Results from Abivax Phase 1/2 Clinical Study on ABX196 in Liver Cancer Show Good Tolerance and Signals Promising Clinical Benefit and Have Been Selected for Presentation at ASCO GI Cancers Symposium 2022

  • ABX196 is the second Abivax compound in clinical development after lead drug candidate ABX464

  • ABX196 was well tolerated and showed promising signs of clinical benefit in heavily pretreated hepatocellular cancer patients

  • The results of the phase 1/2 study ABX196 have been selected for presentation at the 2022 ASCO Gastrointestinal Cancers Symposium (ASCO GI Cancers Symposium)

  • The detailed data of the abstract submitted to the ASCO GI Cancer Symposium will be published from January 18, 2022, in accordance with the official ASCO embargo policy.

PARIS, FRANCE / ACCESSWIRE / November 30, 2021 / Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing new therapies modulating the immune system to treat chronic inflammatory diseases, viral infections and cancer, today reports good tolerance and promising signals of clinical benefit resulting from its phase 1/2 clinical study conducted with ABX196. In this study, heavily pretreated hepatocellular cancer (HCC) patients received ABX196 in combination with the checkpoint inhibitor nivolumab, including patients who were previously exposed to checkpoint inhibitor treatments. These results support the further clinical development of ABX196 in HCC.

The Company further announces today that the dose escalation results of this Phase 1/2 study with ABX196 have been selected for presentation at the renowned ASCO Gastrointestinal Cancers Symposium, to be held January 20-22, 2022 in San Francisco, California, United States. . The ASCO GI Cancers Symposium is one of the most important international conferences to present and discuss the latest, most innovative and promising research advances in the field of gastrointestinal cancer. It is organized annually by the American Society of Clinical Oncology (ASCO), the world’s leading cancer research organization.

Darren Sigal, MD, gastrointestinal oncology program director at Scripps MD Anderson Cancer Center in San Diego, a physician at the Scripps Clinic and principal investigator of the study said: “We are pleased to see a good safety profile as well as clinical benefit signals in liver cancer patients treated with a combination of ABX196 and the checkpoint inhibitor nivolumab. The selection of the results of this phase 1/2 trial for poster presentation at the ASCO GI Cancers 2022 Symposium validates these promising first data generated in the dose escalation phase of the study. Checkpoint inhibitor to be evaluated in HCC, activating the iNKT cell, a key anti-cancer immune cell. We look forward to presenting and discussing these results with the world’s leading experts in oncology at the ASCO GI Cancers Symposium. “

In accordance with ASCO’s embargo policy, detailed clinical data and summary conclusions will be released from January 18, 2022. Abivax will make clinical study results publicly available as soon as the embargo is officially lifted. .

A phase 1/2 study of ABX196 in combination with the checkpoint inhibitor nivolumab in patients with previously treated hepatocellular carcinoma
The Phase 1/2 clinical trial in hepatocellular carcinoma, the most common form of liver cancer, is being conducted at two renowned cancer centers of excellence in the United States, the Scripps MD Anderson Cancer Center in San Diego , California, and the MD Anderson Cancer Center. in Houston, Texas. In this trial, ABX196, a Natural Killer T cell invariant agonist (iNKT), is administered with the checkpoint inhibitor nivolumab (Opdivo (R), Bristol Myers Squibb) to assess the safety and potential beneficial effects of this test. combination therapy. Patients who previously failed checkpoint inhibitors were included in the study which consists of two phases: a dose escalation phase and a subsequent expansion phase.

Based on the first result, the Company is currently evaluating the next steps for the future clinical development of ABX196 in HCC, also considering the availability of the required funding or the desirability of a license agreement.

About ABX196
ABX196 is a synthetic glycolipid agonist of Invariant Natural Killer T cells (iNKT) in a liposomal formulation. A phase 1 clinical trial of Abivax in healthy volunteers has been completed and has demonstrated safety and tolerability as well as potent activation of iNKT cells. Preclinical studies have demonstrated the potential of ABX196 for the treatment of cancer: ABX196, both alone and in combination with a checkpoint inhibitor, has shown a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in a mouse model of HCC. Abivax owns the exclusive rights to ABX196 from Scripps Research, the University of Chicago and Brigham Young University.

About Abivax (
Abivax, a clinical-stage biotechnology company, is developing new therapies that modulate physiological inflammation and immunological pathways to treat patients with chronic inflammatory diseases, viral infections and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Ticker: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe chronic inflammatory diseases and ABX196 to treat hepatocellular carcinoma. More information about the company is available at Follow us on Twitter @ABIVAX_.


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This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) regarding certain of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors which have been deemed reasonable, these forward-looking statements, forecasts and estimates are subject to to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in these forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers in application of its legal obligations, including its registration document (Universal Registration Document). Particular attention should be given to potential accelerations of clinical and pharmaceutical development, including further evaluation by society, regulatory agencies and ethics committees of preclinical, pharmacokinetic, carcinogenic, toxic, CMC, clinical data. In addition, these forward-looking statements, forecasts and estimates speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes of which the Company is aware, except as required by law.
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