FDA approves phase 1/2 clinical trial with ABX196 in patients with liver cancer ABX196 to be tested in combination with checkpoint inhibitor nivolumab to treat hepatocellular carcinoma
May 14, 2019
LA JOLLA, CA The U.S. Food and Drug Administration has approved an investigational new drug (IND) application for a phase 1/2 clinical trial of ABX196, a liver cancer therapy developed in the laboratory of Scripps Research Professor Luc Teyton, MD, PhD, and licensed to French pharmaceutical company Abivax.
The FDA approval allows Abivax testing of ABX196 in patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. ABX196 showed potent efficacy against HCC in preclinical testing.
The translation of basic research discoveries to the clinic is the greatest achievement we can hope for as clinician scientists. says Teyton, who is also a member of Abivax's Scientific Advisory Board. The use of ABX196 in the context of immunotherapy has been shown to be beneficial in multiple animal models of cancer, but the results with hepatocellular carcinoma are spectacular. We are looking forward to impacting the disease in patients, especially given the limitations of current therapies.
The open IND allows Abivax to test ABX196 in combination with nivolumab (Opdivo, Bristol-Myers Squibb), a checkpoint inhibitor, in a first phase 1/2 clinical trial to treat patients with HCC. The initial dose-escalation phase of the study will be conducted at the Scripps MD Anderson Cancer Center in San Diego, California, USA; additional leading cancer centers in the U.S. will be involved in the subsequent expansion phase of the study. The first patient is expected to be enrolled this summer.
We are thrilled to have been given the green light by FDA for our U.S. study. says Hartmut J. Ehrlich, MD, chief executive officer of Abivax. This open IND allows Abivax, in collaboration with leading key opinion leaders at internationally renowned U.S. 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 a synthetic glycolipid agonist of invariant natural killer T cells (iNKT) in a liposomal formulation. A phase 1 clinical trial conducted by Abivax in healthy volunteers has been completed and demonstrated safety and tolerability as well as a potent activation of iNKT cells. ABX196, 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 holds exclusive rights to ABX196 from Scripps Research, the University of Chicago, and Brigham Young University.
Despite the recent introduction of checkpoint inhibitors, hepatocellular carcinoma continues to be a substantial therapeutic challenge, as only about 20 percent of the treated patients show a response to these new drugs says Darren Sigal, MD, program director of GI Oncology at Scripps Clinic and Scripps MD Anderson Cancer Center in San Diego, and principal investigator of the study. While checkpoint inhibitors block a do not attack me' signal on cancer cells, ABX196 activates iNKT cells, a subpopulation of lymphocytes that is critical for mounting an effective immune response. The synergy between these two molecules carries substantial promise for improved outcomes for patients with this deadly cancer.
Checkpoint inhibitors like nivolumab are a leading class of therapeutic monoclonal antibodies that block certain endogenous proteins (PD-1/PDL-1) made by immune cells, such as T cells, as well as some cancer cells. These proteins effectively hijack the immune system, causing it to keep immune responses in check and preventing T cells from killing cancer cells. When these proteins are blocked, the brakes on the immune system are released and T cells are able to kill cancer cells much more efficiently. In some cancers, treatment with checkpoint inhibitors has been highly efficacious. However, due to the tumor micro-environment in other cancers, such as HCC, checkpoint inhibitors can have difficulties exerting their effects. ABX196 is intended as a drug that will potentiate the efficacy of checkpoint inhibitors by activating iNKT cells to kill tumor cells.
HCC is the most common form (75 to 90 percent) of primary liver cancer in adults. It typically occurs in the setting of chronic liver inflammation and/or cirrhosis and is closely linked to chronic viral infection such as hepatitis B or C, exposure to toxins such as alcohol, and to certain diseases such as non-alcoholic steatohepatitis (NASH).
The incidence of and deaths related to HCC are increasing in the United States and globally due to hepatitis B and C virus infections, as well as NASH. Prevalence data from 2018 show a total of 79,000 cases of HCC in the U.S. and G5 Europe (Germany, France, Italy, Spain and the UK), with 67,000 new cases, and a total of 260,000 cases in China with 338,000 new cases. Globally, there were 841,000 new cases of liver cancer (ranking it sixth of all reported cancers) and 782,000 fatalities (ranking it fourth) in 2018.
Currently, the American Cancer Society reports five-year survival rates in the U.S. of 31 percent for localized HCC, 11 percent for regional, and 2 percent for distant or metastatic, indicating a clear unmet medical need for improved therapies for HCC.
Cancer Immunology & Microbiology Teyton, Luc
Most recent headlines
05/01/2027
Worlds first 802.15.4ab-UWB chip verified by Calterah and Rohde & Schwarz to be ...
01/06/2026
January 6 2026, 05:30 (PST) Dolby Sets the New Standard for Premium Entertainment at CES 2026
Throughout the week, Dolby brings to life the latest innovatio...
02/05/2026
Dalet, a leading technology and service provider for media-rich organizations, t...
01/05/2026
January 5 2026, 18:30 (PST) NBCUniversal's Peacock to Be First Streamer to ...
01/04/2026
January 4 2026, 18:00 (PST) DOLBY AND DOUYIN EMPOWER THE NEXT GENERATON OF CREATORS WITH DOLBY VISION
Douyin Users Can Now Create And Share Videos With Stun...
02/03/2026
NBC Sports selected Imaginary Forces to create the main title sequence for the M...
02/03/2026
The NFL announces the launch of the NFL Draft Innovation Challenge, a new crowds...
02/03/2026
The World Teleport Association (WTA) has named Skyline Communications' DataMiner SatOps solution as a finalist for the 2026 Teleport Technology of the Year ...
