TAK-919 is Takeda's development code for Moderna's COVID-19 vaccine candidate.
This placebo-controlled Phase 1/2 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
Takeda intends to enroll 200 participants aged 20 years and above in Japan. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
Takeda and Moderna previously announced that Takeda will import and distribute 50 m doses of Moderna's COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA, to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.
Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.
Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Neurocrine Biosciences announces presentation of Osavampator Phase 2 data at Psych Congress 2025
Ascletis presents ASC30 study results at EASD Annual Meeting
Three WuXi Biologics manufacturing facilities receive GMP certification from Turkish regulator
VarmX secures strategic collaboration and option agreement with CSL for novel coagulation therapy
Avidity Biosciences closes USD690m public offering of common stock
Akeso's ligufalimab (CD47 mAb) granted FDA Orphan Drug Designation for AML
Forte Biosciences highlights positive FB102 data in celiac disease at Tampere Symposium
SureSpace Launches in Dubai to Tackle Doomscrolling and Redefine Social Networking
Kodiak reports positive APEX data for KSI-101 in macular edema secondary to inflammation
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial
Phrontline Biopharma doses first patient in TJ101 Phase 1 clinical trial
Gene Solutions' mitochondrial therapy platform targeting neurological diseases secures patent
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Avidity Biosciences prices upsized common stock public offering