Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir. The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral…
GSK to invest £1 billion on infectious disease research
GSK plc (NYSE:GSK) has announced its plans to spend £1 billion over the next ten years on R&D focused on infectious diseases that disproportionately affect lower-income countries. Diseases covered in the research will include malaria, tuberculosis, HIV, neglected tropical diseases (NTDs) and antimicrobial resistance (AMR). The HIV focus will be through ViiV Healthcare, a joint…
Moderna says its mRNA Access program could help with the next pandemic
Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…
NIH to launch clinical trial of three mRNA HIV vaccines
The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences. The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. The three HIV vaccine…
Biktarvy shows high efficacy at five years in treatment-naïve adults with HIV
Gilead Sciences (NSDQ:GILD) announced that Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) offered sustained efficacy at week 240 in two Phase studies (Study 1489 and Study 1490). The Foster City, California–based company noted that there were no cases of treatment failure as a result of viral resistance detected in the studies. The…
How Vir Biotechnology intends to functionally cure HIV and prevent malaria
Vir Biotechnology (NSDQ:VIR) with its partner GSK (LSE/NYSE:GSK) recently announced growing traction for the investigational COVID-19 monoclonal antibody sotrovimab. Now, San Francisco–based Vir has expanded its partnership with the Bill & Melinda Gates Foundation to focus on developing broadly neutralizing antibodies intended to provide a “vaccinal effect” for treating HIV and preventing malaria. Vir Biotechnology…
7 potential applications of mRNA-based therapies
Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…
Antivirals could be a vital weapon in the COVID-19 pandemic endgame
Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could…
J&J says study found its investigational HIV vaccine didn’t provide enough protection
Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection. New Brunswick, N.J.–based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young…
Gilead’s lenacapavir shows promise for multi-drug-resistant HIV
Gilead Sciences presented new results from its Phase 2/3 CAPELLA study focused on its investigational, long-acting HIV-1 capsid inhibitor, lenacapavir. The trial, which involved heavily treatment-experienced people with multi-drug resistant HIV-1 infection, showed that lenacapavir had substantial virologic suppression for 26 weeks. In November, the company had announced that 88% of lenacapavir recipients in the…
Merck moving to Phase 2 study of drug-eluting implant to prevent HIV infection
Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Get the full story at our sister site, Drug Delivery Business News.
Abbott researchers help discover a clue to an HIV cure
Abbott announced today that a team including its scientists has uncovered a rare group of Democratic Republic of Congo residents who are HIV positive but have almost nonexistent viral loads without using antiretroviral treatments. This group of “HIV elite controllers” opens up a new area for researchers to discover biological trends that could inform the…