CERo Therapeutics, Inc. Announces Publication of Preclinical Research Supporting the Use of Its Clinical Candidate CER-1236 to Treat AML Patients
- Positive results from preclinical studies on CER-1236 targeting AML tumor cells
- High efficacy of CER-1236 in eliminating leukemic cells, with the target present in 83% of patient cells
- Target for CER-1236 detected across various AML genetic subtypes, including adverse risk mutations
- Plans to advance CER-1236 into a Phase I clinical trial for AML and B Cell lymphoma patients
- IND application expected in the first half of 2024
- None.
Insights
The recent findings regarding CERo Therapeutics' lead clinical candidate CER-1236 present significant implications for the treatment of Acute Myelogenous Leukemia (AML). The preclinical studies demonstrating the candidate's ability to target and eliminate leukemic cells in a high percentage of patient-derived samples underscore the potential for a more effective AML therapeutic option. The high expression of the target across various AML subtypes, particularly those with adverse risk mutations, suggests a broad applicability which could address a gap in current treatment regimens.
Moreover, the upcoming Phase I clinical trial and the planned Investigational New Drug (IND) application indicate a strategic move forward in the drug development process. This progression towards clinical application represents a critical step in validating the therapeutic's safety and efficacy in humans. The anticipation of these clinical trials, especially given the preclinical success, may attract investor interest due to the potential market expansion for effective AML treatments.
The announcement by CERo Therapeutics has direct implications for the company's financial outlook and stock market performance. The successful preclinical results and the publication in a reputable journal lend credibility to CER-1236 and may positively influence investor sentiment. The specificity of CER-1236 in targeting AML, coupled with the planned IND filing and subsequent clinical trials, positions CERo to potentially secure a significant share of the AML treatment market.
Investors will likely monitor the progress closely, as movement from preclinical to clinical stages often results in increased capital requirements. Strategic partnerships, funding opportunities and stock price volatility could be expected as the company transitions into these critical phases. It is essential to consider the competitive landscape and the regulatory hurdles that CERo will face, as these factors will play a pivotal role in the company's ability to capitalize on its research and development investments.
From an oncological perspective, the therapeutic targeting of TIM-4-L with engineered T cells as discussed for CER-1236 represents a novel approach in the fight against AML. The high prevalence of the target in leukemic cells, including those with poor prognostic mutations, highlights the potential for a more personalized medicine approach. This could be particularly beneficial for patients who currently have limited treatment options due to the genetic complexity of their disease.
The proposed Phase I clinical trial will be a pivotal moment for the oncology community, as it will provide the first insights into the clinical relevance of these preclinical findings. Safety, dosage and initial efficacy will be scrutinized to assess the potential for CER-1236 to become part of the standard AML treatment protocol. The oncology field is keenly interested in such developments, as they may offer new hope for patients and potentially shift current treatment paradigms.
“This new publication provides support for our plans to test CER-1236 in AML patients in our planned Phase I clinical trial, and moreover extends the scientific data we have produced showing the target for CER-1236 is present on tumor cells from diverse cancers, including ovarian, non-small cell lung cancer (NSCLC), and B cell malignancies,” said Daniel Corey M.D, Ph.D, CERo’s Founder and Chief Technology Officer.
“We’re very pleased with this publication in Clinical Cancer Research supporting our near term plans to advance CER-1236 into the clinic. As we have previously reported, CERo plans to file an Investigational New Drug (IND) application in the first half of 2024, and is targeting initial treatment of AML patients as well as B Cell lymphoma patients before the end of the year,” said Brian G Atwood, CERo’s Chairman and Chief Executive Officer.
About CERo Therapeutics, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ("CER-T"). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ("CAR-T") cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2024 for hematological malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K, as amended, filed on February 27, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Brian Atwood
Chief Executive Officer
batwood@cero.bio
Source: CERo Therapeutics Holdings, Inc.
FAQ
What is the title of the paper published by CERo in Clinical Cancer Research?
What is the target for CER-1236 found in the majority of leukemic cells extracted from patients?
Which genetic subtypes of AML did CER-1236 target show effectiveness in?
When does CERo plan to file an IND application for CER-1236?
What are the near term plans for CER-1236 according to the PR?
