Ascletis has commenced its Phase II trial in China for its candidate drug ASC22 alongside anti-retroviral therapy for the functional cure and immune restoration of HIV-1 infection.
Hong Kong-based biotechnology firm Ascletis has commenced a Phase II trial in China for its candidate drug ASC22 (envafolimab) in combination with antiretroviral therapy (ART), which it is developing for the functional cure and immune restoration of human immunodeficiency virus 1 (HIV-1) infection.
ASC22 is being studied alongside ART with the goal of restoring virus-specific immune responses in people living with chronic viral infection. Aside from potentially curing HIV-1, the drug is also being tested as a possible functional cure for chronic hepatitis B.
In the Phase II multi-center trial, participants will receive 1 mg/kg or 2.5 mg/kg or a placebo plus ART therapy once a month over a 12-week treatment phase and then a 12-week follow-up period. Subjects will receive the drug via subcutaneous injection. In the placebo group, ASC22 will be replaced by 0.9% saline. Primary outcome measures are changes in CD4 and CD8 ratios from baseline at weeks four, eight and 12.
ART therapy has proven to be effective in delaying disease progression and suppressing HIV replication. However, it is not curative. ART cannot remove the HIV reservoir, and all infected individuals experience viral rebounds within weeks or a few months after the therapy is stopped. ASC22 is designed to boost the immune system against HIV-1 to enhance the body’s ability to clear the reservoir.
“This study is conducive to further exploring the possibility of clearing [the] HIV reservoir to achieve the functional cure of HIV/AIDS. We expect to generate more evidence to support this immune-based strategy and benefit more people,” Professor Fu-Sheng Wang, M.D., Ph.D., principal investigator of the Phase II trial and director of the department of infectious diseases at Fifth Medical Center of the Chinese PLA General Hospital, said.
World Health Organization 2020 data logs 37.7 million people living with HIV worldwide, and in the same year, the disease saw 1.5 million new cases and 680,000 deaths. The African region remains most hit by the virus, with one in every 25 adults (ages 15 and up) living with HIV, which translates to around two-thirds of the global case numbers. ART remains the therapy of choice, but only approximately 73% have access to it.
The Phase II trial of ASC22 “marks a new milestone that Ascletis has achieved in developing therapy for (a) functional cure of HIV/AIDS, which is still a challenge in China and globally despite the improved access of standard ART treatment,” Dr. Jinzi J. Wu, founder, chairman and chief executive officer of Ascletis commented. “By blocking [the] PD-1/PD-L1 pathway, ASC22 is expected to potentially restore HIV-1 specific immunity and clear the latent HIV reservoir.”
Ascletis joins the roster of biotech companies looking to finally cure HIV infection. In February, ImmunityBio announced promising results from the clinical study of its IL-15 superagonist Anktiva for those living with HIV. In March, Moderna dosed the first participant in a Phase I trial for a possible HIV trimer mRNA vaccine. In the same month, the U.S. Food and Drug Administration rejected Gilead Sciences’ attempt at a New Drug Application for lenacapavir, which is being proposed for the treatment of HIV-1.
There remains no cure for HIV as of this writing.
