Novel Gene Therapy and DNA Vaccine Approaches Show Promise for Functional HIV Cure
核心洞察
A gene therapy delivering a CCR5 (搜索)-blocking antibody enabled six SHIV-infected monkeys to control infection for over one year after a single injection.
Immuno Cure's therapeutic HIV DNA vaccine (搜索) showed viral control in two of seven patients in IIT extension trials, with Phase II trials planned for completion by 2028.
The DNA vaccine approach could allow HIV patients to avoid lifelong antiretroviral therapy, potentially reducing both side effects and financial burden.
A dual-track advance in the pursuit of a functional HIV cure has emerged from preclinical and clinical research, with a gene therapy approach demonstrating durable viral control in monkeys and a therapeutic DNA vaccine showing early signs of efficacy in human trials.
In a preclinical study, researchers delivered a gene encoding an antibody that blocks CCR5 (搜索) — the cell-surface receptor HIV exploits to establish infection — into monkeys infected with SHIV, a laboratory-engineered hybrid of HIV and its simian counterpart SIV. Six animals that received a single injection of the potential gene therapy have controlled their infections for more than one year, according to findings reported by the research team. The approach represents a resurgence for gene-therapy strategies against HIV, which have historically struggled to gain clinical traction.
Therapeutic DNA vaccine enters clinical evaluation
Separately, Immuno Cure BioTech Limited (搜索), headquartered in Hong Kong Science Park, announced results from its investigator-initiated trial (IIT) extension studies of a therapeutic HIV DNA vaccine (搜索) — described as the world's first nucleic acid HIV vaccine to enter clinical trials. The study, conducted at Shenzhen Third People's Hospital, enrolled 10 volunteer HIV patients, with seven completing the full treatment course.
Chen Zhiwei, co-founder of Immuno Cure and chair of Immunology & Immunotherapy and director of the AIDS Institute at HKU Med, reported that two participants achieved significant viral control, while all but one demonstrated some degree of control. "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," Chen said during an academic seminar in Shenzhen.
Addressing a persistent global health burden
According to United Nations data cited in the announcement, approximately 40.8 million people are living with HIV worldwide. Despite global commitments to keep new infections below 370,000 annually, 1.3 million new cases were recorded in 2024. Since the identification of AIDS in 1981, 44.1 million people have died from HIV-related causes.
Current standard-of-care antiretroviral therapy requires lifelong daily medication and does not cure the infection. In the United States, the list price for Biktarvy, a mainstream HIV treatment, stands at $4,216 per month — approximately $50,000 annually — underscoring the financial burden on patients and healthcare systems.
Vaccine-based strategy aims to replace lifelong medication
Unlike conventional antiretroviral drugs, nucleic acid vaccines are designed to help patients' immune systems control viral replication without continuous medication, potentially reducing long-term side effects. Immuno Cure's approach involves a series of injections administered over several years rather than daily pills.
Anthony Cheung, senior commercial manager of Immuno Cure, indicated the company hopes to price the vaccine between 10,000 yuan (approximately $1,479) and 20,000 yuan per dose. The expected full course involves roughly 10 doses over approximately three years, though Cheung noted that dosing will require adjustment based on clinical progress and individual patient conditions.
Development timeline and next steps
Immuno Cure has outlined an ambitious clinical development pathway: the company plans to complete Phase II trials by 2028 and subsequently apply for conditional approval in select hospitals. Full market launch across China, including Hong Kong, is anticipated around 2030 or 2031. In May, the company launched a technology innovation center in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Zone, focusing on HIV vaccine research, development, and application.
The IIT extension studies serve as a bridge between Phase I and Phase II trials, designed to provide stronger support for the next stage of clinical evaluation. The emerging data from both the preclinical gene therapy model and the early clinical vaccine results suggest that achieving a functional cure — where patients maintain viral suppression without ongoing antiretroviral medication — may be an increasingly tangible goal.