T Cell Vaccine Demonstrates Safety as Functional Cure for Hepatitis B Virus in Phase 1 Trial

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The first-in-human trial of VRON-0200, a novel immunotherapy for chronic hepatitis B virus, presented at the APSAL meeting, demonstrates a promising safety and tolerability profile.

Grace Wong, MD | Credit: X.com

Grace Wong, MD
Credit: X.com

Data from a first-in-human trial of a novel, first-in-class, checkpoint modifier immunotherapy called VRON-0200 suggests the agent, which is intended to be a functional cure for hepatitis B virus (HBV), was well tolerated among patients with chronic HBV infection.

Presented at the Asian Pacific Association for the Study of the Liver (APSAL) meeting, safety data from cohort 1 of the trial, which included 10 patients, suggest the well tolerated with no serious adverse events reported in the trial, no observed safety concerns, and no unexpected laboratory abnormalities, including for liver function tests.1,2

"With almost 300 million persons living with chronic hepatitis B in the world, there is a high – and critical - unmet medical need for a functional cure that is not only effective, but also safe,” said lead investigator Grace Wong, MD, from the Chinese University of Hong Kong.1 “These first clinical data suggest that VRON-0200 is safe and well tolerated, after a single injection into the arm muscle. I look forward to additional safety and other clinical data being available soon."

A clinical-stage, biotechnology company developing novel T cell-based immunotherapies, Virion Therapeutics announced the data presentation in a press release on March 27, 2024. The phase 1b trial presented at APSAL 2024 was launched following preclinical data suggesting VRON-0200 could amplify, broaden, and enhance T cell responses through checkpoint modification, which might improve viral control in chronic HBV infection.1,2

With this in mind, the trial leveraged a 2-cohort design, with cohort 1a receiving low dose prime vaccination of VRON-0200 via adenovirus vectors (AdC) of serotype 7 (AdC7) and cohort 1b receiving the agent via AdC of serotype 6. In total, 10 patients were included in the trial, with 5 in each cohort.1,2

For inclusion, patients needed to be aged 18-55 years, have a BMI of 18-32 kg/m2, and be non-cirrhotic, HBeAg positive or negative, chronic hepatitis B patients currently taking nucleos(t)ide antiviral therapy with HBV DNA less than 40 IU/mL and HBsAg less than 500 IU/mL. The 10 patients included in the trial had a median age of 44.5 (41-54) years, 100% were male, and 80% were Asian.1,2

In the analysis presented at APASL 2024, investigators had aggregated data from 641 total on-treatment prime patient safety days. Results of the safety and tolerability analyses presented at the meeting indicated there were 2 grade 1 adverse events in cohort 1b, which consisted of a leg cramp not considered to pre treatment related and flu-like symptoms considered to be treatment related. Investigators pointed out there were resolved without treatment.1,2

Further analysis suggested there were no clinically relevant abnormalities in laboratory tests, including liver function tests, electrocardiograms, or vital signs, observed in the trial. In their release, Virion Therapeutics noted plans to share additional safety data from the trial later in 2024.1

“Finding a treatment for chronic HBV-infected patients will almost assuredly require an immune-based component to help control the infection. To date, the best responses have been observed with regimens that contain pegylated interferon, which requires weekly injections and is often accompanied by high rates of adverse events,” said study investigator Sue Currie, chief operating officer of Virion.1These VRON-0200 data - the first ever for a checkpoint modifier containing T cell vaccine of any kind - represent a critical first step in Virion's mission to bring a safe, well tolerated, and easy to administer interferon-sparing functional cure immunotherapy to HBV-infected patients worldwide"

References:

  1. Virion Therapeutics. Promising first-in-human phase 1b clinical study data from VRON-0200, a novel, first-in-class checkpoint modifier immunotherapy for chronic hepatitis B virus functional cure, presented as late-breaker at 2024 APASL global liver meeting. PR Newswire: press release distribution, targeting, monitoring and marketing. March 28, 2024. Accessed March 28, 2024. https://www.prnewswire.com/news-releases/promising-first-in-human-phase-1b-clinical-study-data-from-vron-0200-a-novel-first-in-class-checkpoint-modifier-immunotherapy-for-chronic-hepatitis-b-virus-functional-cure-presented-as-late-breaker-at-2024-apasl-global-liver-me-302100640.html.
  2. Wong GL, Currie SL, Luber A, Ertl HCJ, Gane EJ. First-in-Human, First-in-Class, Phase 1B Preliminary Safety Data of VRON-0200, a Novel Checkpoint Modifier Containing Immunotherapy, for HBV Functional Cure. Paper presented at: The Asian Pacific Association for the Study of the Liver. March 27 – 31, 2024. Kyoto, Japan.
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