Abivax secures FDA approval for Phase I/II trial with ABX196 in HCC

14th May 2019 (Last Updated May 14th, 2019 00:00)

Abivax and Scripps Research have secured approval from the US Food and Drug Administration (FDA) to start a phase 1/2 clinical trial with ABX196 in patients with hepatocellular carcinoma (HCC).

Abivax and Scripps Research have secured approval from the US Food and Drug Administration (FDA) to start a Phase I/II clinical trial with ABX196 in patients with hepatocellular carcinoma (HCC).

The US regulator accepted an investigational new drug application for ABX196, which demonstrated potent efficacy in HCC animal models.

ABX196, an invariant Natural Killer T cell (iNKT) agonist, will be tested in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) to treat HCC.

The clinical trial will be initiated this summer at Scripps MD Anderson Cancer Center in San Diego, California.

"This open IND allows Abivax to explore the clinical potential of our iNKT agonist ABX196 to broaden and potentiate the activity of the checkpoint inhibitor nivolumab."

The study will also be carried out at further cancer centers in the US in the later expansion phase.

ABX196’s potential for cancer therapy has been demonstrated in preclinical studies. Abivax said the synthetic glycolipid agonist, both alone and in combination with a checkpoint inhibitor, showed a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in mice with HCC.

Abivax owns exclusive rights to ABX196 from Scripps Research, the University of Chicago, and Brigham Young University.

Abivax CEO Hartmut Ehrlich said: “This open IND allows Abivax, in collaboration with leading key opinion leaders at internationally renowned US cancer centers of excellence, to explore the clinical potential of our iNKT agonist ABX196 to broaden and potentiate the activity of the checkpoint inhibitor nivolumab.

“Based on its unique mechanism of action and exciting preclinical data in several cancer models, we believe ABX196 is a promising immunotherapeutic product candidate for patients with liver cancer that may also have potential in other cancers.”

ABX196 is Abivax’ second compound in clinical development after its front-runner ABX464 for inflammatory diseases.

The company uses its antiviral and immune enhancing platforms to optimise candidates for the treatment of ulcerative colitis and other inflammatory diseases, viral diseases and liver cancer.