CERo Therapeutics Receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia (AML)
CERo Therapeutics (NASDAQ:CERO) has received Fast Track Designation from the FDA for its lead compound CER-1236 in treating Acute Myeloid Leukemia (AML). This designation, complementing its existing Orphan Drug Designation, aims to accelerate development and review of the therapy.
The company is currently conducting a Phase 1/1b first-in-human study evaluating CER-1236's safety and preliminary efficacy in multiple AML patient groups. The trial includes dose escalation to determine optimal dosing, followed by an expansion phase focusing on safety and efficacy measures including response rates and pharmacokinetics.
CERo Therapeutics (NASDAQ:CERO) ha ottenuto la Designazione Fast Track dalla FDA per il suo composto di punta CER-1236 nel trattamento della leucemia mieloide acuta (AML). Questa designazione, che si affianca alla gi脿 acquisita Designazione di Farmaco Orfano, mira ad accelerare lo sviluppo e la revisione del trattamento.
L'azienda sta conducendo uno studio di Fase 1/1b first-in-human per valutare la sicurezza e l'efficacia preliminare di CER-1236 in diversi gruppi di pazienti con AML. Lo studio prevede una fase di escalation delle dosi per individuare il dosaggio ottimale, seguita da una fase di espansione focalizzata su sicurezza ed efficacia, incluse le percentuali di risposta e la farmacocinetica.
CERo Therapeutics (NASDAQ:CERO) ha recibido la Designaci贸n Fast Track de la FDA para su compuesto principal CER-1236 en el tratamiento de la leucemia mieloide aguda (LMA). Esta designaci贸n, que complementa su actual Designaci贸n de Medicamento Hu茅rfano, busca acelerar el desarrollo y la revisi贸n de la terapia.
La compa帽铆a est谩 llevando a cabo un estudio Fase 1/1b first-in-human para evaluar la seguridad y la eficacia preliminar de CER-1236 en varios grupos de pacientes con LMA. El ensayo incluye una escalada de dosis para determinar la dosis 贸ptima, seguida de una fase de expansi贸n centrada en medidas de seguridad y eficacia, como las tasas de respuesta y la farmacocin茅tica.
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CERo Therapeutics (NASDAQ:CERO) a re莽u la d茅signation Fast Track de la FDA pour son compos茅 principal CER-1236 dans le traitement de la leuc茅mie my茅lo茂de aigu毛 (LMA). Cette d茅signation, en compl茅ment de sa d茅signation de m茅dicament orphelin, vise 脿 acc茅l茅rer le d茅veloppement et l'examen de la th茅rapie.
La soci茅t茅 m猫ne actuellement une 茅tude de Phase 1/1b first-in-human 茅valuant la s茅curit茅 et l'efficacit茅 pr茅liminaire de CER-1236 chez plusieurs groupes de patients atteints de LMA. L'essai comprend une escalade de dose pour d茅terminer la posologie optimale, suivie d'une phase d'expansion ax茅e sur les crit猫res de s茅curit茅 et d'efficacit茅, notamment les taux de r茅ponse et la pharmacocin茅tique.
CERo Therapeutics (NASDAQ:CERO) hat f眉r seinen f眉hrenden Wirkstoff CER-1236 bei der Behandlung der akuten myeloischen Leuk盲mie (AML) die Fast-Track-Zulassung durch die FDA erhalten. Diese Zulassung erg盲nzt die bereits bestehende Orphan-Drug-Designation und soll die Entwicklung und Pr眉fung der Therapie beschleunigen.
Das Unternehmen f眉hrt derzeit eine Phase-1/1b First-in-Human-Studie durch, in der die Sicherheit und die vorl盲ufige Wirksamkeit von CER-1236 in mehreren AML-Patientengruppen untersucht werden. Die Studie umfasst eine Dosis-Eskalationsphase zur Bestimmung der optimalen Dosierung, gefolgt von einer Expansionsphase, die sich auf Sicherheits- und Wirksamkeitsparameter wie Ansprechquoten und Pharmakokinetik konzentriert.
- Received FDA Fast Track Designation for CER-1236, accelerating development and review process
- Already holds Orphan Drug Designation, providing additional regulatory and financial benefits
- Potential eligibility for priority review and rolling submission of data
- Phase 1/1b clinical trial already underway with multiple patient cohorts
- Early-stage clinical development (Phase 1/1b) with no efficacy data yet
- May need to provide expanded access to investigational drug, potentially increasing costs
Insights
FDA Fast Track Designation for CER-1236 significantly accelerates development timeline, enhances CERo's regulatory advantages, and validates therapeutic potential in AML treatment.
The FDA Fast Track Designation granted to CERo Therapeutics' lead compound CER-1236 represents a significant regulatory milestone with tangible development advantages. When combined with its existing Orphan Drug Designation, CERo now enjoys a comprehensive suite of regulatory benefits that could meaningfully compress the development timeline for this novel AML therapy.
The designation specifically provides CERo with three critical advantages: increased FDA interactions, potential priority review eligibility, and the ability to submit clinical data on a rolling basis. These benefits directly address the high-risk bottlenecks in the regulatory pathway that frequently delay promising oncology therapies.
For context, Fast Track status is reserved for therapies targeting serious conditions with substantial unmet need - a recognition of both AML's severity (
The ongoing Phase 1/1b trial structure is strategically designed with dual efficacy/safety endpoints and includes multiple patient populations: relapsed/refractory AML, patients in remission with measurable residual disease, and newly diagnosed patients with specific genetic mutations. This comprehensive approach maximizes the potential regulatory pathways and could support accelerated approval based on surrogate endpoints like measurable residual disease clearance.
The mechanism involving "phagocytic mechanisms" suggests CER-1236 employs a novel approach distinct from conventional CAR-T therapies, potentially addressing resistance mechanisms common in AML treatment failures. The FDA's recognition through these dual designations validates the scientific rationale and preliminary data supporting this innovative immunotherapeutic approach.
Regulatory milestone adds to its existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company鈥檚 lead cancer immunotherapy program
SOUTH SAN FRANSCISCO, Calif., Sept. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (鈥淐ERo鈥� or the 鈥淐ompany鈥�) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Company鈥檚 lead investigational compound, CER-1236 for Acute Myeloid Leukemia (AML). This designation is in addition to the existing .
鈥淭hese FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitted. Further, these designations help to decrease the potential time to market and provide additional benefits across the FDA process that are expected to prove both medically and financially valuable. We continue to believe that CER-1236 represents a truly novel approach to cancer immunotherapy and are gratified by this regulatory milestone,鈥� said CERo Therapeutics CEO Chris Ehrlich.
FDA鈥檚 Fast Track Designation is designed to accelerate the development and review of therapies for serious or life-threatening conditions with unmet medical need. The designation provides CERo with the opportunity for increased FDA interactions, potential eligibility for priority review, and the ability to submit data on a rolling basis. Further, it also requires the Company to potentially provide expanded access to the investigational drug on an as-approved basis under pre-specified conditions.
The first-in-human, multi-center, open label, Phase 1/1b study, currently underway, is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or 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.聽 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).聽 Secondary outcome measures include pharmacokinetics (PK).
About CERo Therapeutics Holdings, 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鈥檚 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 (鈥淐ER-T鈥�). CERo believes the differentiated activity of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 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 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減ossible,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渟trive,鈥� 鈥渨ould鈥� 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鈥檚 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鈥檚 filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo鈥檚 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:
Chris Ehrlich
Chief Executive Officer
Investors:
CORE IR
FAQ
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