for Therapies Targeting Cell-State Plasticity
We are developing a portfolio that is the direct output of our AURIGIN platform. We have identified a set of priority targets and programs that represent first-in-class and/or best-in-class opportunities for oncology and inflammatory diseases.
AUTX-703 our KAT2A/B program for Cancer
AUTX-703 is a first-in-class, oral KAT2A/B degrader, which is developed for the treatment of both hematologic malignancies and solid tumors. Leveraging AURIGIN we identified KAT2A/B as a key driver of cell plasticity and disease. KAT2A/B are lysine acetyltransferases that epigenetically reprogram cells to a more proliferative and plastic cell state to drive disease. We have validated the target in several disease models including AML, SCLC and NEPC. AUTX-703 has cleared two INDs and is initiating Phase 1 studies in hematologic malignancies including acute myeloid leukemia and myelodysplastic syndromes (MDS). In addition, the FDA granted Fast Track designation to AUTX-703 for the treatment of r/r AML.
Expanded Access Policy
Auron Therapeutics is committed to developing innovative, next-generation targeted therapies. At present, no investigational product candidates are available for Expanded Access. The only way to access investigational treatments is through participation in clinical trials, which are specifically designed to rigorously assess their safety and efficacy. Please be advised that our policy regarding Expanded Access is subject to change without prior notice.
We have fostered a culture that encourages our team to be curious, to think strategically and creatively, and to push the limits of science. We honor diversity and individuality, and are united by a single commitment to serve the patients and families who need new treatments.
Auron Therapeutics Announces AUTX-703 Granted Fast Track Designation by the FDA for Relapsed or Refractory Acute Myelogenous Leukemia
Newton, MA, February 24, 2025 – 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).
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