Cullinan Therapeutics

Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting

a month ago

• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types. • Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US. • The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.

Zipalertinib Shows Promise in NSCLC with EGFR Exon 20 Insertion Mutations

4 months ago

• Zipalertinib achieved the primary endpoint of overall response rate (ORR) in the REZILIENT1 trial for NSCLC patients with EGFR exon 20 insertion mutations. • Patients pretreated with amivantamab only showed a 50% ORR, while those with prior amivantamab and other exon 20-directed agents had a 25% ORR. • The safety profile of zipalertinib was consistent with prior findings, with manageable treatment-related adverse events. • Regulatory submission for zipalertinib in the U.S. is planned for the second half of 2025, pending FDA discussions.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Cullinan Therapeutics Advances CLN-978 for SLE Treatment with Phase 1 Trial Approval

8 months ago

• Cullinan Therapeutics has received approval to initiate a global Phase 1 clinical trial of CLN-978 for systemic lupus erythematosus (SLE). • The Phase 1 trial will assess the safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients across multiple sites, including Australia. • CLN-978 is a novel CD19xCD3 bispecific T cell engager designed for convenient dosing and potential treatment-free remission in SLE patients. • The FDA has also approved Cullinan to expand its global trial to include U.S. patients with moderate to severe SLE.