 will be a transformational year for Cullinan Oncology,” said Nadim Ahmed, Chief Executive Officer of Cullinan. “Consistent with our guidance on reporting first clinical data from two of our ongoing Phase 1 studies by mid-year, preliminary safety data for CLN-049 were published in abstract form today as part of the 2023 EHA Congress and first clinical data for CLN-619 will be presented during a poster session at the upcoming ASCO Annual Meeting. Additionally, enrollment in the zipalertinib pivotal study will now continue at the 100mg BID dose only. We also continue to progress our diverse pipeline: both CLN-978 and CLN-617 received FDA clearance of IND applications in the first quarter, which will allow us to initiate first-in-human studies this year. Finally, 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. Together, these achievements position us well with six programs in the clinic this year as we work toward our mission of creating new standards of care for patients with cancer.” Portfolio Highlights Zipalertinib: Enrollment will continue solely at the 100 mg BID dose level in the pivotal study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer patients progressing after prior systemic therapy. Further enrollment in the 150mg BID cohort was recently discontinued based upon recommendation of the safety review committee. CLN-049: CLN-049 is a FLT3xCD3 T cell-engaging bispecific antibody being investigated in p...