Carina Biotech Receives FDA Safe to Proceed Letter for IND Application for Phase 1/2a Clinical Trial of

• Receives greenlight from the FDA for Phase 1/2a clinical trial of CNA3103
• On track to commence patient enrollment during the first half 2023

ADELAIDE, Australia , Jan. 23, 2023 (GLOBE NEWSWIRE) -- Carina Biotech Pty Ltd ("Carina," "the Company"), a cell therapy immuno-oncology company developing CAR-T and other adoptive cell therapies for the treatment of solid cancers, announced today that it has received the "safe to proceed" letter from the U.S. FDA for its Investigational New Drug (NDA) application to conduct a first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer (CRC).

The Phase 1/2a clinical trial will enroll a total of 44 patients with metastatic disease failing prior lines of chemotherapy and who express LGR5 on their cancer cells. Twenty-four patients in the Phase 1 segment will be enrolled in select Australian centers. Following a BOIN (Bayesian Optimal Interval) design, ascending CAR-T cell doses will be administered to cohorts of three patients each, to assess the safety and tolerability of CNA3103, and to determine its optimal dose. The subsequent Phase 2 segment will enroll 20 patients at the optimal dose, in both Australia and the U.S., to characterize the activity of CNA3103, in terms of antitumor response, duration of response and time to disease progression.