Anaveon announces IND approval of ANV600-001 (EXPAND) Phase I/II clinical study

ANV600 combines a non-blocking aPD-1 antibody and an IL-2Rβ/γ selective agonist targeting IL-2 to tumor-specific T cells resulting in proliferation and increase of tumor-killing potential

Basel, 29 May 2024 – Anaveon, a clinical stage, immuno-oncology company, today announced that its Investigational New Drug (IND) application to conduct a Phase I/II study evaluating the safety and clinical activity of ANV600 has been accepted by the FDA. The Company will initiate the first two dose escalation cohorts with ANV600 monotherapy and combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA^ (pembrolizumab) as part of a multi cohort study to evaluate the safety and efficacy of ANV600 in multiple cancer indications.

ANV600 uses a non-blocking anti-PD-1 antibody to target a powerful  IL-2Rβ/γ selective IL-2 agonist to tumor-specific T cells, resulting in their proliferation and increase of tumor-killing potential. ANV600 is designed to administer in combination with approved PD-1 checkpoint inhibitors, thus enabling optimal dosing of IL-2 agonism and PD-1 blockade to maximize therapeutic benefit.

“Approval to start our first-in-human clinical study of ANV600 represents an important step towards validation of our approach,” said Eduard Gasal, M.D., Chief Medical Officer of Anaveon. “In preclinical studies, ANV600 has demonstrated marked efficacy and a favorable safety profile.  We are eager to bring this potential treatment option to patients.”

In March 2024, Anaveon entered into a clinical trial collaboration and supply agreement with MSD, to evaluate Anaveon’s wholly-owned drug candidate ANV600 in combination with KEYTRUDA in clinical trials. Under the terms of the agreement, MSD will supply KEYTRUDA. Anaveon retains all worldwide rights to ANV600.

KEYTRUDA^ is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.