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 ...
07/10/2026
Dalet, a leading technology and service provider for media-rich organizations, today announced the latest Long-Term Supported (LTS) release of Dalet Flex. Build...
06/09/2026
June 9 2026, 23:00 (PDT) Dolby and MagentaTV Bring Fans Closer to the FIFA Worl...
19/08/2026
As the cost of IP nears price parity with traditional SDI, Reynolds argues that ...
19/08/2026
A private 5G bubble was chosen instead of traditional broadcast RF for the race ...
19/08/2026
(L-R) Rafael Manuel and Isabel Sicat attend the Filipi ana premiere during the 2026 Sundance Film Festival at The Ray Theatre on January 23, 2026, in Park Cit...
19/08/2026
Studio owners invited to have their say on rates cuts
The Music Producers Guild (MPG) are inviting UK-based studios to take part in an in-depth survey that ...
19/08/2026
Vintage-inspired desktop interface revealed
Harrison's latest hardware offering sees them head into the world of audio interfaces, delivering a 10-in/12...
19/08/2026
Granular effect remains locked to scale and tempo
Described as your dream granular effect , Minimal Audio's latest creation is capable of turning any s...
19/08/2026
First polyphonic SWAM instrument incoming
Audio Modeling's latest physical-modelling orchestral instrument is just around the corner, and is now availab...
19/08/2026
World Cup Games Generate 84 Billion Minutes Across FOX, Fox Sports 1 and NBCU...
19/08/2026
July brought typical peak-holiday drops in viewership, driven primarily by viewers stepping away from screens and a visible decline in reach across both traditi...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Henry joins BCE as the company accelerates its commercial strategy and expands its international presence across the media, broadcast and technology markets. He...
19/08/2026
iWedia, a leading provider of software solutions for connected TV devices, today announced a major milestone in Android platform optimization with the successfu...
19/08/2026
NTP Technology announces that ST 2110-30 audio-over-IP connectivity with AES67 and RAVENNA capabilities is now available for the brand's world-class audio i...
19/08/2026
Net Insight has been selected to provide its Nimbra platform by the service provider Big Blue Marble, formerly ORS Group, as the core media transport solution f...
19/08/2026
LiveU has supported Coventry City FC and several other top-flight UK football clubs through one of their most demanding live production challenges of the year, ...
19/08/2026
Nature Seekers Documentary Shot with Blackmagic URSA Cine 12K LF
Brie Clayton August 18, 2026
0 Comments
Filming endangered turtles required camera...
19/08/2026
Neyrinck Brings D-Control Consoles Back to Life on Apple Silicon with D-Control ...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Share
Copy link
Facebook
X
Linkedin
Bluesky
Email...
19/08/2026
Riedel Communications today announced that Edith Cowan University (ECU) in Perth, Australia, implemented a comprehensive communications infrastructure that brin...
19/08/2026
QuickLink, a leading provider of award-winning video production and remote guest contribution solutions, will spotlight a major leap forward in remote guest con...
19/08/2026
Integrated platform melds media asset management, playout automation and newsroom workflows
EMAM, PlayBox Neo and SNEWS have officially launched Nuvex, a conne...
19/08/2026
Screen Australia releases the Private Investment Toolkit to strengthen screen in...
19/08/2026
Do Aussies truly value local content? Unpacking Screen Currency 2026 with Deirdr...
19/08/2026
Wednesday 19 August 2026
Sky gives sports fans the chance to watch multiple liv...
19/08/2026
On Saturday September 5 Katie Taylor will step into the ring for the fight of her life against Flora Pili in front of 80,000 fans in Croke Park. A legendary fig...
18/08/2026
SportStream 2026, a free three-day virtual event, will take place September 15-17. One registration provides access to all three days of live programming and on...
18/08/2026
BeckTV will introduce BeckFlow to the European market at IBC2026, demonstrated on the Providius stand (10.F53).
BeckFlow is a web-based schematic documentation...
18/08/2026
Boland Communications will introduce a SMPTE ST 2110 input option for its 4K monitors at IBC2026, along with a new 55-inch super-narrow bezel display for video ...
18/08/2026
Dolby Laboratories and the Seattle Seahawks have announced a partnership integrating Dolby OptiView into the Seahawks' live streaming coverage, making the S...
18/08/2026
For BMG Executive Producer of Sports Production, Graham Taylor, producing live s...
18/08/2026
TMRW Sports has appointed Rufus Hack as President of Golf, a newly created role in which he will lead the company's golf businesses including TGL presented ...
18/08/2026
SMT will provide race technology for FOX Sports' coverage of the Freedom 250 Grand Prix of Washington, D.C. on August 23, when the NTT INDYCAR SERIES races ...
18/08/2026
The live, YouTube-native roundtables combine fan voices, credentialed reporters,...
18/08/2026
Behind The Mic provides a roundup of recent news regarding on-air talent, includ...
18/08/2026
The industry legend sounds off on replacing the Heat's iconic Medusa score...
18/08/2026
William F. Rasmussen, the sports fan-turned broadcaster and entrepreneur whose out-of-the-box idea of a 24-hour cable sports network, ESPN, changed forever the ...
18/08/2026
DAZN Group has completed its acquisition of ViewLift, a provider of streaming and digital solutions for sports content owners. The acquisition was first announc...
18/08/2026
The American Association of Professional Baseball (AAPB) has added SI TV, Sports Illustrated's 24/7 streaming channel, as a broadcast partner for the remain...
18/08/2026
The Esports Foundation has announced that the inaugural Esports Nations Cup (ENC), originally scheduled for November 2026 in Riyadh, will be postponed to Novemb...
18/08/2026
Diversified has announced a new Global Managed Services Practice, consolidating the company's managed services capabilities into one organization. Rob Mello...
18/08/2026
Appear has completed a proof of concept with Thoroughbred Racing Productions (TRP), demonstrating multi-camera remote live production over bonded 5G cellular an...
18/08/2026
Riedel Communications has announced that Edith Cowan University (ECU) in Perth, ...
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
