Phase 1/2 study expected to enroll 200 adult participants in Japan
CAMBRIDGE, MA, USA I January 21, 2021 IModerna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd (NYSE: TAK). TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate.
“We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for partnering with us to potentially protect the Japanese population from COVID-19 with a vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna.
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. The ClinicalTrials.gov identifier is NCT04677660.
Takeda and Moderna previously announcedthat Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.
About Moderna
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 (mRNA), 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.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
SOURCE: Moderna Therapeutics
Post Views: 75
Phase 1/2 study expected to enroll 200 adult participants in Japan
CAMBRIDGE, MA, USA I January 21, 2021 IModerna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd (NYSE: TAK). TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate.
“We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for partnering with us to potentially protect the Japanese population from COVID-19 with a vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna.
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. The ClinicalTrials.gov identifier is NCT04677660.
Takeda and Moderna previously announcedthat Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.
About Moderna
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 (mRNA), 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.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
SOURCE: Moderna Therapeutics
Post Views: 75
