Anaveon doses first patient in a Phase I/II Study of ANV419 as monotherapy or in combination with check point inhibitors in patients with advanced melanoma

Anaveon doses first patient in a Phase I/II Study of ANV419 as monotherapy or in combination with check point inhibitors in patients with advanced melanoma

- OMNIA-1 is a Phase I/II study to determine the efficacy of ANV419 as monotherapy

and in combination with anti-PD1 or anti-CTLA4 antibodies in advanced melanoma -

Basel, February 2, 2023 – Anaveon, a clinical stage, immuno-oncology company, today announced the first patient has been dosed in the OMNIA-1 study - a Phase I/II study assessing the efficacy and safety of ANV419 for the treatment of advanced melanoma. ANV419 is a powerful, IL-2Rbeta selective IL-2 agonist, which has been specifically designed to enable the delivery of high dose IL-2.

“In the first-in-human study, the data demonstrate the ability of ANV419 to be delivered at high molar equivalents of IL-2 in a tolerable and convenient way, with preferential stimulation and expansion of NK and CD8+ T cells,” said Eduard Gasal, MD, Chief Medical Officer at Anaveon. “We are excited to continue the development of our next-generation IL-2 in patients with advanced melanoma.”

In the past decade, there has been steady progress in the development of targeted therapy and immunotherapy for metastatic cutaneous melanoma with a substantial increase in the 5‑year overall survival (OS) rates from less than 10% to up to 50%. Despite substantial progress, 30% to 70% of patients do not respond to initial anti-programmed death 1/ligand 1 (PD-1/L1) therapy, and approximately 25% eventually progress. Thus, the overall outlook for patients with metastatic cutaneous melanoma remains challenging and the development of new effective and tolerable therapy is needed¹.

About the OMNIA-1 study

This global, open label, randomized, parallel arm, Phase I/II study (ANV419-101) will enrol up to 130 patients with advanced cutaneous melanoma. The study consists of a monotherapy dose expansion part, followed by a combination part of ANV419 with anti-PD1 or anti-CTLA-4 in patients who have progressed on or following standard of care immunotherapy².

Anaveon expects to report initial safety and efficacy data of the OMNIA-1 study by early 2024.

Anaveon is conducting several Phase I/II trials in parallel in solid tumors and hematological malignancies. In addition, Anaveon continues its work in developing follow-on compounds to expand on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and expand into less immunogenic tumors. The Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.

¹Schadendorf D, van Akkooi ACJ, Berking C, et al. Melanoma. Lancet. 2018;392(10151):971-984.

²ClinicalTrials.gov, NCT05578872