02/03/2026
Ventum Tech announces a strategic partnership with Pixotope, a real-time graphic...
02/03/2026
Victory , a free, ad-supported sports streaming service, announces the launch of...
02/03/2026
Global powerhouse Delta Goodrem to represent Australia at this year's Eurovi...
02/03/2026
SBS brings together prominent voices to discuss rising social division and seek ...
02/03/2026
NITV Unveils Wednesday Night Sport Night
Media releases
A Midweek Hub for Blak Sport
Flagship NRL program Over The Black Dot moves to Wednesdays at 9:30pm
...
02/03/2026
Rohde & Schwarz demonstrates FR1-FR3 carrier aggregation, advancing 6G readiness Rohde & Schwarz and Qualcomm Technologies, Inc. have reached another pivotal ...
02/03/2026
MELBOURNE, Fla., March 2, 2026 - L3Harris Technologies (NYSE: LHX) today announc...
02/03/2026
Harvey Norman tops New Zealand's biggest ad spenders as retail leads and telcos and beverages sure Auckland March 3, 2026 - Nielsen's New Zealand'...
02/03/2026
aconnic AG (ISIN: DE000A0LBKW6), Munich, and Arqit Quantum Inc. (Nasdaq: ARQQ, A...
02/03/2026
Advanced Systems Group, LLC (ASG), a technology and services provider for media creatives and content owners, has appointed Jody Boatwright as Chief Strategy Of...
02/03/2026
Lightware, an industry leader in signal management, is reinforcing its commitment to simplifying complex AV environments with the continued evolution of its TPN...
02/03/2026
ZEISS Cinema opens its doors to an exclusive screening, filmmakers Q&A and hands-on showcase of the new ZEISS Aatma lens family on Tuesday, March 10, 6:00-9:00 ...
02/03/2026
To expand the creative potential of the compact Astera QuikBeam, DoPchoice introduces the SNAPBAG Round. The new light-shaping accessory transforms the powerfu...
02/03/2026
Douglas Dubler
On a rooftop in New York City, veteran photographer Douglas Dubler watched the sun's angle shift across the urban landscape, his internal cl...
02/03/2026
ZEISS is expanding its Otus ML lens family with the introduction of the new ZEISS Otus ML 1.4/35. This manual-focus lens is designed for photographers who live ...
02/03/2026
Matthews Studio Equipment now offers the new Dinkum Systems White FlexiMount and Phone Mount Kit, a compact, highly adaptable setup for mobile content creation...
02/03/2026
Luxembourg, February 26, 2026 - SES and Africa Mobile Network (AMN) have expande...
02/03/2026
02 03 2026 - Media release Ausfilm and Screen Australia launch joint UK market initiative
Ausfilm and Screen Australia have announced Partner with Australia (...
02/03/2026
Monday 2 March 2026
Saturday Night Live UK announces writing team
L-R: Jonno Johnson; Charlie Skelton; Celya AB; Omar Badawy; Gr inne Maguire; Laura Claxton; ...
02/03/2026
Back to All News
Netflix Unveils the Trailer for 53 Sundays, the New Film by Cesc Gay
Entertainment
02 March 2026
GlobalSpain
Link copied to clipboard
Dis...
28/02/2026
With two features seen in Formula 1 coverage, the broadcaster aims to bring view...
28/02/2026
Secretary of War Pete Hegseth addresses a crowd of approximately 1,500 L3Harris employees in Camden, Arkansas, as part of his Arsenal of Freedom tour....
28/02/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
28/02/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
28/02/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
28/02/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
28/02/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
28/02/2026
Berklee Presents Mambo Mania: Eguie Castrillo and the Berklee All-Stars Big Band...
28/02/2026
Berklee Announces Two New Summer Programs in Los Angeles The Berklee Music Business Program and Electronic Music Production and Sound Design Workshop bring imme...
28/02/2026
AI-RAN is moving from lab to field, showing that a software-defined approach is ...
28/02/2026
Autonomous networks - intelligent, self-managing telecommunications operations -...
28/02/2026
Back to All News
Final Trailer for BEASTARS Final Season Part 2' Roars Tow...
28/02/2026
New way to intentionally discover molecular glues could expand drug discovery Scripps Research scientists and colleagues show how drugs that eliminate certain d...
27/02/2026
The E.W. Scripps Company names Oliver Gray as Vice President, Network Sports and...
27/02/2026
The Gotham Sports App, the exclusive direct-to-consumer streaming home of MSG Networks and the YES Network, is now available for purchase through Prime Video fo...
27/02/2026
ESPN and the Horizon League announce a new multi-year, multi-platform media rights agreement, continuing a 38-year collaboration that began with the 1988 Midwes...
27/02/2026
At the 2026 NAB Show in Las Vegas, NETGEAR will highlight its new switch models and major updates to its Engage Controller software. The company's network d...
27/02/2026
Riedel Communications announces that Fondazione Teatro alla Scala has deployed a...
27/02/2026
Lyuno specializes in media localization, including translation, dubbing, subtitling, and voice-over services for a wide array of entertainment content. The comp...
27/02/2026
Chyron Weather 2.3, the latest edition of Chyron's weather visualization suite for broadcasters and meteorologists, recently launched.
The release includes...
27/02/2026
Telestream, which concentrates in media workflow technologies, announces expanded practical AI enhancements across its Vantage, Vantage Cloud, EDC, Stanza, and ...
FDA approves phase 1/2 clinical trial with ABX196 in patients with liver cancer ABX196 to be tested in combination with checkpoint inhibitor nivolumab to treat hepatocellular carcinoma
