Authors: Martha Powell, Future Science Group
Take a look at this month’s industry headlines including an FDA approval for a vaccine protecting against six diseases, positive clinical trial results for bacteraemia and new funding for CRSIPR-based antimicrobials.
- Takeda’s dengue vaccine meets primary endpoint in Phase III trial
- FDA approves vaccine that prevents six diseases
- J&J finance CRISPR-based antimicrobials from Locus Biosciences
- Positive Phase II trial results for Contrafect’s exebacase against S. aureus
- FDA asks for more data on Starpharma’s bacterial vaginosis therapy
Takeda’s dengue vaccine meets primary endpoint in Phase III trial
Takeda (Osaka, Japan) has announced that its live-attenuated tetravalent vaccine candidate TAK-003 has met its primary endpoint in a Phase III efficacy trial. The vaccine proved effective at preventing dengue fever in children and adolescents living in dengue-endemic countries and was well tolerated.
Moreover, TAK-003 appeared to prevent dengue fever caused by the four serotypes of the virus. The trial is ongoing with additional results expected alter this year, along with results from other Phase II studies. Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit at Takeda, commented: “We are very encouraged by the performance of our dengue vaccine candidate in the study. This brings us one step closer to helping the world tackle the massive burden of dengue.”
FDA approves vaccine that prevents six diseases
Sanofi (Paris, France) and MSD (NJ, SUA) have received FDA approval for Vaxelis, a vaccine that can protect children against six different diseases; diptheria, tetanus, pertussis, poliomyelitis, hepatitis B and disease due to Haemophilus influenzae type B.
The companies are currently working on establishing a supply to meet the anticipated demand, the vaccine won’t be available until 2020.
J&J finance CRISPR-based antimicrobials from Locus Biosciences
Just over a year after securing initial financing, Locus Biosciences (NC, USA) has signed up with J&J (NJ, USA) to fund its CRISPR-based antimicrobials, obtaining a US $20 million upfront fee. Along with this fee, J&J are also offering another $798 million in milestones for CRISPR-Cas3 drugs targeting two bacterial pathogens.
The deal centers on the development of CRISPR-Cas3-engineered phage (crPhage) drugs against bacterial pathogens. Locus’ CEO Paul Garofolo commented: “Our collaboration with Janssen…reflects the importance of the crPhage platform and its potential to revolutionize the treatment of disease and extend human life.”
Positive Phase II trial results for Contrafect’s exebacase against S. aureus
Contrafect’s (NY, USA) exebacase (CF-301), a recombinantly-produced lysin, has demonstrated positive results in a Phase II trial, with improved clinical outcomes in Staphylococcus aureus bacteraemia compared with the standard-of-care. This suggests that this new class of lysin biologics could improve treatment outcomes in serious infections.
Chairman and Chief Executive Officer Steven Gilman commented: “We are very pleased with the strong efficacy signals and the encouraging safety and tolerability profile of our lead first-in-class therapeutic product candidate in this study, which establish the potential for exebacase to substantially improve the clinical responder rates for serious antibiotic-resistant infections seen with antibiotics alone.
“These data support progression to Phase 3 and the potential to provide superior clinical responder rates for Staph aureus bacteremia including right-sided endocarditis.”
FDA asks for more data on Starpharma’s bacterial vaginosis therapy
The US FDA will require more clinical data before it will consider approval for Starpharma’s (Melbourne, Australia) bacterial vaginosis therapy, VivaGel BV. Shares In the company fell nearly 30% following the news.
The FDA application was passed on data from two Phase III studies, which demonstrated VivaGel BV was superior compared with a placebo in preventing recurrent vaginosis. The therapy is currently approved in the EU and Australia, with initial launches planned in the first half of 2019.