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Over 4 many years since its discovery, human immunodeficiency virus (HIV) stays one of the crucial difficult infectious illnesses. Antiretroviral remedy (ART) has turned HIV from a deadly analysis right into a manageable situation, however lifelong every day remedy remains to be the norm for many sufferers, and a real treatment stays elusive. Nonetheless, biotech firms haven’t given up on discovering a remedy for HIV.
The biotech trade has made progress in each remedy and prevention, and heavyweights like Gilead, ViiV Healthcare, and Janssen have led the cost with single-tablet regimens, long-acting injectables like Cabenuva and Apretude, and promising improvements equivalent to capsid inhibitors and next-generation PrEP. However even with all this progress, vital gaps stay: remedy fatigue, viral reservoirs, resistance, and protracted stigma nonetheless complicate the trail ahead.
In parallel, a brand new wave of biotech firms – usually much less seen – is working to deal with HIV with recent concepts. From gene modifying and artificial antibodies to therapeutic vaccines and long-acting oral platforms, these startups might reshape the HIV panorama as soon as once more.
Listed below are a few of the most promising under-the-radar firms aiming to alter how we deal with and even treatment HIV.
AELIX Therapeutics
- Expertise: Therapeutic HIV vaccine
- Lead Asset: HTI immunogen-based vaccine
- Current Information: Acquisition of HTI vaccine belongings by Gilead Sciences in November 2024
Based in Barcelona, Spain, AELIX Therapeutics emerged as a spin-off from the HIVACAT program, a Catalan public-private consortium devoted to HIV analysis. The corporate is now growing therapeutic vaccines for HIV.
AELIX’s core expertise revolves across the HTI immunogen, designed to redirect the physique’s immune response towards essentially the most susceptible areas of the HIV virus. This goals to reinforce the immune system’s means to regulate and probably eradicate the virus by focusing on areas much less susceptible to mutation. The HTI immunogen was developed primarily based on observations that sure T-cell responses are enriched in people who exhibit higher management over HIV an infection.
The corporate’s flagship asset, the HTI vaccine, has undergone section 1 and section 2 medical trials. Outcomes indicated that the vaccine is secure and induces stable T-cell responses, contributing to improved viral management in some contributors throughout remedy interruptions.
In November 2024, Gilead Sciences acquired AELIX Therapeutics’ investigational belongings associated to the HTI vaccine. This acquisition might give a wanted push to HIV analysis, as Gilead goals to additional develop the HTI immunogen as a part of its broader technique to discover a treatment for HIV.
Excision BioTherapeutics
- Expertise: CRISPR-Cas9 gene-editing remedy
- Lead Asset: EBT-101
- Current Information: Part 1/2 trial demonstrated security and tolerability
Excision BioTherapeutics was based in 2015 and is predicated in San Francisco. The corporate is growing CRISPR-based therapies for viral infectious illnesses, together with HIV.
Excision’s proprietary strategy makes use of CRISPR-Cas9 gene-editing expertise to focus on and take away latent viral DNA embedded inside the host genome. Its lead candidate, EBT-101, employs an adeno-associated virus (AAV) supply system to introduce CRISPR-Cas9 together with twin information RNAs into the affected person’s cells. These information RNAs acknowledge and direct the Cas9 enzyme to particular websites inside the HIV genome, facilitating the excision of considerable parts of the viral DNA.
EBT-101 is presently in a section 1/2 medical trial involving people residing with HIV who’re on steady antiretroviral remedy (ART). In Could 2024, Excision reported that the trial met its major endpoint, with the candidate being typically secure and well-tolerated amongst contributors. No severe opposed occasions had been noticed, and solely gentle opposed occasions associated to the remedy had been reported, all of which resolved with out intervention.
Regardless of the favorable security profile, the trial revealed that EBT-101 didn’t preserve viral suppression when ART was discontinued. Individuals who paused their ART skilled viral rebound, indicating that whereas EBT-101 successfully targets and removes parts of the HIV genome, it could not utterly remove all viral reservoirs. These findings counsel that further methods or mixture therapies could also be needed to realize sustained viral remission.
In response, Excision is exploring larger doses of EBT-101 and various supply strategies, equivalent to lipid nanoparticles, to reinforce the remedy’s efficacy and potential for redosing. Whereas efficacy outcomes are combined in the intervening time, it’s nonetheless price following EBT-101’s progress.
HOOKIPA Pharma
- Expertise: Arenavirus-based therapeutic vaccine platform
- Lead Asset: HB-500
- Current Information: Accomplished enrollment for section 1b medical trial in January 2025
Based in 2011 and headquartered in New York and Vienna, HOOKIPA Pharma specializes within the improvement of immunotherapies. Its proprietary arenavirus platform is designed to reprogram the physique’s immune system to fight infectious illnesses and cancers.
HOOKIPA leverages genetically engineered arenaviruses to elicit antigen-specific CD8+ T cell responses. By modifying these viruses to precise disease-specific antigens, the platform goals to stimulate the immune system to acknowledge and assault contaminated or malignant cells. This expertise has been utilized to numerous therapeutic areas, together with oncology and infectious illnesses.
The corporate’s lead HIV asset, HB-500, is a therapeutic vaccine developed in collaboration with Gilead Sciences. HB-500 makes use of two replicating vectors primarily based on the arenaviruses Pichinde virus and lymphocytic choriomeningitis virus. These vectors ship HIV antigens derived from immunogenic areas of HIV-1 proteins which can be extremely conserved inside HIV-1 clade B variants. The immunogens differ by their amino acid sequences, permitting for protection of over 80% of circulating HIV-1 viral variants.
