Avstera Therapeutics Corp has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug application (IND) for AVS100, a novel oral HDAC6 inhibitor intended for treating locally advanced or metastatic solid tumors in a Phase I clinical study.

Karthik Musunuri, CEO & Co-Founder, Director of Avstera Therapeutics, expressed excitement about the FDA clearance, stating that it marks a significant step towards fulfilling the company's mission. Musunuri highlighted AVS100's promising preclinical efficacy, safety, and durability observed in numerous in-vivo studies.

AVS100 is an orally bioavailable HDAC6 inhibitor with a unique isoxazole-3-hydroxamate base. In preclinical trials, AVS100 demonstrated the ability to suppress the polarization of macrophages toward pro-tumoral phenotypic pathways. This immunomodulatory function is of particular interest as tumor-associated macrophages can constitute a substantial portion of solid tumor cell mass. AVS100 has shown a strong safety profile in animals, including GLP toxicology studies in dogs and rats.

Ajay Raju, Co-Founder & Director of Avstera Therapeutics, celebrated the IND approval as a significant milestone in providing advanced oncological agents to tackle solid tumors. Raju commended the efficiency of the team in advancing to First-in-Human (FIH) trials in just over a year since their seed round.

Alejandro Villagra, PhD, Georgetown University Associate Professor and Co-Inventor of AVS100, expressed the potential of selective HDAC6 inhibitors, like AVS100, in enhancing response rates for patients undergoing immunotherapy. Villagra, who serves on Avstera's Scientific Advisory Board (SAB), highlighted the importance of targeting tumor-associated macrophages in overcoming resistance to existing immune checkpoint blockade (ICB) therapies.

The Phase Ia/b clinical trial for AVS100 will target locally advanced or metastatic solid tumors. It is an open-label, dose-escalation, and confirmation study aiming to characterize the safety, tolerability, pharmacokinetics, and Maximum Tolerated Dose (MTD) of AVS100 as a monotherapy and in combination with pembrolizumab. The trial's primary endpoints include evaluating adverse events, dose-limiting toxicities (DLTs), pharmacokinetics, Objective Response Rate (ORR), and Progression-Free Survival (PFS). Avstera also plans to assess multiple exploratory biomarkers, including conducting multi-omics analyses on patient samples.

The Phase Ia/b clinical trial is scheduled to commence in the first half of 2024, with Dr. Apostolia M. Tsimberidou, MD, PhD, FASCO, FAAAS, Professor of Medicine at MD Anderson Cancer Center, Houston, TX, serving as the principal investigator.

 

 

Source: prnewswire.com

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