HIV

Vir Biotechnology announced last week that the Gates Foundation is giving the San Francisco-based biotech $10 million in grant funding and a $40 million equity investment to back the development of platform technologies that can produce broadly neutralizing antibodies to treat HIV and prevent malaria.

The new initiative will trial the “potential impact of broadly neutralizing antibodies engineered to inhibit viral replication and spread in people infected with HIV, as well as their…

ViiV has won U.S. FDA approval for Apretude, the first long-acting injectable for pre-exposure prophylaxis of HIV, the GSK subsidiary announced Monday.

The cabotegravir-based shot can be administered as few as six times per year after the first two 600-mg doses, per the press release. In clinical trials, Apretude offered 69%-90% lower incidences of HIV when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets.

The FDA nod gives the injectable…

Mentions:

Merck has halted development of its MK-8507 investigational HIV drug after seeing a decrease in certain white blood cells in Phase 2 participants who took the non-nucleoside reverse transcriptase inhibitor in combination with islatravir, another Merck HIV drug candidate, the company announced in November.

A press release said Merck “remains confident in islatravir’s overall profile” and will continue development of the nucleoside drug. However, out of an “abundance of caution,” Merck…

Public agencies in over 100 LMICs will be able to buy SD Biosensor’s STANDARD Q HIV/Syphilis Combo test for less than $1 through a collaboration between the company, the Clinton Health Access Initiative (CHAI) and Britain’s MedAccess, the partners announced Monday.

A volume guarantee agreement between MedAccess and the South Korean manufacturer will make the WHO-prequalified diagnostic available to a cohort of countries bearing 98% of the global burden of congenital syphilis and 93% of…

Gilead’s once-daily single-tablet Biktarvy regimen (bictegravir, emtricitabine and tenofovir alafenamide) showed high effectiveness and high levels of adherence in interim results from an ongoing “real-world” study, the California-based company announced last week at the 18th European AIDS Conference.

Conducted at sites in Canada, Europe and Israel, the BICSTaR study in adults living with HIV found that 97% of treatment-naïve participants and 96% of treatment-experienced participants…

Germany’s Evotec will collaborate with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) to develop CAP256, a broadly neutralizing antibody against HIV, according to a Monday announcement from the Kenup Foundation, which brokered the deal.

The antibody—the result of a collaboration with the U.S. National Institutes of Health’s Vaccine Research Center (VRC)—demonstrated a “good safety profile” in Phase 1, per the press release, but is challenging to manufacture.…

Mentions:

Merck’s investigational HIV drug islatravir succeeded as part of a daily oral combination in two Phase 3 trials and has entered Phase 2 as part of a weekly regimen, the company announced this week.

In the Phase 3 studies, virologically suppressed adults with HIV-1 switched from other regimens to islatravir (a nucleoside reverse transcriptase translocation inhibitor) in combination with Merck’s Pifeltro (doravirine). At 48 weeks, those trials met their efficacy endpoints of the…

GSK subsidiary ViiV announced Tuesday that it will pay Shionogi nearly $27 million upfront (plus royalties and $20 million in milestones) for rights to the Osaka-based drugmaker’s S-365598 third-generation investigational integrase strand transfer inhibitor (INSTI) for potential use in ultra-long-acting HIV regimens (dosing intervals of three months or longer).

Preliminary data has shown that S-365598 “has a high genetic barrier and a resistance profile that is distinct from that of…

Mentions:

The Clinton Health Access Initiative (CHAI), Hyderabad-based Laurus Labs and Unitaid announced a deal Monday to accelerate the development, commercialization and registration of a generic version of J&J/Janssen’s fixed-dose combination HIV treatment darunavir/ritonavir (DRV/r) for children.

Laurus Labs gets a “financial incentive” for a portion of the development and commercialization costs for the second- and third-line treatment, the joint press release said, without giving…

J&J announced Tuesday that it will discontinue the Imbokodo Phase 2b trial of its Janssen subsidiary’s HVTN 705/HPX2008 HIV-1 vaccine after a primary analysis showed that the regimen failed to provide “sufficient protection” against infection in women at high risk of acquiring HIV.

The investigational mosaic-based shot—tested in women ages 18-35 in five sub-Saharan African countries, with four doses given over one year—demonstrated only 25% efficacy two years after the first dose,…

Mentions: