Anaveon gets IND approval for ANV600-001 (EXPAND) Phase I/II study

Anaveon, a clinical-stage immuno-oncology company, has announced that the FDA has accepted its Investigational New Drug (IND) application for a Phase I/II study of their innovative drug, ANV600. This study aims to evaluate the safety and clinical efficacy of ANV600, which combines an anti-PD-1 antibody with an IL-2Rβ/γ selective agonist to target tumor-specific T cells. This combination stimulates T cell proliferation and enhances their ability to kill cancer cells.

The upcoming study will commence with two initial dose escalation cohorts, testing ANV600 both as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by MSD (Merck & Co., Inc.). This multi-cohort study will assess the safety and efficacy of ANV600 across various cancer types. ANV600 is engineered to be administered alongside approved PD-1 checkpoint inhibitors, thereby optimizing the dosing of IL-2 agonism and PD-1 blockade to maximize therapeutic outcomes.

Eduard Gasal, M.D., the Chief Medical Officer of Anaveon, expressed optimism about this milestone. "The approval to initiate our first-in-human clinical study of ANV600 is a significant step in validating our approach," he stated. "Preclinical studies have shown that ANV600 is both effective and safe. We are excited to offer this potential treatment to patients."

In March 2024, Anaveon entered into a collaboration and supply agreement with MSD to evaluate ANV600 combined with KEYTRUDA in clinical trials. According to the agreement, MSD will provide KEYTRUDA, while Anaveon retains all global rights to ANV600.

Anaveon is based in Basel, Switzerland and specializes in developing innovative cancer treatments through advanced immunological and protein engineering techniques. Its leading compounds, ANV419 and ANV600, are currently undergoing clinical trials for solid tumors.

This development marks a crucial advancement in Anaveon's mission to create impactful cancer treatments, leveraging their expertise in immunology and protein engineering to benefit patients worldwide.