London’s Pulmocide announced last week that it has raised $92 million in Series C financing in a round led by Jeito Capital with help from new investors, including Adjuvant Capital.

Backed by J&J Innovation, Pulmocide will primarily use the funds to advance its PC945 inhaled novel triazole antifungal candidate through global Phase 3 studies in patients with invasive pulmonary aspergillosis who have failed prior therapy, the press…

Mentions: Pulmocide, J&J, drugs

Seven leading pharma companies released first-quarter 2021 financial results in May, while one Japanese firm reported full-year 2020 results for the fiscal year ending in March. (Figures exclude exchange rate and portfolio changes where applicable.)
 
Leading the pack, first-quarter sales for South Korea’s newly public SK Bioscience soared 397% year-over-year to $101.1 million, as its Covid-19 vaccine CMO business started “making…

The state of the hunt: 

  • Moderna’s vaccine showed high efficacy in adolescents.
     
  • U.S. regulators cleared a monoclonal antibody from GSK and Vir for emergency use.
     
  • Sanofi and GSK launched the Phase 3 trial of their vaccine candidate.
  Approved or authorized vaccines

Moderna touts data for teens: Less than two months after Pfizer and BioNTech boasted of their mRNA-based jab’s 100…

New York’s Codagenix and Brussels-based biomanufacturing platform company Univercells will collaborate on an undisclosed, “high-priority human vaccine target with global public health demand,” the companies announced last week.

Univercells will assess the live attenuated candidate from Codagenix with an eye toward eventual commercial production on its proprietary manufacturing platform, according to the joint press release.

Days after its CEO faced withering criticism from U.S. lawmakers over production mistakes with Covid-19 vaccines, Emergent BioSolutions had rosier news: two-year persistence data from a Phase 2 trial of the Maryland-based company’s chikungunya virus-like particle vaccine candidate (CHIKV-VLP) showed mean neutralizing antibody titers 19 times higher than pre-vaccination titers, according to a Wednesday press release.

Citing the lasting…

Merck announced positive topline results last week for its investigational 15-valent pneumococcal conjugate vaccine (PCV), which met primary endpoints in two Phase 3 pediatric studies. The data suggested that V114 protects against 13 serotypes in infants who previously received one or multiple doses of Pfizer’s 13-valent shot and against 15 serotypes in children age 7 months to 17 years in a catch-up setting, according to a Merck press…

Takeda released three-year Phase 3 follow-up results for its tetravalent dengue vaccine last week—reporting 83.6% efficacy in preventing hospitalization and 62% efficacy against the disease overall, per its press release.

The company found no important safety risks and observed no evidence of disease enhancement in dengue-naïve participants, according to the press release. Sanofi’s Dengvaxia was discontinued by the Philippine government…

The state of the hunt:

  • J&J, Moderna and Pfizer/BioNTech pledged to provide 3.5 billion vaccine doses to LMICs at low cost.
     
  • Sanofi touted favorable interim Phase 2 results for its protein-based vaccine candidate.
     
  • Serum Institute of India pushed back its timeline to resume exporting vaccine doses to COVAX.

 

Approved or authorized vaccines

 
India’s review…

Boston University’s CARB-X consortium announced two new investments this week.

On Tuesday, the nonprofit said it will give Massachusetts-based Summit Therapeutics up to $4.1 million (plus up to $3.7 million in milestones) to develop its first-in-class SMT-738 antibiotic candidate for treating multidrug-resistant infections—specifically carbapenem-resistant Enterobacteriaceae (CRE) infections caused by pathogens including E. coli and K.…

Japan’s Global Health Innovative Technology (GHIT) Fund on Tuesday announced $8.8 million in drug and diagnostic development investments for neglected tropical diseases.

Two awards will support new projects for separate Buruli ulcer and Chagas disease tests. Meanwhile, two additional awards will fund new partnerships between the Drugs for Neglected Diseases Initiative and Japanese partners for leishmaniasis drug discovery and…

J&J announced last week that it will donate up to 200,000 doses of its Ebola vaccine regimen (developed with Bavarian Nordic) to Sierra Leone as part of a WHO early access clinical program to prevent disease spread in the region. Neighboring Guinea declared a new Ebola outbreak in February.

WHO awarded prequalification status last month to the dual-shot regimen, comprised of Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).

Maryland’s Integrated BioTherapeutics announced Wednesday a U.S National Institute of Allergy and Infectious Diseases contract worth up to $16.3 million to develop IBT-T03H, a monoclonal antibody for treatment of Marburg virus disease, and potentially bring the candidate to Phase 1.

The company previously won CARB-X support for its Staphylococcus aureus vaccine candidate, IBT-V02.

HDT Bio announced on Monday a three-year, $2.9 million grant from the U.S. National Institute of Allergy and Infectious Diseases to develop a “low cost and easy to manufacture” HIV-1 RNA vaccine.

The company said the shot will use the same Lipid InOrganic Nanoparticle (LION)-based self-replicating RNA technology as its Covid-19 vaccine candidate, HDT-301, which is currently in clinical trials in India.

Mentions: HDT Bio, NIAID, HIV, vaccines

New Delhi-based Panacea Biotec has filed a patent infringement suit against Sanofi in an Indian court, per local media, reportedly seeking to block the multinational from launching a hexavalent vaccine in the country that would compete with Panacea’s EasySix. Sanofi disputed Panacea’s patent in 2017, the Times of India said.

Serum Institute of India, a minority shareholder of Panacea, supplies IPV for EasySix and holds co-marketing…

Mentions: Panacea, Sanofi, hexa, vaccines, SII

Contemporary Clinical Trials published an analysis from Pfizer last month of diversity metrics (including age, ethnicity, gender and race) from 213 of the company’s U.S. clinical trials enrolled between 2011 and 2020.

The results—characterized by Endpoints News as “par for the course in biopharma”—compared trial enrollment to U.S. census data and showed proportionate representation across age and gender for Black or African American,…

Mentions: Pfizer

The Lancet published Phase 1 results on Tuesday from a trial of Takeda’s Zika vaccine candidate, TAK-426. A three-dose regimen of the purified, inactivated vaccine candidate was well-tolerated, had an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults, according to the article.

Mentions: Takeda, Zika, vaccines

The state of the hunt:

  • A trial of Bharat Biotech’s vaccine in children age 2-18 advanced to Phase 2/3.
     
  • China authorized its sixth vaccine.
     
  • The United States started vaccinating adolescents age 12-15 with Pfizer/BioNTech’s shot.

 

Vaccines


Approved or authorized vaccines
  
The U.S. FDA expanded its authorization of Pfizer/BioNTech’s Covid-19…

JAMA Network Open published a Yale-led study last week that showed new medicines and vaccines approved for use in the United States are often unavailable in countries that hosted their clinical trials, raising “concerns about the equitable distribution of research benefits,” according to a university press release.

The cross-sectional study examined clinical trials sponsored by large companies for 34 novel drugs approved by the U.S. FDA…

Boston University-led CARB-X announced Monday that it will give Australian diagnostics specialist SpeeDx up to $1.8 million (plus up to $1.9 million in milestones) to develop a one-hour combination test for chlamydia and gonorrhea that also determines the susceptibility of gonorrhea infections to common antibiotics. SpeeDX plans to combine its test with a portable, battery-operated device from Britain’s QuantuMDx, making the diagnostic ready…

The tri-antigenic hepatitis B shot from VBI Vaccines showed either non-inferiority (in people age 18 or older) or superiority (in people age 45 and older) to GSK’s single-antigen Engerix-B in Phase 3 findings published Tuesday in The Lancet Infectious Diseases.

The results—which improve on prior studies—give a boost to the Massachusetts-based company as it positions Sci-B-Vac to compete with GSK’s more established product.

Mentions: VBI, GSK, hep B, HBV, vaccines