HIV innovation: Six companies developing new treatments in 2025

Over four decades since its discovery, human immunodeficiency virus (HIV) remains one of the most challenging infectious diseases. Antiretroviral therapy (ART) has turned HIV from a fatal diagnosis into a manageable condition, but lifelong daily treatment is still the norm for most patients, and a true cure remains elusive. However, biotech companies have not given up on finding a treatment for HIV.

The biotech industry has made progress in both treatment and prevention, and heavyweights like Gilead, ViiV Healthcare, and Janssen have led the charge with single-tablet regimens, long-acting injectables like Cabenuva and Apretude, and promising innovations such as capsid inhibitors and next-generation PrEP. But even with all this progress, significant gaps remain: treatment fatigue, viral reservoirs, resistance, and persistent stigma still complicate the path forward.

In parallel, a new wave of biotech companies – often less visible – is working to tackle HIV with fresh ideas. From gene editing and synthetic antibodies to therapeutic vaccines and long-acting oral platforms, these startups could reshape the HIV landscape once again.

Here are some of the most promising under-the-radar companies aiming to change how we treat or even cure HIV.

​AELIX Therapeutics​

• Technology: Therapeutic HIV vaccine
• Lead Asset: HTI immunogen-based vaccine
• Recent News: Acquisition of HTI vaccine assets by Gilead Sciences in November 2024

Founded in Barcelona, Spain, AELIX Therapeutics emerged as a spin-off from the HIVACAT program, a Catalan public-private consortium dedicated to HIV research. The company is now developing therapeutic vaccines for HIV.​

AELIX’s core technology revolves around the HTI immunogen, designed to redirect the body’s immune response toward the most vulnerable regions of the HIV virus. This aims to enhance the immune system’s ability to control and potentially eradicate the virus by targeting areas less prone to mutation. The HTI immunogen was developed based on observations that certain T-cell responses are enriched in individuals who exhibit better control over HIV infection. ​

The company’s flagship asset, the HTI vaccine, has undergone phase 1 and phase 2 clinical trials. Results indicated that the vaccine is safe and induces solid T-cell responses, contributing to improved viral control in some participants during treatment interruptions. ​

In November 2024, Gilead Sciences acquired AELIX Therapeutics’ investigational assets related to the HTI vaccine. This acquisition could give a needed push to HIV research, as Gilead aims to further develop the HTI immunogen as part of its broader strategy to find a cure for HIV. 

Excision BioTherapeutics

• Technology: CRISPR-Cas9 gene-editing therapy
• Lead Asset: EBT-101
• Recent News: Phase 1/2 trial demonstrated safety and tolerability

Excision BioTherapeutics was founded in 2015 and is based in San Francisco. The company is developing CRISPR-based therapies for viral infectious diseases, including HIV. 

Excision’s proprietary approach utilizes CRISPR-Cas9 gene-editing technology to target and remove latent viral DNA embedded within the host genome. Its lead candidate, EBT-101, employs an adeno-associated virus (AAV) delivery system to introduce CRISPR-Cas9 along with dual guide RNAs into the patient’s cells. These guide RNAs recognize and direct the Cas9 enzyme to specific sites within the HIV genome, facilitating the excision of substantial portions of the viral DNA. 

EBT-101 is currently in a phase 1/2 clinical trial involving individuals living with HIV who are on stable antiretroviral therapy (ART). In May 2024, Excision reported that the trial met its primary endpoint, with the candidate being generally safe and well-tolerated among participants. No serious adverse events were observed, and only mild adverse events related to the therapy were reported, all of which resolved without intervention.

Despite the favorable safety profile, the trial revealed that EBT-101 did not maintain viral suppression when ART was discontinued. Participants who paused their ART experienced viral rebound, indicating that while EBT-101 effectively targets and removes portions of the HIV genome, it may not completely eliminate all viral reservoirs. These findings suggest that additional strategies or combination therapies may be necessary to achieve sustained viral remission. ​

In response, Excision is exploring higher doses of EBT-101 and alternative delivery methods, such as lipid nanoparticles, to enhance the therapy’s efficacy and potential for redosing. While efficacy results are mixed at the moment, it is still worth following EBT-101’s progress.

HOOKIPA Pharma

• Technology: Arenavirus-based therapeutic vaccine platform
• Lead Asset: HB-500
• Recent News: Completed enrollment for phase 1b clinical trial in January 2025

Founded in 2011 and headquartered in New York and Vienna, HOOKIPA Pharma specializes in the development of immunotherapies. Its proprietary arenavirus platform is designed to reprogram the body’s immune system to combat infectious diseases and cancers.

HOOKIPA leverages genetically engineered arenaviruses to elicit antigen-specific CD8+ T cell responses. By modifying these viruses to express disease-specific antigens, the platform aims to stimulate the immune system to recognize and attack infected or malignant cells. This technology has been applied to various therapeutic areas, including oncology and infectious diseases.

The company’s lead HIV asset, HB-500, is a therapeutic vaccine developed in collaboration with Gilead Sciences. HB-500 utilizes two replicating vectors based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus. These vectors deliver HIV antigens derived from immunogenic regions of HIV-1 proteins that are highly conserved within HIV-1 clade B variants. The immunogens differ by their amino acid sequences, allowing for coverage of over 80% of circulating HIV-1 viral variants. ​

In January 2025, HOOKIPA announced the completion of enrollment for its phase 1b clinical trial evaluating HB-500 for the treatment of HIV. The trial involves 30 participants, and its primary completion is expected in the second half of 2025. ​

Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of the phase 1b clinical trial, after which Gilead has the exclusive right to further develop the program. 

