The state of the hunt:

  • WHO issued Emergency Use Listing for the inactivated vaccine from CNBG’s Beijing subsidiary.
     
  • Pfizer and BioNTech applied for full U.S. FDA approval of their Comirnaty vaccine.
     
  • Moderna and Novavax inked supply deals with COVAX for at least 850 million combined doses.

 

Vaccines


Approved or authorized vaccines
   
WHO listed…

Serum Institute of India (SII) CEO Adar Poonawalla made headlines this week after reportedly fleeing his company’s Pune headquarters for London with his wife and children, at least partly due to safety concerns. In an interview, Poonawalla cited “threats” from what Financial Times called “unnamed senior politicians and business figures demanding access to vaccines.”

Poonawalla told Financial Times that politicians and critics in India…

Mentions: SII, vaccines, Covid-19

Britain’s Enesi Pharma announced this week positive proof-of-concept results for its separate needle-free thermostable recombinant H7N9 pandemic flu vaccine and measles-rubella candidates. Both shots use the biotech’s ImplaVax actuator technology that delivers dissolvable solid-dose vaccines beneath the skin’s surface.

Enesi is also working on implants against Zika and Shigella and a combination chikungunya-Zika vaccine.

A human challenge trial of Sanaria’s PfSPZ-CVac malaria vaccine candidate left 10 out of 13 subjects “completely immune,” the German Center for Infection Research (DZIF) announced Tuesday.

The chemoprophylaxis-attenuated whole-organism vaccine regimen from Maryland-based Sanaria involves the simultaneous administration of P. falciparum parasites and an antimalarial drug. The research also showed that vaccination with parasites from…

The Lancet Infectious Diseases published a meta-analysis last week of studies comparing the immunogenicity of one-, two- or three-dose regimens of fractional inactivated polio vaccine (fIPV) versus full-dose IPV when used against the three polio serotypes in children age 5 and under.

The researchers reported that seroconversion following a three-dose schedule of fIPV showed “no substantial difference” from three doses of full-dose IPV,…

ImmunityBio announced last week the start of a Phase 2 trial of an investigational HIV treatment “to target and inhibit” early establishment of HIV reservoirs in people with acute HIV infections. The U.S. Walter Reed Army Institute of Research launched the trial of the California-based company’s interleukin-15 (IL-15) superagonist Anktiva (N-803) in combination with antiretroviral therapy. The study will take place at the Thai Red Cross AIDS…

Mentions: ImmunityBio, WRAIR, HIV, ARV, drugs

A leading pharma trade group reacted fiercely to the U.S. government’s Wednesday decision to support a temporary waiver of intellectual property rights for Covid-19 vaccines. The Pharmaceutical Research and Manufacturers of America (PhRMA) said the move would “sow confusion,” “weaken already strained supply chains,” and “foster the proliferation of counterfeit vaccines,” rather than save lives.

Meanwhile, WHO chief Tedros Adhanom…

Seqirus presented new Phase 3 data Monday showing that Flucelvax, its cell-based quadrivalent seasonal influenza vaccine, was as safe and immunogenic as a “standard” quadrivalent flu vaccine in children age 6 months through 4 years.

The U.S. FDA is currently reviewing an application for an expanded indication of the shot for people age 6 months and above, according to the press release.

Mentions: Seqirus, flu, vaccines

Maryland-based Sirnaomics announced last week that it will partner with China’s Walvax to co-develop its STP702 RNA interference-based influenza A therapy candidate.
 
Walvax will shell out $6.4 million upfront (plus additional milestone payments) for exclusive development and commercialization rights for STP702 in territories including China, Hong Kong, Macao and Taiwan, the press release said.

Mentions: Sirnaomics, Walvax, flu, drugs

Vaxart has dosed the first participant in a Phase 1b boosting regimen trial of its norovirus candidate, the San Francisco-based oral vaccine specialist announced Tuesday.

The company said in its press release that WHO has designated norovirus as a priority disease for vaccine development.

ViiV Healthcare has started a rolling submission for U.S. FDA approval of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP), the GSK subsidiary announced Tuesday. The U.S. regulator awarded Breakthrough Therapy Designation to the PrEP formulation in November 2020, after Phase 3 data showed that an injection every two months was 89% more effective than Gilead’s daily Truvada (emtricitabine/tenofovir disoproxil…

WHO added São Paulo-based Butantan Institute’s trivalent inactivated seasonal flu vaccine and two Ebola shots from J&J’s Janssen subsidiary—Ad26.ZEBOV-GP and MVA-BN-Filo, used in combination—to its list of prequalified products last week.

Twelve leading pharma companies released first-quarter 2021 financial results in April. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, Abbott’s first-quarter worldwide sales jumped 32.9% over last year’s to $10.5 billion, missing consensus estimates by 3.5%. Its diagnostics business continued to boom, with strong Covid-19 test sales driving 115% growth. The company said it has delivered nearly…

The state of the hunt:

  • Moderna’s mRNA-based vaccine secured Emergency Use Listing from WHO.
     
  • Merck entered voluntary licensing agreements with five Indian drugmakers for its investigational antiviral molnupiravir.
     
  • Biological E’s subunit vaccine candidate advanced to Phase 3.

 

Vaccines


Approved or authorized vaccines
    
WHO granted Moderna’s…

Boston University-led CARB-X announced Tuesday that it will give British diagnostics company GenomeKey $3 million (plus up to $6.5 million in milestones) to develop a four-hour test for sepsis. The diagnostic uses machine learning to identify bacterial species and test for antibiotic sensitivity, allowing clinicians to prescribe targeted drugs quickly and “reduce unnecessary antibiotic consumption,” the press release said.

Meanwhile,…

Oxford-based Exscientia announced Monday that it has raised $225 million in Series D financing and up to $300 million in an equity investment from the SoftBank Vision Fund 2, which led the round. The AI-driven company will use the funds to advance its proprietary pipeline through clinical testing and expand its technology platform toward “autonomous drug design,” the press release said.

Bristol Myers Squibb, Farallon Capital and Novo…

Researchers from Oxford University’s Jenner Institute published data last week showing that their candidate prophylactic malaria vaccine achieved 77% efficacy over 12 months of follow-up in Phase 2b trials in children age 5-17 months. The study, in Burkina Faso, started in 2019.

The adjuvanted R21/Matrix-M shot—the first to achieve WHO’s goal of at least 75% efficacy—showed a favorable safety profile and was well-tolerated, leading the…

Merck announced Monday that it aims for carbon-neutral operations by 2025 and a 30% cut in emissions across its entire value chain by 2030. The company also touted a 15-year acceleration in its drive to source 100% renewable energy for its purchased electricity—moving up the target year from 2040 to 2025.

Merck said it plans to reach these goals by using virtual power purchase agreements for renewable energy, applying sustainable…

Mentions: Merck, climate change

A single-dose monoclonal antibody (mAb) to prevent RSV in infants met its primary Phase 3 endpoint “earlier than anticipated,” co-developers AstraZeneca and Sanofi announced Monday.

Nirsevimab reduced RSV-related lower respiratory tract infections in healthy infants compared to placebo through a typical RSV season, according to the press release.

Endpoints News quoted Sanofi CEO Paul Hudson as pledging to make the single-shot…

An Indian pharmacy chain backed by Serum Institute of India CEO Adar Poonawalla is planning an initial public offering, Hindustan Times reported Sunday, citing anonymous sources. The potential $160 million IPO would make Wellness Forever the first retail pharmacy chain listed on an Indian stock exchange, according to the article.

Poonawalla and his co-investors pumped more than $17 million into the company in November 2020, per local…

Mentions: SII, IPOs