Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia

Cullinan Therapeutics reported Phase 1 results for CLN-049 in relapsed or refractory AML or MDS, showing a 45% response rate and 21% CRc rate at the 12 µg/kg dose. Updated data will be presented at ASH. The company plans to explore selected dose regimens in an ongoing Phase 2 trial.

Cullinan Therapeutics (CGEM) will present data on its T cell engager programs at the ASH meeting, including updated Phase 1 data for CLN-049 in relapsed/refractory AML, showing anti-leukemic activity and a safety profile. The company also has trials in progress for CLN-049 combinations and velinotamig in autoimmune diseases. CLN-049 has FDA Orphan Drug and Fast Track designations.

Taiho Oncology and Cullinan Therapeutics (CGEM) reported Phase 2 trial results for zipalertinib in lung cancer patients with brain metastases. The drug showed a 30.2% intracranial response rate and was well tolerated. Data will be presented at the ESMO Congress 2026. CGEM is developing the investigational drug.

Taiho Oncology and Cullinan Therapeutics (CGEM) reported that zipalertinib, an experimental lung cancer drug, showed clinically meaningful intracranial antitumor activity in a Phase 2b trial. Among 43 patients, it achieved a 67.4% intracranial objective response rate. The drug is being evaluated for NSCLC with EGFR mutations and active CNS metastases. Results will be presented at ESMO Congress 2026.

Cullinan Therapeutics (CGEM) dosed the first patient in a Phase 2 study of CLN-049 for relapsed/refractory AML. The study aims to evaluate the treatment's efficacy in patients with limited options. CLN-049 has Orphan Drug and Fast Track designations from the FDA. CGEM's stock is down 2.62% to $15.22.

Cullinan Therapeutics began submitting an NDA for zipalertinib with chemotherapy to treat certain lung cancer patients, backed by Phase 3 trial data. The FDA has given the drug Breakthrough Therapy designation. A separate NDA for zipalertinib alone is under review with a decision expected by February 27, 2027, according to the company.