Over four decades since the identification of the human immunodeficiency virus (HIV), the global medical community continues to grapple with its complexities. While antiretroviral therapy (ART) has transformed HIV from a fatal diagnosis to a manageable chronic condition, challenges such as lifelong medication adherence, viral reservoirs, and drug resistance persist. In 2025, a new wave of biotech companies is at the forefront of developing innovative treatments that aim to address these hurdles and inch closer to a potential cure.
AELIX Therapeutics:
Based in Barcelona, AELIX Therapeutics has developed a therapeutic vaccine centered around the HTI immunogen, designed to direct the immune response toward the most vulnerable regions of the HIV virus. Clinical trials have demonstrated the vaccine's safety and its ability to induce robust T-cell responses, contributing to improved viral control during treatment interruptions. In November 2024, Gilead Sciences acquired AELIX's investigational assets related to the HTI vaccine, signaling a significant investment in therapeutic vaccine strategies.
Excision BioTherapeutics:
San Francisco-based Excision BioTherapeutics is pioneering the use of CRISPR-Cas9 gene-editing technology to target and remove latent HIV DNA embedded within the host genome. Their lead candidate, EBT-101, employs an adeno-associated virus (AAV) delivery system to introduce CRISPR-Cas9 along with dual guide RNAs into patient cells. In a Phase 1/2 clinical trial, EBT-101 was generally safe and well-tolerated, with no serious adverse events reported. However, participants experienced viral rebound upon discontinuation of ART, indicating that while EBT-101 effectively targets portions of the HIV genome, complete elimination of viral reservoirs remains a challenge. Excision is exploring higher doses and alternative delivery methods to enhance efficacy.
HOOKIPA Pharma:
HOOKIPA Pharma, headquartered in New York and Vienna, is developing HB-500, a therapeutic vaccine utilizing genetically engineered arenaviruses to elicit antigen-specific CD8+ T cell responses. Developed in collaboration with Gilead Sciences, HB-500 aims to stimulate the immune system to recognize and attack HIV-infected cells. As of January 2025, HOOKIPA completed enrollment for its Phase 1b clinical trial evaluating HB-500, with primary completion expected in the second half of 2025. Gilead holds the exclusive right to further develop the program post-trial.
Immuno Cure BioTech:
Hong Kong-based Immuno Cure BioTech is advancing ICVAX, a therapeutic DNA vaccine that fuses the extracellular domain of human PD-1 with HIV antigens to enhance antigen presentation and amplify CD8+ T cell activation. In a Phase 1 clinical trial completed in September 2024, ICVAX was well-tolerated, with participants exhibiting more than a twofold increase in T-cell responses. The company plans to initiate a multi-center Phase 2 trial in mid-2025.
Immunocore:
UK-based Immunocore is developing IMC-M113V, a T cell receptor (TCR) bispecific immunotherapy designed to detect and destroy HIV-infected cells that standard antibodies cannot reach. In March 2025, initial data from the multiple ascending dose portion of its Phase 1/2 STRIVE trial indicated that IMC-M113V was well-tolerated, with no dose-limiting toxicities observed. Some participants exhibited delayed viral rebound and maintained viral control during ART interruption, suggesting potential for reducing latent HIV reservoirs.
Sumagen:
Canadian biotech firm Sumagen is focusing on SAV001, a genetically modified, whole-killed HIV-1 vaccine designed to elicit a strong immune response without the risk of infection. After a period of dormancy, the program was revitalized through a partnership with French CDMO Naobios, leading to successful bench-scale production in October 2024. A Phase 1/2 trial is expected to begin in 2025.
These six companies exemplify the innovative efforts underway to transform HIV treatment. Their diverse approaches—ranging from gene editing and therapeutic vaccines to novel immunotherapies—highlight the multifaceted strategies being employed to tackle the persistent challenges of HIV infection. As these programs progress through clinical trials, they hold the potential to redefine the future landscape of HIV therapy.
Source:https://www.labiotech.eu/best-biotech/hiv-companies/
This is non-financial/medical advice and made using AI so could be wrong.