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...
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...
20/01/2026
SVG Sit-Down: BitFire's Jim Akimchuk on the Future of Cloud, Remote, Softwar...
20/01/2026
From architecture to reality: What CBC's Milano Cortina 2026 workflows tell ...
20/01/2026
Milano Cortina 2026: Making the Winter Olympics and Paralympics workflow work fo...
20/01/2026
Countdown to Milano Cortina 2026: SVG Launches SportsTechLive Blog in Lead-up to...
20/01/2026
Grand finale: Rally Saudi Arabia pushes WRC to make the most of cameras and dron...
20/01/2026
State of Change: What's Happening in the Remote-Production Business?NEP Group, Game Creek Video, Dome Productions, Mobile TV Group, Program Productions exec...
20/01/2026
CFP National Championship 2026: A Look Back at SVG's Complete CoverageGo behind the scenes with ESPN, Game Creek Video, Van Wagner, and the champion Indiana...
20/01/2026
The Gotham, Film Independent, and Creators Coalition on AI Join Alliance
by Michelle Satter, Founding Senior Director, Sundance Institute's Artist Programs...
20/01/2026
The National Film and Video Foundation (NFVF), an agency of the Department of Sp...
20/01/2026
December, the first month of winter and the holiday season, has traditionally encouraged families to spend time together in front of the television. During this...
20/01/2026
During December, streaming's share of TV viewing in Mexico settled at 24.3%, an increase of 0.1 share points from the previous month.
Disclaimer: YUMI TV,...
20/01/2026
Christmas Day is Most-Streamed Day Ever with 55 Billion Viewing Minutes, led by...
20/01/2026
Share Share by:
Copy link
Facebook
X
Whatsapp
Pinterest
Flipboard...
20/01/2026
Disguise and ASB GlassFloor today announced a strategic partnership that turns the arena floor into a fully customizable interactive digital surface. This will ...
20/01/2026
Last summer, ITV celebrated the tenth anniversary of its popular reality dating show, Love Island. To ramp up the excitement of series 12 (launched in the UK on...
20/01/2026
Berklee's Mark Ethier Named One of SPIN's Most Influential People in Mus...
20/01/2026
Share Share by:
Copy link
Facebook
X
Whatsapp
Pinterest
Flipboard...
20/01/2026
Share Share by:
Copy link
Facebook
X
Whatsapp
Pinterest
Flipboard...
20/01/2026
Emergent, a provider of AI-powered media production solutions, today announced its presence at ISE 2026 in Barcelona, taking place February 3 6, where it will u...
20/01/2026
Back to All News
Netflix and Warner Bros. Discovery Amend Agreement to All-Cash Transaction
Business
20 January 2026
Global
Link copied to clipboard
All-C...
20/01/2026
Back to All News
Now You Can Play a Role in Our Live Events With Real-Time Voting
Elmar Nubbemeyer
VP, Member Product
Product
20 January 2026
Global
Link...
19/01/2026
CFP National Championship 2026: Indiana Football's Digital Crew Generate Hyp...
19/01/2026
CFP National Championship 2026: Van Wagner Relies on Experience for Indiana-Miam...
19/01/2026
CFP National Championship 2026: Game Creek Video Fields Premiere IP Compound for...
19/01/2026
CFP National Championship 2026: For a Slew of Studio Shows, ESPN Turns Hard Rock...
19/01/2026
CFP National Championship 2026: ESPN's Sweeping Live Game Production Leverag...
19/01/2026
The new L3Harris NOVA binocular system is the every-soldier goggle' - and the beginning of a new era for night-vison capability....
19/01/2026
The Majority of Those Surveyed Prefer to Buy Brands Who Advertise in Content Tha...
19/01/2026
Back to All News
Straight to Hell' Sets April 27 Premiere: Teaser Trailer,...
19/01/2026
New Workflow Enhancements for All Broadcast Pix Systems, Plus 4-Channel ISO Recording for Hybrid and Roadie Tyngsboro, Mass. - January 2025 - Broadcast Pix ann...
19/01/2026
Monday 19 January 2026
Sky News reinvents News at Ten for the modern audience with The Wrap
Sky News today announces The Wrap, a bold evolution of its 10pm ou...
19/01/2026
Back to All News
Netflix Announces the Series Nights & Days, Directed by Kamila...
19/01/2026
DPA Microphones is striking a new chord in piano miking with the debut of its DPK2015 Piano Stereo Kit, an out-of-the-box, plug-and-play miking solution that ta...
19/01/2026
DPA Microphones will present its 4099 CORE Instrument Microphone and redesigned...
19/01/2026
Trianel relies on Arvato Systems for future-proof data center operations
Moving to the cloud: Arvato Systems implements extensive IT migration project
Migrat...
19/01/2026
Celebrating 21 Years of the RT Choice Music Prize
RT Choice Music Prize
In association with IMRO and IRMA
Irish Album of the Year 2025 - Shortlist Announce...
18/01/2026
January 18 2026, 21:30 (PST) Dolby Cinema Arrives in Bengaluru: Dolby Laborator...
17/01/2026
Lightware, an industry leader in signal management, is helping to elevate the Google Meet experience with the introduction of an integration with Taurus UCX. Th...
17/01/2026
Clear-Com announced a strategic partnership with NETGEAR AV to offer four high-performance networking switches as original equipment manufacturer (OEM) solutio...
17/01/2026
QuickLink, a leading provider of award-winning video production and remote guest contribution solutions, today announced a new U.S. distribution partnership wit...
17/01/2026
NUGEN Audio announces the latest evolution of MasterCheck, its industry-trusted optimization plug-in for cross-platform mastering and loudness verification. Des...
17/01/2026
BHV has announced that it will highlight its new SportsBox remote vision mixer and picture processor at ISE in Booth #4H900 marking its official introduction in...
17/01/2026
Clear-Com will return to ISE 2026 to demonstrate its latest intercom solutions for broadcast, live production, and AV professionals. Exhibiting at Stand #4P700...
17/01/2026
Grass Valley, a leading provider in live production solutions, will exhibit at ISE 2026 in Barcelona from February 3 6, presenting its vision for how modern Bro...
17/01/2026
Utelogy Corporation, the global leader in connected workplace management, monitoring, control, automation and analytics closes out a record-breaking 2025. The c...
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
