Auron Therapeutics Announces AUTX-703 Granted Fast Track Designation by the FDA for Relapsed or Refractory Acute Myelogenous Leukemia

Auron Therapeutics, a clinical-stage biotechnology company targeting cell-state plasticity to improve patient outcomes in oncology and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AUTX-703 for the treatment of patients with relapsed or refractory (r/r) acute myelogenous leukemia (AML).
AUTX-703 is a novel, first-in-class, oral KAT2A/B degrader discovered and developed by Auron using its AURIGIN™ Platform. The Company has previously presented preclinical data supporting the ability of AUTX-703 to provide a significant survival advantage in AML. Following the FDA's recent clearance of its Investigational New Drug (IND) application, Auron plans to initiate clinical development of AUTX-703 in hematological malignancies in the first quarter of 2025.
'We are gratified by the FDA's recognition of AUTX-703's potential as an important, novel treatment option for relapsed or refractory AML patients, a community that remains in desperate need of new therapies,' said Kate Yen, Ph.D., Founder and Chief Executive Officer of Auron. 'The FDA Fast Track Designation underscores the urgent need for innovative treatments for these patients and this milestone comes at a pivotal moment as we prepare to advance AUTX-703 into the clinic. Our team is energized by the potential to bring a first-in-class therapy to patients who have limited effective options today, while simultaneously exploring the broader applications of KAT2A/B modulation.'
The FDA's Fast Track program is designed to facilitate the development and expedite the review of medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates more frequent interactions with the FDA over the course of a drug's development and enables Accelerated Approval and Priority Review eligibility, if relevant criteria are met.
AML is an aggressive blood cancer characterized by the rapid growth of abnormal cells that build up in the bone marrow and interfere with normal blood cell production. Patients with relapsed or refractory AML face particularly poor outcomes, with five-year survival rates of approximately 10%1, highlighting the critical need for novel therapeutic approaches.
About Auron Therapeutics
Auron Therapeutics is a platform-powered, product-driven company targeting cell-state plasticity to improve patient outcomes in oncology and inflammatory disease. Auron pioneered its AURIGIN™ platform, which uses AI and machine learning to compare cell states and identify novel drug targets, optimal development models, and biomarkers to facilitate proper patient selection, ultimately accelerating the development of effective and durable therapies. Using AURIGIN, the Company is building a pipeline of small molecule targeted therapies, led by a first-in-class, oral KAT2A/B degrader, AUTX-703, which is being developed for the treatment of both hematologic malignancies and solid tumors. For more information, please visit aurontx.com and follow us on LinkedIn.
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