CERo Therapeutics, Inc. Presents CER-1236 Data Supporting Use in AML at Global Cell & Gene Therapy Summit 2024
CERo Therapeutics (Nasdaq: CERO) presented data on their lead compound, CER-1236, at the Global Cell & Gene Therapy Summit 2024. The data reveals that TIM-4-L, a target for engineered T cell therapy, is prevalent in acute myeloid leukemia (AML) but absent in healthy tissue. CER-1236 demonstrated strong cytotoxicity against TP53 mutant AML in both in vitro and in vivo studies without causing adverse effects in healthy tissues, even at high doses. The company anticipates the start of initial human trials focused on AML pending IND clearance.
- CER-1236 showed potent cytotoxicity against TP53 mutant AML in studies.
- No adverse toxicities were observed in healthy tissues, indicating safety.
- Completion of IND-enabling work and anticipation of initial human trials.
- None.
Insights
CER-1236 targeting TIM-4-L in AML is an exciting development in the fight against acute myeloid leukemia, especially considering the lack of effective treatments for TP53 mutant variants. The finding that TIM-4-L is prevalent in AML but not in healthy tissues provides a clear target for the engineered T cell therapy. This suggests the potential for high specificity and reduced off-target effects, which are common concerns in cancer therapies.
Engraftment in lymphoid tissues without noted adverse effects in preclinical studies points to a favorable safety profile, a important consideration before human trials. However, while these results are promising, they are still in the early stages. Actual clinical efficacy and safety in humans remain to be seen once IND clearance is obtained.
For retail investors, understanding the potential impact of such a therapy is important. If successful, it could lead to a significant advancement in AML treatment and potentially other cancers with similar markers. Short-term, there may be volatility as the company moves towards clinical trials. Long-term success hinges on the outcomes of these trials.
The preclinical data for CER-1236 presented at the Cell & Gene Therapy Summit shows promising early results. The study highlights both in vitro and in vivo cytotoxicity against TP53 mutant AML, which is notorious for being difficult to treat. This compound demonstrating efficacy in such models is significant, but investors should be aware that preclinical results do not always translate directly to clinical success.
The absence of adverse toxicities in high-dose studies is also notable, underscoring the potential safety of the therapy. This could streamline its path through regulatory scrutiny, assuming the data holds up in human trials. This step is critical as it often dictates the speed and feasibility of bringing a new therapy to market.
Investors should watch for updates on the IND clearance and subsequent human trials, as these milestones will provide more substantial data on the compound's viability. The announcement underscores a pivotal moment for CERo, as successful trials could position the company prominently within the immunotherapy landscape.
Company anticipates initial human trials to focus on AML upon IND clearance
SOUTH SAN FRANCISCO, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo”), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces presentation of a poster on its lead compound CER-1236 at the Global Cell & Gene Therapy Summit 2024. The conference is being held July 8-10 in Boston.
The poster, titled, “Aberrant Expression of TIM-4-L is a Common Feature of AML and Potential Target for Engineered T Cell Therapy” presents data showing that TIM-4-L is prevalent on multiple acute myeloid leukemia (AML) subsets, but not present in healthy tissue. The study continues that CER-1236, CERo’s lead compound, showed potent in vitro and in vivo cytotoxicity against TP53 mutant AML. Further, a full-scale toxicity study revealed that CER-1236 T cells engraft in lymphoid tissues, but do not cause any in-life observations, clinical pathology, or histopathological evaluations. This indicates that CER-1236 is not associated with any adverse toxicities against healthy tissue, even at high doses. The poster, which is being presented on July 8, 2024, can be accessed here.
CERo Chairman and CEO Brian G. Atwood comments, “This poster is validation of our recent announcement regarding the completion of toxicity evaluations for CER-1236. The prevalence of TIM-4-L in AML as compared to healthy tissue is important, as it makes it a viable target that may have an impact on the disease. CER-1236 action in AML compared to in healthy tissue also shows promise for the compound. Cell & Gene Therapy is an important conference, and the acknowledgement of these data will be instrumental in further discussion with the scientific community in explaining the potential we see for our compound.
“In the meantime, with all IND-enabling work complete, we are in close communication with the U.S. Food and Drug Administration as we prepare for the possibility of entering the clinic with CER-1236 for AML in the short term,” concluded Mr. Atwood.
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 Annual Report on Form 10-K, filed on April 2, 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.
Contact:
Brian Atwood
Chief Executive Officer
batwood@cero.bio
Investors:
CORE IR
investors@cero.bio
FAQ
What did CERo Therapeutics present at the Global Cell & Gene Therapy Summit 2024?
What is the significance of TIM-4-L in CER-1236's research?
Did CER-1236 show any adverse effects in studies?
When does CERo Therapeutics anticipate starting human trials for CER-1236?
