CERo Therapeutics Holdings, Inc. reported that the dose‑limiting toxicity (DLT) observation period for Cohort 1 of its Phase 1/1b trial of CER‑1236 in acute myeloid leukemia (AML) has been completed. The first patient in Cohort 1 reached the 14‑day DLT endpoint with no dose‑limiting toxicities observed.
The company also administered a 4‑million‑cells‑per‑kilogram dose of CER‑1236 to the first patient in Cohort 2, a four‑fold increase over the 1‑million‑cells‑per‑kilogram dose used in Cohort 1. That patient likewise completed the DLT observation period without adverse events, and a fourth dose was given to the second patient in Cohort 1, who remains on study.
"Enrollment and dosing are ongoing in our Phase 1 clinical trial of CER‑1236. The first patient in the second cohort has received a higher cell dose, and safety monitoring is continuing. In addition, one patient in the first cohort has received an additional dose and remains on study," said CEO Chris Ehrlich. "We are focused on the careful conduct of the dose‑escalation phase and the systematic collection of safety data as the trial proceeds."
CERo is a pre‑revenue biotechnology company that has yet to generate sales and reports significant operating losses. Its balance sheet shows a current ratio of 0.3 and a quick ratio of 0.3, underscoring liquidity constraints. The company’s strategy centers on next‑generation engineered T‑cell therapeutics that combine innate and adaptive immune features, with CER‑1236 targeting the TIM‑4 ligand in AML.
The trial is a first‑in‑human, multi‑center, open‑label study designed to identify the highest tolerated dose and the recommended phase 2 dose. Successful completion of the DLT observation for Cohort 1 and the safe administration of the higher dose in Cohort 2 are key steps toward expanding the safety and efficacy data set and moving the program into the expansion phase.
While the company’s stock trades on the OTCQB market and no immediate market‑reaction data are available, the clinical progress represents a positive development for CERo’s pipeline and may support future funding rounds or partnership opportunities as the company continues to demonstrate safety and potential efficacy in a disease with high unmet need.
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