TIMD4

SOUTH SAN FRANCISCO, Calif., April 30, 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 and innate immune system mechanisms, announces it is presenting preclinical data on its lead product candidate CER-1236 at the Stanford Drug Discovery Symposium, which is being held April 29-30, 2024 in Palo Alto, Calif. The poster, titled, “TIM-4-L-targeting CER-1236 Engineered T cells Eliminate Adverse-Risk AML Xenografts and Exhibit Favorable Manufacturing Product Attributes for Clinical Translation,” outlines key attributes of the program. Specifically, the data highlights the capabilities of CER-1236 engineered T cells in eliminating adverse-risk p53mutated AML cell lines in vivo and low risk of off-tumor toxicity to hematopoietic progenitor stem cells (HSPCs). The poster also highlights manufacturing data demonstrating the Company’s capacity to generate high yields of CER-1236 drug product exhibiting naïve and central memory phenotypes, which enhance the activity of the therapy. Details of the poster can be found here. CERo Founder and CTO Daniel Corey comments, “CER-1236 engineered T cells targeting TIM-4-L are a novel and differentiated therapeutic approach for leukemia with encouraging pre-clinical data. We have demonstrated the capacity to manufacture high yields of CER-1236 with favorable memory and immunophenotypic pro We are diligently working on an IND submission in the near term. We look forward to continuing to provide appropriate updates to shareholders as they develop.” 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. Contact: Brian Atwood Chief Executive Officer batwood@cero.bio Investors: CORE IR investors@cero.bio

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- 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 today announced the publication in Clinical Cancer Research, a journal of the American Association for Cancer Research, a paper titled “Therapeutic Targeting of TIM-4-L With Engineered T Cells for Acute Myeloid Leukemia.” The paper details preclinical studies by CERo analyzing its lead clinical candidate CER-1236 in targeting Acute Myelogenous Leukemia (AML) tumor cells from human patients, and the candidate’s killing effects on these tumor cells. The results in the paper found that the target for CER-1236 is found in the large majority (83%) of leukemic cells extracted from the bone marrow from patients, and that more importantly CER-1236 effectively eliminated leukemic cells in the company’s experiments. Finally, the target for CER-1236 was found by CERo to be highly expressed and detectable across common AML genetic classification subtypes, including patient samples with adverse risk mutations in TP53, ASXL1 and RUNX1. “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 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.

BOSTON, May 17, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the U.S. Patent & Trademark Office issued its U.S. Patent No. 11,648,225, entitled “Compositions And Methods For Reducing Immune Intolerance And Treating Autoimmune Disorders.” The patent is directed to LPX-TI641, LAPIX’s novel, first-in-class, immune tolerance restoration small molecule. LPX-TI641 has been purposefully designed to be a Tim3 and Tim4 agonist that can restore the regulatory T cell (Treg) population in an antigen-agnostic manner for treating autoimmune diseases. LPX-TI641 is currently under development for neuro-autoimmune indications such as multiple sclerosis (MS) with the intent of expanding to other indications and is expected to begin Phase I enrollment in July 2023. “Treating autoimmune diseases by re-establishing self-tolerance, in an antigen agnostic manner, with an orally administered therapeutic is a new approach that will unleash the power of immune tolerance while breaking free of the limitations of yesteryear’s antigen-specific immune tolerance approaches,” said Anas M. Fathallah, Ph.D., CEO and Co-founder of LAPIX. “This is very promising for the treatment of autoimmune diseases in general and MS in particular. The issuance of this patent marks a significant step towards creating a new patient-centric standard of care that restores the immune system to its natural state without the immune system wrecking ball approach of many other autoimmune treatments.” MS and other autoimmune diseases are characterized by loss of tolerance towards self and are often associated with the downregulation of functional regulatory T and B-cells (Treg and Breg) and upregulation of autoreactive pathogenic T helper type 17 and type 1 T cells (Th). This new treatment approach allows the adaptive immune system to re-establish self-tolerance by restoring the Treg/pathogenic T-cell imbalance associated with autoimmune diseases, without affecting the innate immune system and without inducing leukopenia or lymphocytopenia (a side effect of many autoimmune treatments). Substantial preclinical data demonstrated the superiority of LPX-TI641 as monotherapy versus standards of care in both treatment escalation and treatment induction/maintenance paradigms currently in use for the clinical management of MS. Pre-clinical efficacy and safety data support positioning LPX-TI641 as a high potency molecule that is effective enough to control aggressive disease and safe for long-term use. About LAPIX Therapeutics LAPIX Therapeutics Inc. is a Boston, MA-based company in the biopharma sector, focused on developing novel, orally bioavailable immune system restoration therapies, including immune tolerance restoration therapy for autoimmune diseases, immune tolerance induction therapies for gene therapy and enzyme replacement therapy, and immune function restoration therapies for oncology. To learn more, visit www.lapix.com or follow us on LinkedIn and Twitter. Contact:Anas M. Fathallah, Ph.D.CEO and Co-Founderinfo@lapixtherapeutics.com