malaria

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…

The U.S. FDA has awarded Orphan Drug Designation to Zydus Cadila’s malaria therapeutic, the company announced last week.

The status gives the Ahmedabad-based drugmaker eligibility for “certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval,” the press release said.

Zydus Cadila is developing the potential single-dose ZY19489 (MMV253) radical cure for P.…

A new Phase 1 trial in Mali of Sanaria’s PfSPZ malaria shot showed a three-dose regimen was well-tolerated and conferred 51% vaccine efficacy against intense natural P. falciparum transmission, according to a Lancet Infectious Diseases article published in mid-November.

The results are in line with earlier studies using the five-dose regimen, per the authors.

Japan’s Global Health Innovative Technology (GHIT) Fund will invest $6.6 million in diagnostics, drugs and vaccines development, the nonprofit announced last week.

One award will advance an ongoing Chagas disease drug development project by the Drugs for Neglected Diseases Initiative (DNDI). The five other are new projects: a TB diagnostic, a placental malaria vaccine, a malaria drug, and two separate Chagas drugs (by DNDI/Takeda and DNDI/Daiichi Sankyo).

GHIT Fund’s portfolio…

The Gates Medical Research Institute (Gates MRI) has entered into a licensing agreement with Atreca to develop a novel monoclonal antibody (mAb) for the prevention of malaria, the California-based biotech announced last week.

MAM01/ATRC-501 is an engineered version of a human mAb that’s generated following vaccination with GSK’s RTS,S shot. The mAb targets the malaria circumsporozoite protein (CSP) and has been shown to protect animals against malaria infection in multiple in vivo…

The Lancet Infectious Diseases on Tuesday published first-in-human studies on a novel antimalarial compound that Merck KGaA is developing with the Medicines for Malaria Venture (MMV). The ascending-dose and volunteer infection studies support the development of M5717—a plasmodium eukaryotic translation elongation factor 2 inhibitor—as a component of a single-dose antimalarial combination therapy or for malaria prophylaxis, the article said.

However, an accompanying comment emphasized…

Novartis and Medicines for Malaria Venture (MMV) announced last week positive Phase 2b results for their novel non-artemisinin combination antimalarial. The study tested ganaplacide with a new formulation of lumefantrine optimized for once-daily dosing.

This combination has the potential not only to clear malaria infection, including artemisinin-resistant strains, but also to block the transmission of the malaria parasite, the press release said.

GSK issued a press release Wednesday welcoming WHO’s new recommendation for widespread use of the company’s RTS,S malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high P. falciparum transmission.

The shot disappointed in a 2009-2014 trial, showing only 39% efficacy against clinical malaria. But new Phase 3 results in August demonstrated that seasonal RTS,S vaccination in combination with chemoprevention reduced uncomplicated malaria by 63% and…

The Journal of Experimental Medicine published Phase 2 results last week showing that Novartis’ enzyme-blocking cancer drug imatinib cleared malaria parasites from 100% of treated adult Vietnamese men in three days when used in combination with standard of care (piperaquine plus dihydroartemisinin).

In contrast, 33% of trial participants who received only standard of care without the imatinib supplement experienced delayed parasite clearance rates—a precursor to and an indicator of…

Mentions:

The New England Journal of Medicine published Phase 3 results last week showing that seasonal vaccination with GSK’s RTS,S/AS01e malaria vaccine in combination with chemoprevention was superior to either intervention alone in children ages 5-17 months.

The trial—conducted in Burkina Faso and Mali—tested a regimen of three doses of the vaccine (followed by two annual boosters just before the peak of the malaria transmission season) and four courses of sulfadoxine-pyrimethamine and…

Mentions: