CERo Therapeutics' lead cancer immunotherapy CER-1236 receives FDA Fast Track Designation.

CERo Therapeutics Holdings has received FDA Fast Track Designation for its lead compound, CER-1236, in addition to its existing Orphan Drug Designation for Acute Myeloid Leukemia (AML). This designation creates regulatory and financial advantages for the company's cancer immunotherapy program, highlighting the urgency of the condition and the potential of the compound.

CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting Fast Track Designation to its lead investigational compound, CER-1236, for Acute Myeloid Leukemia (AML). This designation complements the company's existing Orphan Drug Designation, creating additional regulatory and financial advantages for its cancer immunotherapy program.

The Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical needs. It provides CERo with enhanced FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis. Additionally, it requires the company to potentially provide expanded access to the investigational drug on an as-approved basis 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 aims to assess the safety and preliminary efficacy of the compound in patients with AML that is 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: the first part involves dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy.

The 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).

The designation underscores the urgency of the condition and the potential of CER-1236 as a novel approach to cancer immunotherapy. CERo's proprietary T cell engineering platform aims to integrate characteristics of both innate and adaptive immunity into a single therapeutic construct, potentially extending the reach of cellular immunotherapy to both hematologic malignancies and solid tumors.

References:
[1] https://www.stocktitan.net/news/CERO/ce-ro-therapeutics-receives-fda-fast-track-designation-for-cer-1236-2nae07jy0dx5.html
[2] 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