Virion Therapeutics Finalizes Enrollment for Phase 1b VRON-0200 HBV Trial

Virion Therapeutics, LLC, a biotechnology company based in Philadelphia, is progressing with its groundbreaking research into immunotherapies for chronic diseases, specifically targeting Chronic Hepatitis B Virus (CHB) infections. As part of its ongoing clinical efforts, the company recently completed enrollment for the first two cohorts in its Phase 1b clinical trial of VRON-0200, a new therapeutic immunotherapy designed for the functional cure of CHB.

The VRON-0200 trial has involved 27 patients with CHB, all of whom were receiving nucleos(t)ide antiviral therapy. These participants received intramuscular injections of VRON-0200, either as a single dose or with an additional booster dose. Early results from the study have been promising, indicating that the treatment is both safe and well tolerated. Moreover, VRON-0200 demonstrated the capacity to trigger immune responses and exhibit anti-HBV activity, even in patients who had severely compromised HBV immunity before treatment. A third cohort trial, which is testing VRON-0200 in combination with other investigational anti-HBV agents, has commenced.

Sue Currie, Ph.D., Chief Operating Officer of Virion and a co-author of the study, remarked on the rapid enrollment process, emphasizing that both healthcare providers and patients are eager for new, effective immunotherapies for CHB that are simple to administer, safe, and tolerable. She noted that current treatments such as pegylated interferon (Peg-IFN) present various challenges, including high rates of adverse events and prolonged treatment durations of 24-48 weeks. In contrast, VRON-0200 offers a more straightforward treatment regimen, involving one or two injections, along with a favorable safety profile. This positions VRON-0200 as a potential interferon-sparing therapy that could be used alone or in combination to achieve a functional cure for HBV, aiming to benefit nearly 300 million people worldwide living with chronic HBV.

The Phase 1b trial of VRON-0200 is being conducted as an open-label, multi-center study designed to assess the safety, tolerability, and immunological responses of the treatment. It includes dose-escalation cohorts where non-cirrhotic, HBeAg-positive or -negative, chronic hepatitis B patients on nucleos(t)ide therapy with specific HBV DNA levels are randomized to receive either a prime dose or a prime-and-boost regimen. The ongoing third cohort is exploring the combination of VRON-0200 with investigational drugs elebsiran and tobevibart.

Chronic Hepatitis B continues to be a significant global health challenge despite the availability of preventive vaccines. With 296 million people infected worldwide and 820,000 fatalities annually due to HBV-related liver issues, there remains a high unmet need for effective treatments, given that existing therapies require lifelong use to manage the virus.

Virion Therapeutics, LLC, founded in 2018, is dedicated to developing innovative T cell-based immunotherapies for cancer and chronic infectious diseases. Its proprietary genetically encoded checkpoint modifiers are designed to enhance CD8+ T cell responses. The company, leveraging technology licensed from The Wistar Institute, is not only advancing its VRON-0200 program but is also pursuing other promising projects, including its VRON-0300 oncology program.

These developments underline the potential of VRON-0200 as a transformative treatment for CHB, potentially paving the way for more accessible and manageable therapies for chronic Hepatitis B and other persistent viral infections. Virion Therapeutics looks forward to providing further updates on the VRON-0200 clinical program as they continue to explore its capabilities in the upcoming year.