Gilead announces licensing agreement for Rockefeller University bNAbs

On 9 January 2020, Gilead Sciences announced that the company had signed an exclusive global licensing agreement for broadly neutralising monoclonal antibodies (bNAbs) that are in development at Rockefeller University in New York.

Gilead is the most important developer of HIV drugs over the last 20 years, and the company has consistently out-performed larger and more established research-based companies. The income from their HIV drugs – together with sharp scientific foresight – enabled Gilead to acquire sofosbuvir for hepatitis C. Not only was sofosbuvir dramatically more effective than previous treatment (producing cure rates well-above 90% from a three month course of oral treatment) but the controversial decision to price sofosbuvir so high in Western countries ensured that their $11 billion investment was recovered many times over.

bNAbs are developed from individuals who develop strong immune responses, and work both from a direct antiretroviral effect and an immune-mediated response.

Although it is always expected that newer and better bNAbs will continue to be discovered, the two lead compounds at Rockefeller University – BNC117 and 10-1074 – are already amongst the best. Importantly, as with other HIV treatments, these immune-based treatments need to be used in combinations, so acquiring several bNAbs in the same license will put Gilead well ahead of other competitors in this field.

The press release notes that the Rockefeller University’s bNAbs are “well studied and have shown exceptional promise in early clinical trials”. Even though still in early stages of development this promise is certainly true. Both compounds have already been developed into long-acting formulations that might allow six-monthly dosing. Current studies involve stopping HIV oral treatment, with the expectation that viral load might be maintained at undetectable levels solely from the extended action of the bNAbs.

Although the early data is still very limited and preliminary, this outcome would have the potential to change the approach to HIV treatment that is at least as significant as sofosbuvir had for hepatitis C.

comment

HIV research into bNAbs is some of the most exciting – with a role both for HIV prevention and HIV treatment – and with a potential role in development of an HIV cure. So this announcement is good news because taking their development to a new level requires the investment that Gilead can bring – and the company is already active in HIV cure-related research.

But if proven effective, cost and access will be an essential issue. Although in low incidence indications for cancer treatment they are often priced at higher than US$100,000 per treatment, bNAbs also have the potential to be affordably manufactured and priced – perhaps well below US$500.

The emphasis on Gilead having exclusive global rights might be encouraging for any eventual access in low income countries as generic versions of their other HIV drugs are available through the Medicines Patent Pool. However, if the results prove to be good access in middle- and high-income countries will also need to be at affordable prices that is very different to that used for sofosbuvir.

The press release did not include any financial details about the agreement.

A UK study with long versions of BNC117 and 10-1074 called RIO is expected to begin enrolment early in 2020.