The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a $26 million West African Lassa fever research program, a coalition press release said last week.

Up to 23,000 participants across outbreak-prone Benin, Guinea, Liberia, Nigeria and Sierra Leone will take part over the next 24 months in “Enable”—the largest Lassa fever research program in the region to date, according to CEPI.

Findings from Enable will guide…

The state of the hunt:

  • The Pfizer/BioNTech vaccine received several new authorizations, including from the European Union.
     
  • Canada joined the U.S. in authorizing Moderna’s jab. .
     
  • Argentina and Belarus became the first countries outside Russia to OK Sputnik V.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech will market their…

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced last week that it has signed a memorandum of understanding with India’s Dr. Reddy’s and Aurigene Pharmaceutical Services to explore joint opportunities to make novel drug-resistant gonorrhea treatment zoliflodacin “accessible in low- and middle-income countries (LMICs), including South Africa, Thailand and India.”

The press release did not detail…

Fast out of the starting gate, new gene editing entrant Graphite Bio announced last week that it has already won the go-ahead for Phase 1/2 trials of its sickle cell gene editing therapy, GPH101. The San Francisco-based company also announced this week that former Novartis CEO Joe Jimenez and former Celgene executive Perry Karsen have joined its board of directors.

Graphite Bio launched in September 2020.

Netherlands vaccine maker Intravacc announced Tuesday that it will become a public shareholding company effective January 1, 2021.

The Dutch government will remain Intravacc’s sole shareholder, however—a detail not previously clear in prior press releases about the company’s privatization.

Florida-based Ridgeback Therapeutics on Tuesday announced U.S. FDA approval of its mAb114 (now branded as Ebanga) for treatment of Ebola in children and adults.

The monoclonal antibody therapy and Regeneron’s REGN-EB3 triple-antibody cocktail (now branded as Inmazeb) were shown to be superior in 2019 clinical trials to MappBio’s ZMapp and Gilead’s remdesivir for treatment of Ebola.

Regeneron’s Inmazeb won U.S. FDA approval in…

Seoul’s International Vaccine Institute (IVI) announced Thursday that SK Bioscience’s Vi-DT typhoid conjugate vaccine (TCV) has met the primary endpoints in Phase 3 trials in Nepal.

The diphtheria toxoid-based candidate induced an immune response that was non-inferior to Bharat Biotech International Limited’s WHO-prequalified Typbar-TCV and was shown to be safe in all 1,350 participants (ages 6 months to 45 years).

IVI, which…

Belgium-based biomanufacturing platform company Univercells announced last week that it has completed a second round of Series C financing—adding $24 million to the $61 million it raised several months ago and bringing total funds raised this year to $146 million. This latest round of financing will support “distributed manufacturing and supply of biologics” and the development of GMP facilities to address “manufacturing bottlenecks for…

WHO awarded prequalification (PQ) status last week to AstraZeneca’s H5N1 live-attenuated intranasal spray.

Mentions: WHO, flu, vaccines, AstraZeneca, PQ, H5N1

WHO’s Market Information for Access (MI4A) to Vaccines initiative last week released its annual Global Vaccines Market Report (GVMR) and a new market study on rabies vaccines.

The GVMR said that while it cannot yet show the impact of Covid-19, the pandemic is “likely to alter vaccine markets for several years.” WHO estimated global vaccine market volumes for 2019 of 5.5 billion doses, with a global market value of $33 billion (both…

The state of the hunt:

  • Moderna’s became the second Covid-19 vaccine to receive U.S. FDA Emergency Use Authorization.
     
  • COVAX has secured nearly 2 billion doses of vaccines but faces a “very high” failure risk, according to Reuters.
     
  • Canada, Saudi Arabia and the United States have begun immunization campaigns using Pfizer/BioNTech’s jab.

 

Vaccines


Approved or…

Evaluate issued its annual markets forecast Thursday, leading with the safe prediction that Covid-19 will continue to dominate interest: as a result of the pandemic, some pharma and biotech companies will start 2021 “bolstered by substantial financial support” and sporting “eye-watering” valuations.

The analyst group said Pfizer/BioNTech’s BNT162b2 shot will lead 2021 sales of Covid-19 vaccines but predicts that Moderna’s jab will be…

UK-based Exscientia announced last week a $4.2 million drug discovery grant from the Gates Foundation to use the company’s AI-driven platforms to find small molecule candidates for malaria, non-hormonal contraceptives and tuberculosis.

Exscientia has drug discovery collaborations with several companies, including Bayer, Bristol Myers Squibb, GSK and Sanofi.

In another boost for the novel type 2 oral polio vaccine (nOPV2) following WHO’s Emergency Use Listing (EUL) of it last month, The Lancet published positive Phase 2 data last week from two studies comparing nOPV2 to the monovalent type 2 oral polio vaccine (mOPV2).

The studies found that two nOPV2 candidates were equally well-tolerated in infants, children and adults, with comparable immunogenicity within each cohort. The authors of…

Mentions: Polio, vaccines, nOPV, WHO, EUL, mOPV

Findings published in The Lancet last week support the use every two months of the injectable two-drug HIV regimen containing ViiV’s cabotegravir and J&J’s rilpivirine for long-acting maintenance of viral suppression in people living with HIV-1.

The European Medicines Agency also gave GSK subsidiary ViiV a nod for Rukobia (fostemsavir)—the company’s novel attachment inhibitor for the treatment of adults with multidrug-resistant…

Mentions: ViiV, J&J, drugs, HIV, EMA, GSK

The rush by pharma companies to add to an already banner year for mergers and acquisitions continued in recent days.

First, Gilead announced last week that it is buying German chronic hepatitis specialist MYR Pharmaceuticals for almost $1.8 billion in cash and milestone payments.

Next, AstraZeneca said it would scoop up Boston-based immunology company Alexion Pharmaceuticals for $39 billion in cash and equity to build the British-…

Local media reported last week that Patrick Ajah will replace Nnamdi Okafor as May & Baker’s CEO on January 1, 2021. Okafor is retiring from the Nigerian pharma company after nearly 10 years at the helm.

Denmark’s MinervaX announced Tuesday that it has raised $57 million to advance its protein-only Group B Streptococcus (GBS) vaccine candidate through Phase 2 and to prepare for Phase 3 trials.

According to the press release, the Series B round “included Sanofi Ventures, Wellington Partners, Adjuvant Capital and Industrifonden”—along with existing investors Novo Holdings REPAIR Impact Fund, Sunstone Life Science Ventures and LF…

The TB Alliance announced Tuesday the dosing of the first participant in Phase 1 trials of TBAJ-587, its novel diarylquinoline compound that demonstrated a superior preclinical profile against M. tuberculosis, according to the press release.

In other TB news, the UN-backed Medicines Patent Pool announced last week that it has sublicensed patents and know-how relating to the investigational antibiotic sutezolid to the Gates Medical…

Two companies last week extended a veritable frenzy of recent industry capacity enhancement announcements.

Massachusetts-based Thermo Fisher said it will expand its sterile drug development and commercial manufacturing facilities—including live virus, aseptic liquid and lyophilized vial filling capabilities—in North Carolina, the United Kingdom and Italy. The expansions are in addition to new facilities in Singapore and China the…