In January 2025, HOOKIPA introduced the completion of enrollment for its section 1b medical trial evaluating HB-500 for the remedy of HIV. The trial entails 30 contributors, and its major completion is anticipated within the second half of 2025.
Underneath the collaboration settlement, HOOKIPA is accountable for advancing the HIV program via the completion of the section 1b medical trial, after which Gilead has the unique proper to additional develop this system.
Immuno Treatment BioTech
- Expertise: PD-1-enhanced DNA vaccine platform
- Lead Asset: ICVAX
- Current Information: Accomplished section 1 medical trial in September 2024
Primarily based in Hong Kong Science Park, Immuno Treatment BioTech develops DNA vaccines and immunotherapies for infectious illnesses and cancers. Its proprietary PD-1-enhanced DNA vaccine platform goals to enhance immune responses by focusing on dendritic cells that provoke and regulate adaptive immunity.
The biotech’s strategy entails fusing the extracellular area of human PD-1 (programmed death-1) with HIV antigens to create a DNA vaccine that enhances antigen presentation. The result’s an amplified activation of antigen-specific CD8+ T cells, that are vital for figuring out and eliminating HIV-infected cells.
The corporate’s main HIV candidate is ICVAX, a therapeutic DNA vaccine engineered to elicit broad and polyfunctional T-cell responses towards a number of HIV-1 subtypes. Preclinical research demonstrated that ICVAX induced sturdy effector-memory T-cell responses and successfully suppressed viral replication in animal fashions.
In section 1, ICVAX was nicely tolerated, and contributors receiving the optimum dose exhibited greater than a twofold enhance in T-cell responses. Following the profitable completion of section 1, Immuno Treatment is getting ready to provoke a multi-center section 2 trial in mid-2025.
Immunocore
- Expertise: T cell receptor (TCR) bispecific immunotherapy
- Lead Asset: IMC-M113V
- Current Information: Offered preliminary a number of ascending dose knowledge at CROI 2025
Primarily based in Oxfordshire, England, Immunocore develops TCR bispecific immunotherapies. Whereas the corporate has primarily centered on oncology, it has expanded its platform to handle infectious illnesses, together with HIV.
Immunocore’s ImmTAV platform builds on T cell receptor (TCR) biology, providing a approach to detect and destroy virus-infected cells that customary antibodies can’t attain. Whereas antibodies acknowledge proteins outdoors a cell, TCRs can establish tiny viral fragments offered on the floor of contaminated cells by way of HLA molecules, basically giving the immune system a view contained in the cell.
ImmTAV molecules include a high-affinity, virus-specific TCR that binds to those viral peptides, coupled with an anti-CD3 fragment that recruits polyclonal T cells to kill the contaminated cell. In HIV, this enables for the exact focusing on and elimination of latent HIV reservoirs.
Immunocore’s HIV candidate, IMC-M113V, helps the immune system discover and destroy cells hiding the virus. It really works by focusing on a small piece of the HIV virus that’s displayed on the floor of contaminated cells – one thing the immune system doesn’t usually see. As soon as IMC-M113V binds to those contaminated cells, it brings in T cells to kill them. The purpose is to shrink the pool of contaminated cells that stay within the physique even when sufferers are on antiretroviral remedy, a serious barrier to curing HIV.
In March 2025, Immunocore offered preliminary knowledge from the a number of ascending dose portion of its section 1/2 STRIVE trial on the Convention on Retroviruses and Opportunistic Infections (CROI). The findings indicated that IMC-M113V was nicely tolerated, with no dose-limiting toxicities noticed. Moreover, there have been indicators of dose-dependent viral management following antiretroviral remedy interruption in some contributors.
Sumagen
- Expertise: Genetically modified whole-killed HIV-1 vaccine
- Lead Asset: SAV001
- Current Information: Achieved manufacturing milestone with Naobios in October 2024
Sumagen, a subsidiary of South Korean agency Curocom, is a biotech firm centered on the prevention of HIV. Primarily based in Ontario, Canada, the corporate has centered its efforts round an inactivated virus strategy to elicit a powerful immune response towards HIV.
Sumagen’s vaccine candidate, SAV001, is predicated on a genetically modified, whole-killed HIV-1 virus. By chemically inactivating the virus whereas preserving its outer construction, the vaccine goals to imitate pure HIV publicity with out the chance of an infection. The purpose is to stimulate the manufacturing of broadly neutralizing antibodies able to defending towards numerous strains of HIV.
Though SAV001 accomplished a section 1 trial again in 2013 with encouraging security and immunogenicity knowledge, this system remained largely dormant for a number of years. In 2024, nonetheless, Sumagen reignited its efforts by partnering with French CDMO Naobios to optimize the vaccine’s industrial manufacturing course of. This collaboration resulted within the profitable bench-scale manufacturing of SAV001 in October 2024 – a milestone that lays the groundwork for a long-awaited section 1/2 trial, anticipated to start in 2025.
A gradual development in a really difficult space of biotech
In 2024, the market was valued at roughly $32.8 billion and is projected to succeed in $44.5 billion by 2030, a compound annual development fee (CAGR) of 5.2%.
But, regardless of this regular development, the trail ahead stays advanced. Entry and affordability proceed to restrict the worldwide influence of medical innovation. In parallel, adherence – nonetheless a cornerstone of HIV management – stays a problem. Even with improved tolerability and easier regimens, points like remedy fatigue, stigma, and the burden of every day treatment persist, particularly amongst susceptible populations.
One other looming concern is drug resistance. As remedy protection grows, so does the necessity for sturdy surveillance and next-generation therapeutics that may keep forward of evolving viral strains. Whereas main gamers like Gilead, ViiV Healthcare, and Janssen proceed to form the usual of care, the momentum behind smaller biotech companies is constructing.
