Cullinan Therapeutics to present Phase 1 CLN‑049 data at ASH meeting
Cullinan Therapeutics announced that it will showcase updated Phase 1 results for its FLT3xCD3 T‑cell engager CLN‑049 at the 68th American Society of Hematology meeting in New Orleans (Dec 12‑15). The data include anti‑leukemic activity at 6 µg/kg and 12 µg/kg doses and a safety profile for a double step‑up regimen. The company also disclosed a 45% overall response rate and a 21% composite complete remission rate at the 12 µg/kg dose. CLN‑049 holds U.S. FDA Orphan Drug and Fast Track designations.
Why it matters
The reported response and safety signals could lift investor expectations for Cullinan’s upcoming Phase 2 trial and affect the CGEM share price. The FDA designations may accelerate regulatory review, potentially shortening the path to market.
Key facts
- 1Cullinan will present four poster presentations at the 68th ASH Annual Meeting, scheduled for Dec 12‑15 in New Orleans. investing.com
- 2The CLN‑049 Phase 1 dose escalation study enrolled patients with relapsed or refractory AML or MDS. investing.com
- 3Selected Phase 2 target doses are 6 µg/kg and 12 µg/kg, using a double step‑up dosing regimen. investing.com
- 4Phase 1 data showed a 45% response rate at the 12 µg/kg dose. tradingview.com
- 5Phase 1 data showed a 21% composite complete remission (CRc) rate at the 12 µg/kg dose. tradingview.com
- 6CLN‑049 has received Orphan Drug and Fast Track designations from the U.S. FDA for relapsed or refractory AML. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.