Most of the buzz on Gilead Sciences (NASDAQ: GILD) in recent months has focused on its antiviral drug remdesivir. This is understandable, given that the drug is currently the most promising therapy targeting COVID-19.
Gilead also made headlines last week after reports surfaced about the large pharmaceutical company. AstraZeneca has been interested in acquiring biotechnology. The possibility of a deal, however, seems to have evaporated by now.
But while these are the stories that have kept Gilead at the forefront of investor attention for the time being, there is another that could be a game-changer for biotech in the not-so-distant future. Could Gilead Sciences have a cure for HIV pending?
Several shots on goal
Gilead’s long-standing goal is to develop a cure for HIV. And now, biotechnology doesn’t have just one candidate in clinical trials that could achieve that goal – it has four.
In January, Gilead authorized a portfolio of Widely Neutralizing Antibodies (bNAbs) developed by Rockefeller University. Two of these bNAbs, GS-5423 and GS-2872, are being evaluated in a phase 2 trial to treat, prevent and potentially cure HIV. However, Gilead is not conducting the clinical studies alone but is working with Rockefeller.
The big biotech is also evaluating two other potential remedies for HIV in phase 1 clinical studies. Elipovimab (GS-9722) is a first-class bNAb for the targeted elimination of HIV-infected cells. Vesatolimod (GS-9620) is a Toll-like receptor 7 (TLR7) agonist that has demonstrated its potential to cure HIV-infected rhesus monkeys in preclinical testing.
Gilead presented the results of a Phase 1b study of vesatolimod in March. The drug got only a modest increase in the time to recurrence of HIV (known as viral rebound) compared to placebo, which didn’t come close to being a cure.
However, as with the development of effective HIV treatments, there is probably a greater possibility that combined approaches offer the best chance of curing HIV. Gilead executive Diana Brainard said research with vesatolimod “is deepening collective scientific knowledge on potential pathways to achieving a ‘working cure'” for HIV.
The company has even more potential components for a combination approach to cure HIV. Gilead’s latest investor presentation listed two candidate programs for curing HIV in preclinical testing – a vaccine developed in collaboration with Hookipa Pharmacy and GS-9723. Gilead has previously sought FDA approval to begin a Phase 1 clinical study for GS-9723.
Expertise that matters
Granted, it’s still early days for Gilead’s efforts to develop a cure for HIV. However, if there is one company that could be successful, it is Gilead Sciences.
Gilead’s first FDA approval was for Vistide for the treatment of AIDS patients with cytomegalovirus retinitis, an inflammatory eye disease. Over the years, Gilead has become a heavyweight in the treatment of HIV with blockbusters such as Atripla, Stribild and Truvada.
More recently, the company’s new class of anti-HIV drugs have taken over the market. Biktarvy appears to be on its way to becoming the best-selling anti-HIV drug to date. The biotechnology pipeline includes a promising long-acting HIV treatment, lenacapavir (GS-6207), which may experience even greater commercial success than Biktarvy.
Put simply, Gilead arguably knows the science of HIV better than any other drugmaker on the planet. This does not mean that the company will necessarily develop a cure for HIV on its own. Gilead’s antiviral expertise enables it to recognize the potential of other research programs (and to seek to acquire or license these programs).
This is exactly what happened in 2011. Gilead acquired Pharmasset for $ 11 billion in a deal widely criticized at the time. But this acquisition led Gilead to launch several hepatitis C treatments, which allowed the company to increase its initial investment fivefold.
The future> the present
Some investors might view Gilead’s admittedly less than impressive growth at the moment and conclude that they should pass up the biotechnology stocks. I think this view is shortsighted. When investing, the future is always more important than the present.
Gilead will almost certainly be have a strong winner with remdesivir. He is awaiting FDA approval for filgotinib, which has the potential to become the company’s first blockbuster in immunology. Biotechnology is building its oncology pipeline through acquisitions and partnerships. And, yes, Gilead’s future in HIV is very bright. It won’t be surprising that the big buzz for the company in a few years has nothing to do with COVID-19 and everything to do with a long sought-after cure for HIV.
This article represents the opinion of the author, who may disagree with the “official” recommendation position of a premium Motley Fool consulting service. We are heterogeneous! Challenging an investment thesis – even one of our own – helps us all to think critically about investing and make decisions that help us become smarter, happier, and richer.