AUTX-703 / Auron Therap - LARVOL DELTA

Auron Presents Preclinical Data Highlighting the Activity of AUTX-703 in Prostate Cancer at 2025 AACR Annual Meeting (GlobeNewswire) - "Using a series of experiments, Auron demonstrated activity with AUTX-703, its oral, potent and selective degrader targeting KAT2A/B in cell lines and patient derived organoid models (PDXO) of neuroendocrine prostate cancer (NEPC) and castrate resistant prostate cancer (CRPC). In NEPC cell lines and PDXO models treated for up to 21 days, AUTX-703 mediated potent KAT2A/KAT2B degradation, inhibited cell growth and induced cell state differentiation. AUTX-703 alone or in combination with enzalutamide was also found to induce cell differentiation in androgen receptor (AR) sensitive and AR resistant prostate cancer cell lines."

Preclinical • Castration-Resistant Prostate Cancer

AUTX-703, a novel and potent KAT2A and KAT2B protein degrader, induces differentiation and provides a potential therapeutic opportunity in subtypes of prostate cancer (AACR 2025) - "Our studies validate KAT2A and KAT2B as key drivers of tumor cell state plasticity. Degradation of KAT2A and KAT2B with AUTX-703 induces a more differentiated cell state and inhibits growth in NEPC and CRPC models. These data support progression of AUTX-703 into clinical development for NEPC and targeting KAT2A and KAT2B in the treatment of anti-androgen resistant prostate cancer."

Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: Auron Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Auron Presents New Preclinical Data for AUTX-703 in Small Cell Lung Cancer (SCLC) (GlobeNewswire) - "Auron Therapeutics,...today announced data from a poster presentation at the 2025 Hot Topic in Basic and Translational Science: Small Cell Lung Cancer Meeting in New York, NY....The poster presented data from AUTX-703, a potent, selective and orally bioavailable heterobifunctional degrader of KAT2A/B, an AURIGIN-identified histone acetyltransferase driving small cell lung cancer (SCLC) and other tumor types....Specifically, the poster findings demonstrated: In SCLC cell lines, AUTX-703 treatment induces lasting effects, with prolonged treatment (over 100 days) driving a persistent epithelial transition and reduction in ASCL1 and L-MYC neuroendocrine markers. In SCLC patient-derived xenograft organoid (PDXO) models, AUTX-703 potently inhibits in vitro organoid and in vivo tumor growth and is well tolerated with oral dosing."

Preclinical • Small Cell Lung Cancer

Auron Therapeutics Announces Poster Presentation at 2025 AACR Annual Meeting (GlobeNewswire) - "Auron Therapeutics...announced that the Company will present updated preclinical data from its lead program, AUTX-703, during a poster session at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025 in Chicago, IL. Auron will present data highlighting the activity of AUTX-703, its oral, potent and selective degrader targeting KAT2A/B in cell lines and patient derived organoid models (PDXO) of neuroendocrine prostate cancer (NEPC) and castrate resistant prostate cancer (CRPC)."

Preclinical • Castration-Resistant Prostate Cancer • Neuroendocrine Carcinoma

Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS (clinicaltrials.gov) - P1 | N=69 | Not yet recruiting | Sponsor: Auron Therapeutics, Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

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

Fast track • New trial • Acute Myelogenous Leukemia

Auron Therapeutics Announces FDA Clearance to Initiate Clinical Development of AUTX-703 and Completion of Series B Financing (GlobeNewswire) - "Auron Therapeutics...announced progress for its lead KAT2A/B program and clinical candidate, AUTX-703, and the completion of a $27 million Series B financing. Auron has received clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and is initiating clinical development of AUTX-703 in hematological malignancies....Proceeds from the raise will be used to advance AUTX-703 through a Phase 1 clinical proof-of-concept trial in AML, which will begin enrolling patients in the first quarter of this year. In addition, funds will be used to evaluate the therapeutic potential of targeting KAT2A/B in autoimmune disease and advance drug discovery efforts of novel EMT tumor targets identified using AURIGIN."

