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.