Immuno Cure BioTech

• Technology: PD-1-enhanced DNA vaccine platform
• Lead Asset: ICVAX
• Recent News: Completed phase 1 clinical trial in September 2024

Based in Hong Kong Science Park, Immuno Cure BioTech develops DNA vaccines and immunotherapies for infectious diseases and cancers. Its proprietary PD-1-enhanced DNA vaccine platform aims to improve immune responses by targeting dendritic cells that initiate and regulate adaptive immunity.

The biotech’s approach involves fusing the extracellular domain of human PD-1 (programmed death-1) with HIV antigens to create a DNA vaccine that enhances antigen presentation. The result is an amplified activation of antigen-specific CD8+ T cells, which are important for identifying and eliminating HIV-infected cells.

The company’s leading HIV candidate is ICVAX, a therapeutic DNA vaccine engineered to elicit broad and polyfunctional T-cell responses against multiple HIV-1 subtypes. Preclinical studies demonstrated that ICVAX induced strong effector-memory T-cell responses and effectively suppressed viral replication in animal models. ​

In phase 1, ICVAX was well tolerated, and participants receiving the optimal dose exhibited more than a twofold increase in T-cell responses. Following the successful completion of phase 1, Immuno Cure is preparing to initiate a multi-center phase 2 trial in mid-2025.

Immunocore

• Technology: T cell receptor (TCR) bispecific immunotherapy
• Lead Asset: IMC-M113V
• Recent News: Presented initial multiple ascending dose data at CROI 2025

Based in Oxfordshire, England, Immunocore develops TCR bispecific immunotherapies. While the company has primarily focused on oncology, it has expanded its platform to address infectious diseases, including HIV.

Immunocore’s ImmTAV platform builds on T cell receptor (TCR) biology, offering a way to detect and destroy virus-infected cells that standard antibodies can’t reach. While antibodies recognize proteins outside a cell, TCRs can identify tiny viral fragments presented on the surface of infected cells via HLA molecules, essentially giving the immune system a view inside the cell.

ImmTAV molecules contain a high-affinity, virus-specific TCR that binds to these viral peptides, coupled with an anti-CD3 fragment that recruits polyclonal T cells to kill the infected cell. In HIV, this allows for the precise targeting and elimination of latent HIV reservoirs.

Immunocore’s HIV candidate, IMC-M113V, helps the immune system find and destroy cells hiding the virus. It works by targeting a small piece of the HIV virus that’s displayed on the surface of infected cells – something the immune system doesn’t normally see. Once IMC-M113V binds to these infected cells, it brings in T cells to kill them. The goal is to shrink the pool of infected cells that remain in the body even when patients are on antiretroviral therapy, a major barrier to curing HIV.

In March 2025, Immunocore presented initial data from the multiple ascending dose portion of its phase 1/2 STRIVE trial at the Conference on Retroviruses and Opportunistic Infections (CROI). The findings indicated that IMC-M113V was well tolerated, with no dose-limiting toxicities observed. Additionally, there were signals of dose-dependent viral control following antiretroviral treatment interruption in some participants. 

Sumagen

• Technology: Genetically modified whole-killed HIV-1 vaccine
• Lead Asset: SAV001
• Recent News: Achieved production milestone with Naobios in October 2024

Sumagen, a subsidiary of South Korean firm Curocom, is a biotech company focused on the prevention of HIV. Based in Ontario, Canada, the company has centered its efforts around an inactivated virus approach to elicit a strong immune response against HIV.

Sumagen’s vaccine candidate, SAV001, is based on a genetically modified, whole-killed HIV-1 virus. By chemically inactivating the virus while preserving its outer structure, the vaccine aims to mimic natural HIV exposure without the risk of infection. The goal is to stimulate the production of broadly neutralizing antibodies capable of protecting against diverse strains of HIV.

Although SAV001 completed a phase 1 trial back in 2013 with encouraging safety and immunogenicity data, the program remained largely dormant for several years. In 2024, however, Sumagen reignited its efforts by partnering with French CDMO Naobios to optimize the vaccine’s industrial production process. This collaboration resulted in the successful bench-scale production of SAV001 in October 2024 – a milestone that lays the groundwork for a long-awaited phase 1/2 trial, expected to begin in 2025.

A steady growth in a very challenging area of biotech

In 2024, the market was valued at approximately $32.8 billion and is projected to reach $44.5 billion by 2030, a compound annual growth rate (CAGR) of 5.2%.

Yet, despite this steady growth, the path forward remains complex. Access and affordability continue to limit the global impact of medical innovation. In parallel, adherence – still a cornerstone of HIV control – remains a challenge. Even with improved tolerability and simpler regimens, issues like treatment fatigue, stigma, and the burden of daily medication persist, especially among vulnerable populations.

Another looming concern is drug resistance. As treatment coverage grows, so does the need for robust surveillance and next-generation therapeutics that can stay ahead of evolving viral strains. While major players like Gilead, ViiV Healthcare, and Janssen continue to shape the standard of care, the momentum behind smaller biotech firms is building.