CERo Therapeutics doses third patient in AML clinical trial

SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO), a clinical-stage biotech company with a market capitalization of $6.5 million that InvestingPro analysis suggests is currently undervalued, has dosed the third patient in the starting dose cohort of its Phase 1 clinical trial evaluating CER-1236 in acute myeloid leukemia (AML), the company announced Monday.

This third patient may complete the initial cohort pending safety assessments and dose-limiting toxicity evaluation. The company, which maintains a stronger cash position than debt on its balance sheet, is also anticipating additional results from a second dosing of the second patient in the cohort.

The ongoing first-in-human, multi-center, open-label Phase 1/1b study aims to evaluate the safety, tolerability, and preliminary activity of CER-1236 in patients with various forms of AML, including relapsed/refractory cases and newly diagnosed patients with specific mutations.

"Advancing to the third and final planned patient at the starting dose level represents an important step in this first-in-human evaluation of CER-1236," said Stephen Strickland, Jr., Director of Leukemia Research at Sarah Cannon Research Institute and lead investigator at the dosing site.

According to the company’s statement, pharmacokinetic data has shown cell expansion at this lowest dose level. The protocol has been modified with IRB approval to allow for a second infusion in the same subject, potentially increasing dosing potential within each cohort.

CER-1236 utilizes CERo’s proprietary approach to T cell engineering, which the company calls Chimeric Engulfment Receptor T cells (CER-T). This technology integrates characteristics of both innate and adaptive immunity by building in phagocytic mechanisms to destroy cancer cells.

The trial will progress from dose escalation to establish a recommended Phase 2 dose, followed by an expansion phase to further characterize safety and exploratory efficacy, according to the press release. While the stock has faced significant pressure, declining over 95% year-to-date, InvestingPro subscribers can access 10+ additional investment insights and detailed financial metrics to better evaluate the company’s potential. Discover more exclusive analysis and investment tools at InvestingPro.

In other recent news, CERo Therapeutics Holdings, Inc. has made several significant advancements related to its lead investigational compound, CER-1236. The company received a Notice of Allowance from the U.S. Patent and Trademark Office for patent protection of CER-1236, which will extend its composition of matter protection through 2041. Additionally, CERo secured a similar patent in Japan for its CER platform technology. The U.S. Food and Drug Administration granted Fast Track Designation to CER-1236, which aims to expedite the development and review process for therapies targeting serious conditions with unmet medical needs.

In clinical trial developments, CERo has administered a second dose to the second patient in the first cohort of its Phase 1 trial for acute myeloid leukemia (AML), following approval from the study’s Institutional Review Board. This multi-dose intensification will double the amount of cell product infused compared to the previous protocol. The trial is being conducted at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute, with Dr. Yazan Migdady as the principal investigator. Monitoring for safety, tolerability, and efficacy continues as the company reports promising initial pharmacokinetic data showing cell expansion.

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