Prostate Neuroendocrine Carcinoma

Data demonstrate dose dependent survival advantage with AUTX-703 in primary patient-derived orthotopic AML model IND submissions on track for late 2024 NEWTON, MA, USA I December 09, 2024 I Auron Therapeutics , a biotechnology company focused on developing next-generation targeted therapies by identifying and inhibiting the oncogenic cell states of cancer, today 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. At ASH, the company presented cell line-based activity, as well as ex vivo and in vivo patient derived xenograft (PDX) data from AUTX-703 a potent, selective and orally bioavailable heterobifunctional degrader of KAT2A/B, a histone acetyltransferase that is associated with AML and other cancer types. Overall, treatment with AUTX-703 was well-tolerated and reversed the block in cellular differentiation, resulting in a significant survival advantage in a primary patient-derived orthotopic AML model. 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. “These are the first data to demonstrate AUTX-703’s potent degradation of KAT2A/B promoting cellular differentiation and leading to a significant survival advantage in a primary AML model,” said Kate Yen, Ph.D., Founder and Chief Executive Officer of Auron. “These data further validatate AURIGIN’s platform capabilities to identify promising oncology targets with potential in multiple cancer types as we prepare to submit multiple IND’s for AUTX-703 later this year.” In a poster titled, “AUTX703, a Novel and Potent KAT2A and KAT2B Protein Degrader, Induces Differentiation and Offers Survival Advantage in a Primary Human AML Xenograft Model,” treatment with AUTX-703 resulted in: About Auron Therapeutics Auron Therapeutics is a patient-centered, platform-powered, product-driven oncology company. Auron is leading the next generation of targeted cancer therapies by identifying and inhibiting the oncogenic cell states of cancer. Auron pioneered its AURIGIN™ platform, which uses AI and machine learning to compare normal cell states with cancerous cell states to identify novel cancer targets, optimal development models, and biomarkers to facilitate proper patient selection. Using AURIGIN, the Company is building a pipeline of small molecule targeted therapies, led by AUTX-703, which is being developed for the treatment of both solid tumors, including small cell lung cancer and neuroendocrine prostate cancer, and hematologic malignancies, including acute myeloid leukemia. For more information, please visit aurontx.com . SOURCE: Auron Therapeutics

This is the second Fast Track Designation granted to PT217 by the agency SAN DIEGO, Dec. 4, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). This is the second Fast Track Designation granted to PT217 by the FDA. Earlier this year, PT217 was granted Fast Track designation for extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor by the agency. PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma, including neuroendocrine prostate cancer (NEPC). In addition to Fast Track designation, PT217 was also granted orphan drug designations for the treatment of small cell lung cancer and neuroendocrine carcinoma (NEC), respectively. The multi-center Phase I/II clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of PT217 is also ongoing in China (CTR20242720). Earlier this year, Phanes entered into a clinical supply agreement with Roche to study PT217 in combination with Roche's anti-PD-L1 therapy, atezolizumab. ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Newton, MA, November 5, 2024 – Auron Therapeutics, a biotechnology company focused on developing next-generation targeted therapies by identifying and inhibiting the oncogenic cell states of cancer, today announced that the Company will present new preclinical data from its lead program AUTX-703 during a poster session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition from December 7-10, 2024 in San Diego, CA. 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. 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. ‍ Details for Auron’s poster presentation are below: • Abstract Title: AUTX703, a Novel and Potent KAT2A and KAT2B Protein Degrader, Induces Differentiation and Offers Survival Advantage in a Primary Human AML Xenograft Model • Poster Session: 802, Chemical Biology and Experimental Therapeutics • Session Date and Time: Sunday, December 8, 6:00 - 8:00 p.m. PT ‍ About Auron Therapeutics Auron Therapeutics is a patient-centered, platform-powered, product-driven oncology company. Auron is leading the next generation of targeted cancer therapies by identifying and inhibiting the oncogenic cell states of cancer. Auron pioneered its AURIGIN™ platform, which uses AI and machine learning to compare normal cell states with cancerous cell states to identify novel cancer targets, optimal development models, and biomarkers to facilitate proper patient selection. Using AURIGIN, the Company is building a pipeline of small molecule targeted therapies, led by AUTX-703, which is being developed for the treatment of both solid tumors, including small cell lung cancer and neuroendocrine prostate cancer, and hematologic malignancies, including acute myeloid leukemia. For more information, please visit aurontx.com. ‍ ### ‍ Investor Contact: Renee Leck THRUST Strategic Communications renee@thrustsc.com