Basel - 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-2R 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.

Contact:

Julia Wilson

Email: julia.wilson@anaveon.com

Tel: +44 (0)7818 430877

About Anaveon

Anaveon is a biotechnology company located in Basel, Switzerland. Using our immunological knowledge and expertise in protein engineering, we develop medicines to deliver meaningful benefits to cancer patients. Our lead compounds, ANV419 and ANV600, are currently in clinical trials in solid tumors.

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