Financing • IND • New P1 trial • Acute Myelogenous Leukemia • Immunology

AUTX703, a Novel and Potent KAT2A and KAT2B Protein Degrader, Induces Differentiation and Offers Survival Advantage in a Primary Human AML Xenograft Model (ASH 2024) - "These data provide evidence that degradation of KAT2A and KAT2B can reverse the block in cellular differentiation in primary patient AML cells which could provide therapeutic benefit to patients. A Phase 1 clinical trial testing the safety and tolerability of AUTX-703 is planned in AML."

Preclinical • Acute Myelogenous Leukemia • Oncology • CD34 • CD86 • ITGAM

Auron Presents New Preclinical Data for AUTX-703 in AML at ASH Annual Meeting (GlobeNewswire) - "Auron Therapeutics...announced data from its lead program, AUTX-703, presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA....Auron is on-track to submit multiple Investigational New Drug (IND) applications for AUTX-703 in late 2024 for the initiation of clinical development in early 2025....Selective degradation of KAT2A and KAT2B induces monocytic differentiation and inhibits cell proliferation in an AML cell line and ex vivo primary AML patient samples. Strong degradation of KAT2A and KAT2B in bone marrow and spleen in AML PDX model with dose dependent recovery. Reduction in hCD45+/hCD34+ blasts and increased myeloid differentiation in peripheral blood, bone marrow and spleen in AML PDX model."

Preclinical • Acute Myelogenous Leukemia

Auron to Present New Preclinical Data for AUTX-703 at 2024 ASH Meeting (GlobeNewswire) - "Auron will present acute myeloid leukemia (AML) cell line-based activity, as well as ex vivo and in vivo patient derived xenograft data from AUTX-703, its oral, potent and selective degrader targeting KAT2A/B, a histone acetyltransferase that is associated with AML, among other cancers."

Preclinical • Acute Myelogenous Leukemia

AUTX-703, a novel and potent KAT2A and KAT2B protein degrader, induces profound cell state changes and inhibits growth in Small Cell Lung Cancer (SCLC) model systems (EORTC-NCI-AACR 2024) - "Overall, these data validate KAT2A/B as key drivers of cell state plasticity in SCLC, and pharmacologic targeting of KAT2A/B by AUTX-703 is a novel therapeutic approach in the treatment of SCLC by inducing cell state differentiation and growth inhibition."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Auron Presents New Preclinical Data for Lead Program AUTX-703 Across Multiple Cancer Types (GlobeNewswire) - "Auron Therapeutics...announced data from poster presentations at the EORTC-NCI-AACR (ENA) Symposium and Prostate Cancer Foundation (PCF) Annual Scientific Retreat....In a series of experiments, Auron showed that treatment with AUTX-703 potently degraded KAT2A/B, inhibited tumor growth, and induced a more differentiated cell state across models of SCLC, NEPC and CRPC. Auron is on-track to submit an Investigational New Drug (IND) application for AUTX-703 in late 2024 for initiation of clinical development in early 2025."

IND • Preclinical • Castration-Resistant Prostate Cancer • Neuroendocrine Tumor • Pancreatic Cancer • Small Cell Lung Cancer

AUTX703, a Highly Potent and selective KAT2A and KAT2B Protein Degrader, Induces Cell State Changes and Inhibits Growth in NEPC and SCLC cancers (PCF 2024) - No abstract available

Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Auron Announces Poster Presentation at 2024 PCF Annual Scientific Retreat (GlobeNewswire) - "Auron Therapeutics...announced that the Company will present updated preclinical data from its lead program during a poster session at the 31st Annual Prostate Cancer Foundation (PCF) Annual Scientific Retreat from October 24-26, 2024 in Carlsbad, CA. At PCF, Auron will present in vitro and in vivo data from AUTX-703, its oral, potent and selective degrader of KAT2A/B that is being developed for the treatment of AML and neuroendocrine carcinomas including SCLC and NEPC."

Preclinical • Acute Myelogenous Leukemia • Neuroendocrine Tumor • Prostate Cancer • Small Cell Lung Cancer

Auron to Present AUTX-703 Preclinical Data 2024 ENA Symposium (GlobeNewswire) - "Auron Therapeutics...announced that the Company will present updated preclinical data from its lead program during a poster session at the 36th EORTC-NCI-AACR (ENA) Symposium from October 23-25, 2024 in Barcelona, Spain. At ENA, Auron will present in vitro and in vivo data from AUTX-703 its oral, potent and selective degrader targeting KAT2A/B, a histone acetyltransferase that is associated with multiple tumor types, including SCLC. Auron is on-track to submit an Investigational New Drug (IND) application for AUTX-703 in late 2024 for initiation of clinical development in early 2025."

