FDA Clears Investigational New Drug Application of AVS100 in Solid Tumors


The FDA has granted clearance to a promising new agent, AVS100, for a phase 1 trial to target solid tumors.

  • AVS100, a potential treatment for locally advanced or metastatic solid tumors, will enter a phase 1 clinical trial.
  • AVS100 has shown preclinical efficacy in suppressing tumor growth by impacting macrophages.
  • The trial will assess AVS100's safety, tolerability, pharmacokinetics, and dosage range, both alone and combined with pembrolizumab (Keytruda).

The FDA cleared an investigational new drug application (IND) for AVS100 as a potential treatment option for locally advanced or metastatic solid tumors.1 AVS100 will be evaluated in a phase 1 clinical trial.1

"The FDA clearance of our IND for AVS100 marks an amazing step for our company towards the fulfillment of our mission.We are excited to advance this promising new therapy into the clinic to address the disease burden for the benefit of patients, and our transition to a viable clinical stage biotech. AVS100 has demonstrated significant preclinical efficacy, remarkable safety, and durability in numerous invivo studies." said Karthik Musunuri, chief executive officer, co-founder, and director of Avstera Therapeutics, in a press release.

AVS100 is a novel, highly selective, and orally bioavailable, isoxazole-3-hydroxamate-based HDAC6 inhibitor. Preclinical findings have displayed the unique ability of AVS100 in suppressing the polarization of macrophages toward pro-tumoral phenotypic pathways. Further, AVS100 is AMES-negative and has also demonstrated a strong safety profile showing no major adverse events.

In the phase 1a/b open-label, dose-escalation, confirmatory trial, investigators will evaluate AVS100 in patients with locally advanced or metastatic solid tumors. The goals of the study are to characterize the safety, tolerability, pharmacokinetics, and maximumtolerated dose of AVS100 alone and in combination with pembrolizumab.

The incidence of adverse events, including dose-limiting toxicities in the monotherapy and combination arms, serves as the primary end point of the trial. Secondary end points will assess pharmacokinetics, objective response rate using RECIST v1.1, and progression-free survival.

Initiation of the phase 1a/b trial is expected in the first half of 2024 and will be led by principal investigator Apostolia M. Tsimberidou, MD, PhD, FASCO, FAAAS, professor of medicine at MD Anderson Cancer Center, Houston, TX.

"FDA clearance of our IND for AVS100 represents a significant milestone for Avstera's mission in providing state of the art oncological agents to tackle solid tumors,”said Ajay Raju, co-founder and director of Avstera Therapeutics, in a press release.

Avstera Therapeutics announces FDA clearance of IND application for AVS100, a novel highly selective HDAC6 inhibitor targeting solid tumors. News release. Avstera Therapeutics Corp. December 18, 2023. Accessed December 18, 2023. https://tinyurl.com/3dpwwd2a
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