CERo Therapeutics begins Phase 1 trial for AML treatment

Published 24/04/2025, 13:26
CERo Therapeutics begins Phase 1 trial for AML treatment

SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO), a micro-cap biotech company with a market capitalization of $4.3 million specializing in engineered T cell immunotherapies, has announced the initiation of a Phase 1 clinical trial for its product CER-1236, targeting acute myeloid leukemia (AML) patients. According to InvestingPro data, the company maintains a stronger cash position relative to its debt, though it remains unprofitable over the last twelve months. The trial is being conducted in collaboration with Sarah Cannon Research Institute at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

Patient enrollment for the study is currently underway, with the first dosing of the initial cohort expected by June. The trial aims to assess the safety and preliminary efficacy of CER-1236 in AML patients who have relapsed, are refractory, have measurable residual disease, or carry a TP53 gene mutation.

Dr. Yazan Migdady of CBCI, an investigator in the trial, expressed optimism about the potential of CER-1236 to improve clinical outcomes and survival rates for AML patients through its novel chimeric engulfment receptor technology.

The first-in-human, multi-center trial will consist of two parts, starting with a dose escalation phase to establish the highest tolerated dose and the recommended dose for Phase 2. This will be followed by an expansion phase to further evaluate safety and efficacy. The trial announcement comes as CERo’s stock has experienced significant volatility, with InvestingPro showing a notable 30% return over the past week, despite a challenging six-month period where shares declined by 90%. Key measures of the trial include tracking adverse events, dose-limited toxicities, and estimating overall response rates and complete responses.

CERo’s CEO, Chris Ehrlich, highlighted CBCI’s reputation as a leading cancer center and expressed confidence that their involvement in the AML trial reaffirms the scientific progress made with CER-1236. Ehrlich also mentioned an upcoming trial for solid tumors.

CERo Therapeutics’ approach to T cell engineering aims to combine aspects of innate and adaptive immunity to create Chimeric Engulfment Receptor T cells (CER-T), which may have wider applications in treating both hematological malignancies and solid tumors compared to current CAR-T cell therapies.

This news is based on a press release statement, and while it contains forward-looking statements regarding CERo’s plans and the potential of its product candidate, these are not guarantees of future performance and are subject to risks outlined in the company’s SEC filings. InvestingPro analysis reveals the company’s overall financial health score as "WEAK," with particularly challenging metrics in profitability. Investors seeking deeper insights into CERo’s financial position and additional ProTips can access comprehensive analysis through an InvestingPro subscription.

In other recent news, CERo Therapeutics Holdings, Inc. has announced several key developments. The company secured $8 million in funding through a convertible preferred stock transaction to advance its T cell therapeutic programs, particularly targeting liquid and solid tumor indications. This capital will support the launch of new clinical trial sites, including one at MD Anderson Cancer Center, and help the company meet Nasdaq’s Shareholders Equity requirements. In addition, CERo received FDA approval to proceed with a Phase 1 clinical trial for its lead compound, CER-1236, aimed at treating advanced solid tumors such as non-small cell lung cancer and ovarian cancer. The FDA’s green light comes as CERo also initiates a separate trial for acute myeloid leukemia. Furthermore, CERo expanded its patent portfolio with two significant allowances from the U.S. Patent and Trademark Office, enhancing its intellectual property rights for CER-1236. Boral Capital initiated coverage on CERo with a Buy rating and an $11.00 price target, citing the company’s innovative T cell engineering platform as a differentiator in the cell therapy market. These recent developments underscore CERo’s ongoing efforts to advance its proprietary cancer immunotherapy technologies.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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