The United States Food and Drug Administration (FDA) has granted fast track designation to United States-based Moderna for its investigational Zika vaccine, mRNA-1893, it was reported yesterday.
Presently, the mRNA-1893 vaccine is being evaluated in a phase one study to prevent Zika virus infection in healthy adults. The product included an mRNA sequence that encodes for the structural proteins of Zika virus. It is designed to help cells to secrete virus-like particles, helping to mimic the response of the cell after natural infection.
The phase 1 trial is evaluating the safety, pharmacokinetics and pharmacodynamics of the product in healthy volunteers. The company's randomised, observer-blind, placebo-controlled and dose-ranging study has been framed to evaluate the safety, tolerability and immunogenicity of mRNA-1893 in healthy flavivirus seropositive and seronegative adults aged between 18 and 49 years.
Anixa Biosciences transfers breast cancer vaccine IND from Cleveland Clinic
Physiomics secures follow-on UK contract for Phase 2 study support
Ascletis reports positive US Phase I data for oral IL-17 inhibitor ASC50
Dimerix completes adult recruitment in ACTION3 Phase 3 DMX-200 trial
RedHill Biopharma reports positive opaganib data in venetoclax-resistant CLL
Vanda files FDA Biologics License Application for imsidolimab in generalized pustular psoriasis
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion
Amgen's UPLIZNA receives US FDA approval
Innovent Biologics' mazdutide injection meets Phase 1b clinical study primary endpoint
FDA grants priority review to Bristol Myers Squibb's Opdivo regimen for advanced Hodgkin lymphoma
Physiomics secures new contract with Numab Therapeutics for preclinical antibody development
OTR Therapeutics agrees strategic collaboration and licence agreement with Zealand Pharma A/S