ImmunityBio launched a Phase 1 trial last week to evaluate whether its interleukin-15 (IL-15) superagonist Anktiva (N-803), used alone or together with broadly neutralizing antibodies, can control HIV following the interruption of antiretroviral therapy (ART). The California company said the randomized, open-label study—sponsored by the U.S. National Institute of Allergy and Infectious Diseases—will enroll about 46 people living with HIV who…

Mentions: ImmunityBio, HIV, NIAID, drugs

Iranian state-run news reported Wednesday that Tehran’s Pasteur Institute and India’s Bharat Biotech have agreed to cooperate on a technology transfer that will allow Iran to produce the Indian company’s rotavirus vaccine. The article didn’t reveal any further details about the deal.

The Drugs for Neglected Diseases Initiative (DNDI) announced Monday that Malaysia has become the first country to grant conditional registration to ravidasvir as part of a two-drug treatment for adults with chronic hepatitis C. The collaborators plan to sell the treatment—combining the antiviral, licensed from Presidio Pharmaceuticals to DNDI and Egypt’s Pharco Pharmaceuticals, with a Pharco-produced version of Gilead’s sofosbuvir—at an “…

Chinese regulators have approved an expanded indication of Sinovac’s enterovirus type 71 vaccine, the company announced last week. Cleared in 2015 for children ages 6 months to 3 years, Inlive can now be used from 6 months until children turn 6, according to the press release.

The announcement follows Phase 3 results published in the Journal of the Pediatric Infectious Diseases Society in April showing that Sinovac’s shot demonstrated “…

Mentions: Sinovac, EV71, vaccines

The state of the hunt: 

  • China authorized Sinovac’s vaccine for children as young as age 3.
     
  • The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
     
  • Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.
  Approved or authorized vaccines

China cleared Sinovac’s CoronaVac…

Advaccine has dosed the first participants in a Phase 2 study of ADV110, its adjuvanted protein subunit RSV vaccine candidate, the Chinese company announced last week.

In other news, the company will collaborate with Inovio on a global Phase 3 trial of the Pennsylvania-based company’s DNA Covid-19 vaccine candidate, INO-4800, under an expanded tie-up announced Tuesday.

Johnson & Johnson published on Wednesday its annual environmental, social and governance (ESG) performance report. The 2020 Health for Humanity Report highlighted the company’s Covid-19 response, global health strategy, responsible business practices, and reporting frameworks and standards.

On global health, J&J touted approvals of its Ebola vaccine and long-acting rilpivirine-containing injectable HIV treatment regimen and the…

The Lancet Infectious Diseases published study results on Monday showing that the efficacy of the non-artemisinin-based triple-drug combination arterolane-piperaquine-mefloquine was noninferior to both arterolane-piperaquine and the artemisinin-based combination artemether-lumefantrine for treating uncomplicated P. falciparum malaria.

The study—funded by the Gates Foundation and Wellcome, among others—said the triple combination could “…

Mentions: malaria, ACTs, drugs, BMGF, Wellcome, AMR

Boston University-led nonprofit CARB-X announced Tuesday that it will give Arizona-based Accelerate Diagnostics $578,000 (plus up to $2.1 million in milestones) to develop a rapid optical imaging diagnostic for sepsis and serious antibiotic-resistant bacterial infections.

In other antimicrobial resistance news, Boston’s Selux Diagnostics announced Tuesday an additional $14.6 million award from the U.S. Biomedical Advanced Research and…

The U.S. FDA approved Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV) on Tuesday, handing the company a win over rival Merck for the world’s first next-generation PCV authorization. The shot, Prevnar 20, is also under EMA review, the company’s press release said.

Merck’s 15-valent PCV candidate (V114) may win the pediatric race, however, as the multinational plans to file for a pediatric indication by the end of the year. An FDA…

Mentions: Pfizer, FDA, pneumo, PCV, Merck, vaccines

WHO released detailed notes last week from the March 22-24 virtual meeting of its Strategic Advisory Group of Experts (SAGE) on Immunization.

As in the last SAGE meeting in October 2020, the impact of the pandemic on immunization as well as guidance on Covid-19 vaccines dominated the discussion. WHO’s Immunization, Vaccines and Biologicals (IVB) department director compared the scope of Covid-19 to that of the 1918 influenza pandemic.…

Continuing its breakneck business pace, gene-editing specialist Graphite Bio—a Stanford spinout that just launched in September 2020—filed for an IPO last week.

San Francisco-based Graphite secured U.S. FDA clearance in December 2020 for Phase 1/2 trials of GPH101, its investigational sickle cell therapy.

Merck claimed a $9 billion payday as it finalized its spinoff of women’s health, biosimilars and legacy brands company Organon, which formally launched as an independent, publicly traded entity last week.

Merck will “likely” use the funds for a future acquisition, according to Endpoints News.

Mentions: Merck, Organon, IPOs

Advocates for developing countries manufacturing their own pharmaceutical products received another boost after WHO’s annual World Health Assembly (held May 24-31) passed a resolution (led by Ethiopia) calling for strengthening local production of medical technologies.

The resolution urges WHO member states to “develop evidence-based holistic national and regional policies, financing mechanisms, strategies and plans of action and to…

The state of the hunt: 

  • WHO cleared Sinovac’s vaccine for emergency use.
     
  • Gavi’s COVAX AMC funding summit exceeded its goals, securing $2.4 billion in commitments.
     
  • India ordered 300 million doses of a yet-to-be-authorized Bio E vaccine candidate.
Approved or authorized vaccines

Sinovac’s inactivated vaccine notched WHO Emergency Use Listing on Monday, leaving the shot, CoronaVac…

The U.S. Biomedical Advanced Research and Development Authority (BARDA) announced Monday that it has selected the Global Health Investment Corporation (GHIC)—parent of the Global Health Investment Fund and an investor in Adjuvant Capital—as its venture partner.

BARDA has committed a minimum of $50 million over five years to GHIC, with potential for up to $500 million over 10 years through its BARDA Ventures initiative, according to its…

CARB-X announced Tuesday that it will give Swiss biopharma BioVersys up to $4.3 million (plus up to $11 million in milestones) to develop new antibiotics to treat life-threatening infections caused by multidrug-resistant “ESKAPE” pathogens, including E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa and Enterobacter species.

BioVersys’ novel class of pyrrolocytosine small molecules have exhibited “robust coverage” of all…

Germany plans to pay vaccine companies an annual fee to reserve new manufacturing capacity of approximately 600 million-700 million doses per year to help fight future pandemics, Reuters reported on Wednesday.

The news outlet quoted federal health minister Jens Spahn as saying his government will tender five-year contracts that would activate domestic production capacity when needed. The standby contracts will help maintain know-how…

Seoul’s International Vaccine Institute (IVI) on Monday touted its Gates Foundation award to develop an adaptive trial design protocol for a Phase 1b/2a study of a schistosomiasis vaccine candidate.

A first-in-human safety study of SchistoShield (Sm-p80)—co-developed with Gates funding by Texas Tech and PAI Life Sciences, and using the GLA-SE adjuvant from IDRI—is slated to take place in the United States, followed by a Phase 1b safety…

Mentions: IVI, BMGF, schisto, vaccines

The U.S. National Institutes of Health announced Tuesday the launch of a first-in-human Phase 1 trial of FluMos-v1, a nanoparticle universal influenza vaccine candidate developed by the U.S. National Institute of Allergy and Infectious Diseases.

Healthy adults age 18-50 will receive either the candidate vaccine or a shot of Flucelvax, the cell-based quadrivalent seasonal flu vaccine from Seqirus, per the press release.

In animal…