Takeda Pharmaceutical Company Limited announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately 15 months after Takeda received a contract to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA). [i]
The randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the investigational vaccine candidate in 240 male and female subjects between the ages of 18 and 49. The Phase 1 trial also will assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.[ii] The trial will take place in the continental U.S. and U.S. territories and is being conducted under a U.S. Investigational New Drug (IND) application.
“We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda. “This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”
Takeda was selected by BARDA in September 2016 to develop a vaccine to support the Zika response effort in the U.S. and affected regions around the world.
In recent years, the Zika virus has had a devastating impact, spreading across more than 84 countries, territories or subnational areas, including the U.S.[iii] In February 2016, the World Health Organization (WHO) declared the Zika outbreak to be a Public Health Emergency of International Concern (PHEIC)[iv] and the Centers for Disease Control and Prevention (CDC) elevated its response efforts to its highest level (Level 1).[v] Although WHO has since declared an end to the PHEIC,[vi] Zika continues to pose a significant threat to public health, especially for pregnant women, and a vaccine is still needed.
Given the public health threat posed by Zika, Takeda mobilized a multifunctional team immediately following signature of the contract with BARDA and has prioritized all aspects of the development program, enabling the Phase 1 trial to start within 15 months of funding.1 Initial data from ZIK-101 are expected in 2018, and, if available Phase 1 data support it, Takeda will work toward initiating Phase 2 studies as soon as possible.2
“BARDA remains committed to making available safe and effective Zika vaccines,” said Rick Bright, Ph.D., BARDA Director. “Takeda’s Phase 1 clinical study is an important step toward this goal.”
Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.
Acknowledgment of Federal Funding
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.
About Takeda’s Zika Virus Vaccine Candidate (TAK-426)
Takeda’s Zika virus vaccine candidate (TAK-426) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine. The candidate is being developed as part of a broader effort to prevent the spread of the Zika virus in susceptible populations around the world.
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health.[vii] For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries.
For more information, visit https://www.takeda.com/newsroom
Contact:
For media outside of Japan:
Elissa Johnsen
TEL: +1-224-554-3185
elissa.johnsen@takeda.com
For Japanese media:
Tsuyoshi Tada
TEL: +81-3-3278-2417
tsuyoshi.tada@takeda.com
