CERo Therapeutics receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia treatment

CERo Therapeutics' lead compound, CER-1236, has been granted Fast Track Designation by the FDA for Acute Myeloid Leukemia. This designation, in addition to existing Orphan Drug Designation, aims to expedite the development and approval process for the compound. A Phase 1/1b study is underway to evaluate the safety and efficacy of CER-1236 in patients with relapsed/refractory or newly diagnosed acute myeloid leukemia.

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 — CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead investigational compound, CER-1236, for the treatment of Acute Myeloid Leukemia (AML). This designation, in addition to the existing Orphan Drug Designation, aims to expedite the development and approval process for the compound.

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

CER-1236 is currently being evaluated in a first-in-human, multi-center, open label, Phase 1/1b study. This study is designed to assess the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory or newly diagnosed AML. The two-part study has begun with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy.

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).

CERo Therapeutics is an innovative immunotherapy company advancing the development of next-generation engineered T cell therapeutics for cancer treatment. Its proprietary approach to T cell engineering integrates desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, aiming to engage the body’s full immune repertoire for optimized cancer therapy. The company believes that its differentiated activity of CER-T cells may offer advantages compared to currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors.

The Fast Track Designation is an important milestone for CERo Therapeutics, validating the urgency of the condition and the potential of CER-1236. It is expected to decrease the potential time to market and provide additional benefits across the FDA process, proving both medically and financially valuable.

References:
[1] https://www.nasdaq.com/press-release/cero-therapeutics-receives-fda-fast-track-designation-cer-1236-acute-myeloid-leukemia
[2] https://www.stocktitan.net/news/CERO/ce-ro-therapeutics-receives-fda-fast-track-designation-for-cer-1236-2nae07jy0dx5.html