GSK announced Tuesday that it has dosed the first participant in a Phase 3 trial of its recombinant subunit prefusion RSV vaccine candidate for older adults.

The company began Phase 3 trials for a second RSV candidate (for maternal immunization) in November 2020 and is testing a third RSV shot for infants in ongoing Phase 1/2 studies.

In other news, GSK announced Wednesday that it is increasing its diversity targets for senior…

Mentions: GSK, RSV, vaccines

GSK and Vir Biotechnology announced Wednesday that they are expanding their existing Covid-19 therapeutics collaboration to include research and development of treatments for influenza and other respiratory viruses, and exploration of up to three monoclonal antibodies to target non-influenza pathogens.

GSK will pay Vir $225 million upfront, increase its equity investment in the San Francisco-based biotech by $120 million, and shell out…

Mentions: GSK, Vir, Covid-19, R&D, flu, mAbs, drugs

Novartis’ generics subsidiary Sandoz announced last week an agreement to acquire GSK’s cephalosporin antibiotics business for $350 million upfront, plus up to $150 million in milestones.

The deal includes rights in more than 100 markets to three established brands with combined 2020 sales of $140 million, according to Novartis.

Novartis also invested in antibiotic expansion last year.

Novartis announced Wednesday a collaboration with the Gates Foundation to develop an accessible in vivo gene therapy for sickle cell disease (SCD) that could potentially be administered once, directly to a patient, without the need to modify the cells in a lab. The collaboration aims to provide affordable and practical gene therapy for low-resource settings, the press release said.

In other SCD news, Massachusetts-based Bluebird Bio…

Evolve BioSystems announced observational study results on Tuesday showing that preterm infants fed its activated B. infantis probiotic (EVC001) had a “significantly lower level of intestinal inflammation, 62% less diaper rash, and required 62% fewer antibiotics.” Frontiers in Pediatrics published the results.

Evolve also reported last week that it has raised $55 million in Series D financing, led by food products group Cargill and…

The Annals of Internal Medicine published positive Phase 1 results on Tuesday of the Ad26.ZIKV.001 replication-incompetent adenovirus-vectored prophylactic Zika vaccine from J&J’s Janssen subsidiary.

Both one- and two-dose regimens in healthy adults were safe and well-tolerated and produced neutralizing antibodies that persisted for at least one year, the article said. The antibodies also offered protection against the virus when…

Mentions: J&J, Janssen, Zika, vaccines

The state of the hunt:

  • Russia’s Sputnik V vaccine has reportedly been authorized in 26 countries.
     
  • SAGE recommended that all countries proceed with planned rollouts of the AstraZeneca/Oxford jab, while the Africa CDC offered more cautious guidance, amid reports of low efficacy against viral variants.
     
  • Tanzania has no plans to mount a Covid-19 immunization campaign.

 

Basel-based Lonza announced Monday that it will sell its specialty ingredients division to private equity firms Bain Capital and Cinven for $4.7 billion, allowing the CDMO to “refocus its business” on the healthcare industry, according to its press release.

In other CDMO news, Shanghai-based WuXi AppTec subsidiary WuXi STA announced last week that it will buy Bristol Myers Squibb’s tablet and capsule manufacturing facility in Couvet,…

Mentions: Lonza, CDMOs, Wuxi, BMS

Merck announced last week that CEO Ken Frazier will hand over the reins to CFO Robert Davis on June 30. After stepping down, Frazier will continue to serve on Merck’s board of directors as executive chair during the transition period.

In other executive news, Eli Lilly announced Tuesday that it has appointed company veteran Anat Ashkenazi as CFO after an internal investigation revealed “inappropriate” behavior from now ex-CFO Josh…

Mentions: Merck, Lilly

The International AIDS Vaccine Initiative (IAVI) and Scripps Research announced promising results last week from a Phase 1 trial of a novel vaccine approach for HIV.

The eOD-GT8 60mer vaccine compound elicited the targeted antibody response in 97% of participants who received the shot, according to the press release. The Gates Foundation-funded project seeks ultimately to develop a multistep vaccine regimen aimed at eliciting many…

Pfizer announced Tuesday the launch of a new partnership with the Netherlands-based IDA Foundation to provide “equitable access to quality cancer treatments” in almost 70 low- and middle-income countries across Latin America, Asia, Africa and the Western Pacific region.

The agreement will allow developing country governments and non-governmental organizations to access 18 essential cancer treatments and 30 formulations from Pfizer’s…

Zydus Cadila announced last week that its ZY19489 (MMV253) malaria radical cure, co-developed with the Medicines for Malaria Venture, has succeeded in Phase 1.

The Ahmedabad-based company said healthy volunteers in Australia safely received escalating doses of 25 to 1,500 mg of the oral antimalarial compound. An additional P. falciparum malaria human challenge trial showed no serious or severe drug-related adverse events.

The…

Dynavax and Serum Institute of India (SII) announced last week the dosing of the first participant in a Phase 1 trial of their potentially more durable Tdap (tetanus, diphtheria and acellular pertussis) vaccine candidate combining SII’s antigens and the California company’s CpG 1018 adjuvant.

The press release quoted SII CEO Adar Poonawalla as saying the product would protect “children, adolescents and adults in the developed world.”

The state of the hunt:

  • Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
     
  • J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
     
  • Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

CARB-X announced two new investments in the first days of February.

The Boston University-led nonprofit will award up to $12.2 million to France’s Mutabilis to develop a new intravenous drug to treat infections caused by carbapenem-resistant Enterobacterales (CRE) bacteria.

CARB-X will also invest up to $17.2 million in California-based diagnostics specialist Avails Medical to fund the company’s high-speed electronic antibiotic-…

Evotec has dosed the first participant in a Phase 1 study of EVT894, its monoclonal antibody (mAb) to treat and potentially prevent chikungunya infections, the company announced last week.

Sanofi initially developed the mAb and licensed it to Evotec as part of the 2018 transfer of Sanofi’s Lyon-based infectious disease R&D unit to the German company, according to the press release.

Gilead and California-based biotech Gritstone Oncology announced Monday a $60 million collaboration, option and license agreement to develop a vaccine-based immunotherapy for HIV that uses Gritstone’s proprietary self-amplifying mRNA and adenoviral vector-based vaccine platform.

Gritstone will receive $30 million in cash and $30 million in an equity investment from Gilead, along with up to $725 million in milestone payments and…

Ireland-based rare diseases company Horizon Therapeutics announced Monday that it will buy AstraZeneca spinoff Viela Bio for $3.1 billion—acquiring the Maryland-based biotech’s rare disease medicines portfolio, which includes four drug candidates in nine development programs.

AstraZeneca has agreed to divest its nearly 30% ownership in Viela as part of the acquisition and expects to net up to $780 million once the deal is closed, the…

The Journal of Clinical Investigation Tuesday published positive Phase 1 results from a U.S. National Institute of Allergy and Infectious Diseases trial showing that Maryland-based Emergent BioSolutions’ single-dose intranasal, recombinant, replicating adenovirus influenza vaccine (Ad4-H5-VTN) was safe and produced a durable immune response.

Participants who received the investigational vaccine intranasally or via tonsillar swab had…

Four pharma companies recently announced moves to increase access to medicines.

Ahead of World Neglected Tropical Disease (NTD) Day (January 30), Novartis renewed its leprosy multidrug therapy donation program with WHO—extending the commitment by five years to the end of 2025. The agreement also includes the donation of fascioliasis drug triclabendazole.

On the same day, Germany’s Merck KGaA announced that it will provide an…