Vesatolimod

The companies have not disclosed the value of the asset acquisition. Credit: PeopleImages.com – Yuri A via Shutterstock. Gilead Sciences has bolstered its position as a leader in the HIV research space by purchasing an investigational HIV vaccine from Spanish biotech Aelix Therapeutics. The companies first linked up in 2018 to investigate Aelix’s vaccine with Gilead’s antiviral vesatolimod in HIV-infected individuals. Now, Gilead will inherit a recombinant vector vaccine that comprises an HIVACAT T cell immunogen (HTI). The HTI vaccine has been evaluated in Phase I and Phase II clinical trials. In February 2023, Aelix presented positive data from the Phase II AELIX-003 trial (NCT04364035), announcing that the study met its primary and secondary endpoints for safety, tolerability, and immunogenicity. The trial evaluated the vaccine in combination with vesatolimod in people with HIV on antiretroviral therapy. The company’s vaccine is based on a T cell vaccine immunogen design that directs the body’s immune defense to the most vulnerable parts of the HIV virus. Aelix is a spin-off of HIVACAT, a Catalan public-private consortium conducting research in the field of HIV and AIDS. Gilead is considered one of the leading global companies in the HIV and AIDS research space. The company already has several HIV treatments under its belt, including Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) and Descovy (emtricitabine/tenofovir). These drugs pulled in $13.8bn in sales for Gilead in 2023, a 6% increase on the previous year as per the company’s financials. In December 2022, the US Food and Drug Administration granted approval to Gilead’s Sunlenca (lenacapavir) as an HIV treatment for patients resistant to other medication options. The active ingredient in Sunlenca – lenacapavir – is also being investigated in the PURPOSE-1 (NCT04994509) and 2 clinical trials as a PrEP medication, a group of drugs that HIV-negative people can take to minimise the risk of contracting HIV. The investigational twice-yearly injectable hit the headlines earlier this year, demonstrating a 100% efficacy in the PURPOSE-1 trial, which evaluated PrEP lenacapavir versus alternative daily PrEP in 5,345 HIV-negative, adolescent girls and young women aged 16 to 26 in South Africa and Uganda. Gilead plans to use the data from both PURPOSE trials to support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024. In May 2024, public figures, scientists, medical professionals, and celebrities wrote an open letter to Gilead, urging them to provide fair access to HIV drugs in low- and middle-income countries (LMICs). In October 2024, Gilead Sciences announced the signing of voluntary licensing agreements with six generic pharmaceutical manufacturers to facilitate access to lenacapavir in 120 resource-limited and high-incidence nations.

Long known for its HIV drugs, Gilead is further delving into the field by acquiring investigational vaccines for the stubborn virus from a little-known biotech in Spain. Gilead is paying an undisclosed amount to buy HTI T cell immunogen HIV vaccines from Barcelona-based Aelix Therapeutics, a spinout from a Catalan public-private program created to find a vaccine for the virus. The companies declined to disclose deal terms. In the HIV epidemic’s 40-plus-year history, a vaccine has never made it across the regulatory finish line, continuously puzzling researchers and drugmakers. Many treatments exist, as do effective preventative measures like PrEP, but a vaccine remains elusive as HIV can stealthily hide from the immune system in reservoirs. Johnson & Johnson suffered two mid- and late-stage failures in 2021 and 2023 . Gilead is getting its hands on experimental HIV vaccine assets from Aelix, which has taken a regimen through Phase 2a. The startup tested its T cell vaccines ChAdOx1.HTI and MVA.HTI along with Gilead’s toll-like receptor agonist, known as vesatolimod, in people with HIV who were taking antiretroviral therapy, or ART. The Phase 2a study , dubbed AELIX-003, wrapped up in late 2022. Researchers said the regimen was “safe and well tolerated” with “high levels of HTI-specific T-cell responses,” according to a presentation at the Conference on Retroviruses and Opportunistic Infections in February 2023. Further, 10 of 30 AELIX-003 participants on the vaccine-vesatolimod regimen were able to stay off ART for 24 weeks. In the placebo group, four of 17 participants were able to do so, according to a press release . “The HTI vaccines have shown promising results in Phase 1 and Phase 2 clinical trials, and we are eager to see this immunogen move forward through this acquisition and potentially become an important aspect of the search for an HIV cure,” Aelix chair Thomas Hecht said in a Monday statement . The epidemic is still far-reaching, and a vaccine is seen as a critical way to finally bring it to an end. About 39.9 million people lived with HIV at the end of 2023, a year in which another 1.3 million new cases were reported. About 630,000 people died last year from HIV-related causes, according to the World Health Organization. HIV drugs are a core part of Gilead’s portfolio. Its HIV medicines, including Biktarvy and Descovy, made $5.1 billion in the third quarter, or about 68% of the company’s total sales in that period. But advocates have called for greater access to the drugmaker’s treatments and PrEP medicines, which they say are too costly and not readily available. The California biopharma made international headlines earlier this year when it said its twice-a-year injection of lenacapavir fully prevented HIV in cisgender women. The shot succeeded in another pivotal trial in September. Gilead is also working on multiple other programs, including long-acting oral inhibitors and injectables, a bispecific T cell engager and a once-weekly pill. The pill, a combination of lenacapavir and Merck’s islatravir, is entering two Phase 3 trials, the companies said last month. Gilead can also opt into programs from Gritstone bio and Hookipa Pharma. Aelix derives from HIVACAT, a Catalan program focused on HIV vaccines involving the IrsiCaixa AIDS Research Institute and Hospital Clínic de Barcelona. Ysios Capital and 10K Lakes Capital, among others, have backed Aelix.