• Thursday, March 16, 2023 @ 12:00 am

OMNIA-2 is a Phase I/II study evaluating ANV419 as monotherapy and in combination with daratumumab, or lenalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma

Anaveon, a clinical stage, immuno-oncology company, today announced the first patient dosed with ANV419 in the OMNIA-2 (ANV419-102) study - a Phase I/II study assessing the safety, tolerability and preliminary efficacy of ANV419 for the treatment of patients with relapsed / refractory multiple myeloma as monotherapy and in combination with daratumumab and hyaluronidase-fihj (1), or with lenalidomide plus dexamethasone. ANV419 is a powerful, IL-2Rb selective IL-2 agonist, which has been specifically designed to enable the delivery of high dose IL-2.

“In the first-in-human study of ANV419 (ANV419-001), 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 natural killer (NK) and cytotoxic CD8+ T cells,” said Eduard Gasal, MD, Chief Medical Officer at Anaveon. “In patients with multiple myeloma, the critical role of NK cells has been well described. ANV419 is expected to promote antitumor response via the preferential stimulation of NK and cytotoxic CD8+ T cells.”

About the OMNIA-2 study (2)
This open-label, Phase I/II adaptive design study is underway with sites in Europe and will enroll up to 52 patients with relapsed / refractory multiple myeloma. The study consists of an initial 8 week ANV419 monotherapy part, followed by randomization to ANV419 in combination with daratumumab and hyaluronidase-fihj, or lenalidomide plus low dose dexamethasone. Patients with symptomatic multiple myeloma who responded to previous treatment and received autologous stem cell transplant, or at least 2 lines of therapy are eligible to participate.

Anaveon expects to report initial data of the OMNIA-2 study in early 2024.

Anaveon is conducting multiple clinical trials in parallel to determine the clinical benefit of ANV419 in Oncology. In addition, Anaveon continues its work in developing follow-on compounds to build on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and increase efficacy against less immunogenic tumors. The Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.


  1. Accessed via a Compound Supply Agreement with Janssen Research & Development, LLC
  2. ClinicalTrials.gov, NCT05641324