CERo Therapeutics Receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia (AML): Enhancing Regulatory and Financial Advantages for Lead Cancer Immunotherapy Program.

CERo Therapeutics has received FDA Fast Track Designation for its lead investigational compound, CER-1236, in Acute Myeloid Leukemia (AML). This designation adds to the existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company's cancer immunotherapy program. The FDA designation is designed to accelerate development and review of therapies for serious conditions with unmet medical need. CERo's Phase 1/1b study is currently underway to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML.

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 — CERo Therapeutics Holdings, Inc. (Nasdaq: CERO), an innovative cellular immunotherapy company, has received a significant regulatory milestone from the U.S. Food and Drug Administration (FDA). The FDA has granted Fast Track Designation to the Company’s lead investigational compound, CER-1236, for the treatment of Acute Myeloid Leukemia (AML). This designation complements the existing Orphan Drug Designation, creating additional regulatory and financial advantages for CERo’s cancer immunotherapy program [1].

The Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical need. This designation provides CERo with increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis. Additionally, it allows for expanded access to the investigational drug under pre-specified conditions [1].

The first-in-human, multi-center, open label, Phase 1/1b study for CER-1236 is currently underway. The study aims to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML who are either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed with TP53 mutated MDS/AML or AML. The study is divided into two parts: a dose escalation phase to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy [1].

Primary outcome measures include the 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) [1].

CERo’s proprietary approach to T cell engineering integrates desirable characteristics of both innate and adaptive immunity into a single therapeutic construct. This innovative platform is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. The Company believes that this novel cellular immunotherapy platform, known as Chimeric Engulfment Receptor T cells (CER-T), may offer advantages compared to currently approved CAR-T therapies and could extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors [1].

The Fast Track Designation is expected to decrease the potential time to market and provide additional benefits across the FDA process, proving both medically and financially valuable. CERo is currently conducting clinical trials for its lead product candidate, CER-1236, for hematological malignancies [1].

References:
[1] https://www.globenewswire.com/news-release/2025/09/05/3145236/0/en/CERo-Therapeutics-Receives-FDA-Fast-Track-Designation-for-CER-1236-in-Acute-Myeloid-Leukemia-AML.html