CERo Therapeutics Holdings Poised to Initiate Enrollment of Phase 1 Trial of CER-1236 in AML Following Positive FDA Review of Manufacturing

CERo Therapeutics Holdings, Inc. recently announced that the company has received positive review from the US FDA on an amendment to its IND around Chemistry, Manufacturing and Controls (CMC), which marks completion of the Company’s final commitment to FDA prior to initiating patient dosing and shortens the manufacturing timeline by about a week. With this completion, the Company is on track to meet its anticipated timeline of dosing initial subjects during the first half of 2025.

Chris Ehrlich, CERo Therapeutics CEO, added “This is a key completion as we ramp up for initiating our clinical trial of CER-1236. Very often there are additional delays prior to initiating a trial, including manufacturing, chemistry and other follow-on information that FDA may request at the time of or following the clearance of an IND. We have worked diligently to ensure continued progress with the FDA, avoiding additional delays. This is due to our fantastic team and top-notch consultants and partners, including UC Davis, our manufacturing partner, that have been working alongside us on this process. In the meantime, we received acceptance from the American Society of Clinical Oncology (ASCO) of an abstract, which we expect to present at the annual conference in Chicago May 30-June 5. We will provide more updates on that presentation, as well as updating on our program development in the near term.”

The first-in-human, multi-center, open label, Phase 1/ 1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory measurable residual disease positive acute myeloid leukemia. The two-part study will begin with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to further evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK).

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 2025 for hematological malignancies.