IND • Preclinical • Small Cell Lung Cancer

Auron Presents Preclinical Data at American Chemical Society Annual Meeting (GlobeNewswire) - "Auron Therapeutics...shared preclinical data showcasing the strength of the company’s medicinal chemistry capabilities....As shown with AUR101, degradation of KAT2A/KAT2B inhibits growth and induces cell state change towards a more terminally differentiated state across both AML and SCLC models. While AUR101 had the desired in vitro potency, it lacked adequate in vivo properties, leading Auron scientists to design compounds with better properties to advance into in vivo models....Auron is on-track to submit an Investigational New Drug (IND) application in late 2024 for initiation of clinical development in early 2025."

IND • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Auron Announces Oral Presentation on Preclinical Data from Proprietary AURIGIN Platform at the AI in Biomedicine Keystone Symposia (GlobeNewswire) - "Auron Therapeutics...announced an oral presentation on the company’s proprietary AURIGIN platform at the AI in Biomedicine Keystone Symposia held May 1-3, 2024....As highlighted in the presentation, Auron built AURIGIN to identify the drivers of tumor plasticity and altered cellular state, and to develop small molecule therapies that selectively address the causative genes behind those altered cell states....AUTX-703 is progressing in IND-enabling studies, and the company expects to submit an Investigational New Drug (IND) application by the end of 2024."

IND • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Auron Unveils Preclinical Data Supporting its Lead Program and Ability of its AURIGIN Platform to Generate Targeted Cancer Therapies at AACR Annual Meeting (GlobeNewswire) - "Auron Therapeutics...announced two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting....Auron shared preclinical data from its program targeting KAT2A/B, an AURIGIN-identified histone acetyltransferase driving small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and acute myeloid leukemia (AML). These data led to the nomination of AUTX-703, an orally available and selective KAT2A/B degrader development candidate, for which Auron expects to file an IND in 2024....In a separate poster presentation...Auron highlighted the integration of its developmental biology expertise with AI and machine learning (ML) algorithms and multi-omics database into a platform that can compare normal cell states to cancer cell states."

IND • Preclinical • Acute Myelogenous Leukemia • Neuroendocrine Tumor • Prostate Cancer • Small Cell Lung Cancer

Auron Announces Poster Presentations at 2024 AACR Annual Meeting (GlobeNewswire) - "Auron Therapeutics...announced that the Company will present an overview of its proprietary AURIGIN™ platform and the first preclinical data from its lead program during two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2024...At AACR, Auron will also present in vitro and in vivo data from its first-in-class, novel program targeting KAT2A/B, a histone acetyltransferase identified by AURIGIN that is associated with multiple tumor types. The Company generated preclinical data showing that degradation of KAT2A/B results in potent tumor-growth inhibition in primary models of small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and acute myeloid leukemia (AML). These data led to the subsequent design of AUTX-703..."

Preclinical • Acute Myelogenous Leukemia • Neuroendocrine Tumor • Prostate Cancer • Small Cell Lung Cancer

Auron Selects First Development Candidate for its Portfolio of Next-Generation Targeted Cancer Treatments from its Novel AURIGIN Platform (GlobeNewswire) - "Auron Therapeutics...announced the nomination of its first development candidate, AUTX-703. Using its proprietary AURIGIN platform, Auron identified a key driver of tumor cell plasticity and discovered AUTX-703, a potent, selective, orally bioavailable small molecule degrader of that target...'The selection of AUTX-703 is a significant milestone for Auron, validating our initial scientific hypothesis and the utility of our AURIGIN platform. I am extremely proud of what this team has accomplished in just a few years since our founding, and we look forward to sharing more about AURIGIN at AACR in April.'....'The selection of AUTX-703 is an important step toward broadly applying our AURIGIN platform for the development of a range of next-generation targeted cancer therapies.'"

New molecule • Preclinical • Acute Myelogenous Leukemia • Genito-urinary Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor