CERo Therapeutics begins phase 1 trial for leukemia treatment

SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO) announced the initiation of a Phase 1 clinical trial for its lead product candidate, CER-1236, with the first patient now undergoing treatment. The trial, which focuses on acute myeloid leukemia (AML), has commenced dose escalation to identify the maximum tolerated dose for future study phases. According to InvestingPro data, while CERo maintains a stronger cash position than debt, the company’s overall financial health score indicates challenges ahead. The company’s market capitalization currently stands at $2.78 million.

The trial’s lead investigator, Dr. Abhishek Maiti from The University of Texas MD Anderson Cancer Center, has collaborated with CERo on publishing preclinical data. The open-label study will evaluate safety and preliminary efficacy in patients with AML, including those with relapsed or refractory AML, or newly diagnosed cases with specific genetic mutations.

Primary outcome measures of the trial include the incidence of adverse events and the overall response rate, with secondary measures assessing the pharmacokinetics of CER-1236. The study will also explore the efficacy of the treatment in achieving complete response and measuring residual disease.

CERo’s Chief Medical Officer, Dr. Robert Sikorski, expressed that reaching the first-in-human dosing stage marks a significant milestone for the novel autologous CAR-T therapeutic candidate, which targets TIM-4L. The company will present details of the Phase 1/1b study at the American Society of Clinical Oncology 2025 Annual Meeting in Chicago.

CEO Chris Ehrlich conveyed gratitude for the progress made and the contributions of the first patient and the teams involved. He anticipates additional outcomes to support the scientific research behind CER-1236. The company’s stock has faced significant headwinds, with InvestingPro analysis showing a 97% decline over the past six months. Analysts maintain coverage with price targets ranging from $3 to $11 per share, suggesting potential upside from current levels.

CERo Therapeutics is an immunotherapy company focused on developing engineered T cell therapeutics. Its CER-T platform aims to integrate aspects of both innate and adaptive immunity to combat cancer more effectively, potentially extending applications beyond hematological malignancies to solid tumors. Based on InvestingPro’s Fair Value analysis, the stock appears undervalued at current levels. Subscribers can access 10+ additional ProTips and comprehensive financial metrics to better evaluate the company’s potential.

This press release statement includes forward-looking statements regarding CERo’s business strategy and plans, which involve risks and uncertainties that could cause actual results to differ materially from projected outcomes. These risks are detailed in the company’s SEC filings.

In other recent news, CERo Therapeutics has announced the initiation of a Phase 1 clinical trial for its novel therapy, CER-1236, targeting acute myeloid leukemia (AML). The trial, conducted in collaboration with Sarah Cannon Research Institute, aims to evaluate the safety and preliminary efficacy of the treatment. Enrollment is underway, with the first patient dosing expected in the first half of 2025. This development follows CERo Therapeutics regaining compliance with Nasdaq’s minimum stockholders’ equity requirement, achieved through financial maneuvers, including a private placement and a public offering. Additionally, Maxim Group has initiated coverage on CERo Therapeutics with a Buy rating and a price target of $3.00, highlighting the potential of CER-1236’s innovative technology. The company has also secured $8 million in funding to support its T cell therapeutic programs, with plans to expand clinical trial sites, including a new site at MD Anderson Cancer Center. These developments underscore CERo’s focus on advancing its lead program and exploring broader applications for its Chimeric Engulfment Receptor T cells (CER-T) technology.

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