A key step toward a functional cure for HIV patients has been achieved, as a Hong Kong biotech company’s therapeutic nucleic acid HIV vaccine — the world’s first of it kind to enter clinical trials— delivered inspiring results from its new clinical trials.
This innovative therapy holds the promise of enabling about 40 million people living with HIV worldwide to avoid lifelong medication, through vaccine injections administered over a few years to help control the virus.
During an academic seminar in Shenzhen on Tuesday, Immuno Cure BioTech Limited — headquartered in Hong Kong Science Park — announced the results of its latest IIT clinical trials of its therapeutic HIV DNA vaccine. IIT trials are extension studies based on Phase I trials, designed to provide stronger support for Phase II trials.
The study, carried out in Shenzhen Third People’s Hospital among 10 volunteer HIV patients, with seven completing the treatment, found that two achieved significant viral control while all but one showed some degree of control, marking an important milestone for HIV patients, said Chen Zhiwei, co-founder of Immuno Cure.
Chen, who is also the chair of Immunology & Immunotherapy and director of AIDS Institute at HKU Med, added that “these results, with one case showing excellent outcomes and another showing notable effects, will significantly guide the design of subsequent phase II clinical trials, particularly influencing protocol design, dosage, and treatment monitoring”.
Immuno Cure revealed that it plans to complete the second phase of clinical trials in 2028 and apply for conditional approval in select hospitals. It expects full launch of the therapy across the nation, including Hong Kong, around 2030 or 2031.
According to United Nations data, 40.8 million people are living with HIV worldwide. Although global leaders pledge to keep new cases below 370,000 per year, 1.3 million new infections were recorded in 2024. Since AIDS was discovered in 1981, 44.1 million people have died from HIV infection.
Compared to traditional antiretroviral therapy treatments, nucleic acid vaccines can help patients’ immune system control viral replication without continuous medication, reducing side effects.
The vaccines are also expected to alleviate the financial burden on people living with HIV. Currently, mainstream antiretroviral drugs on the market cannot cure HIV and require lifelong medication.
In the United States, the list price for Biktarvy, a mainstream HIV treatment drug, is $4,216 per month, which adds up to around $50,000 per year.
Anthony Cheung, senior commercial manager of Immuno Cure, said the company hopes to price the vaccine between 10,000 ($1,479) and 20,000 yuan per dose.
He added that the expected full course involves 10 doses over roughly three years, but the dosage will need to be adjusted based on clinical progress and the patient's condition.
In May, Immuno Cure launched its technology innovation center in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Zone, with a primary focus on the research, development, and application of HIV vaccines.
Davis Xu, Chen Hong contributed to this story.
