MEDICAGO
16.12.2021 20:02:09 CET | Business Wire | Press release
Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to announce submission of the positive Phase 3 data for regulatory review by Health Canada as part of the New Drug Submission for COVID (NDS-CV) rolling review for Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant. Medicago is seeking review and approval for the vaccine candidate for indication in healthy adults, aged 18 years and above.
“We are pleased to submit our Phase 3 data as the final portion of the rolling submission for our COVID-19 vaccine candidate for review,” said Dr. Judith Atkins, Vice-President of Regulatory Affairs at Medicago. “We are grateful to Health Canada for their review, and we hope this brings Canadians and the world one step closer to having greater vaccine diversity.”
Thomas Breuer, Chief Global Health Officer, GSK, added: “We are one step closer to our goal of making this innovative adjuvanted, plant-based vaccine available. As a refrigerator-stable option that builds on our established adjuvant technology, we are hopeful it will play an important role in the efforts to overcome the COVID-19 pandemic.”
The New Drug Submission for COVID (NDS-CV) process allowed the submission of nonclinical sections, quality, clinical safety, and efficacy information as they became available for Health Canada’s immediate review to accelerate the overall review process. Submitting the Phase 3 data completes the submission process.
The regulatory filing process for the COVID-19 vaccine candidate has been initiated with the FDA (US) and MHRA (UK). Preliminary discussion is underway with the WHO for preparation of the submission. A Phase 1/2 trial has also been initiated in Japan where Medicago plans to submit for regulatory approval in combination with the Phase 2/3 global study results next spring. The vaccine candidate has not yet been approved by any health authorities.
“If authorized, Medicago’s COVID-19 vaccine would be the world’s first ever plant-based vaccine approved for human use,” said Takashi Nagao, CEO and President of Medicago. “It would also be the first Canadian vaccine approved in over 20 years, signaling a powerful step forward for Canada’s vaccine preparedness strategy.”
About Medicago
Medicago is on a mission to help improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-based therapeutics. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide. Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation. For more information: www.medicago.com
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC) Group, the majority parent company of Medicago, is one of the large Japanese pharmaceutical companies, with its headquarters in Osaka, Japan. It positions vaccines as one of its key R&D areas under its Medium-Term Management Plan 21-25 and is also working to develop new modalities of vaccines. MTPC Group will further contribute to the prevention of infectious diseases which is one of the world’s important social issues, by delivering a new option of plant-based VLP vaccine as a new type of vaccine. For further information please visit https://www.mt-pharma.co.jp/e/ .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005780/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Azalea Vision Enrolls First Patient in Proof-of-Concept Study Evaluating Novel Optical Aperture for Keratoconus and Presbyopia28.9.2026 16:27:00 CEST | Press release
Azalea Vision has enrolled the first patient in its NOA proof-of-concept study, launching the company’s clinical program. The study evaluates a Novel Optical Aperture (NOA) inside a contact lens in two patient groups, keratoconus and presbyopia. Clinical study results are expected to inform the planned first-in-human evaluation of Azalea’s fully integrated smart contact lens platform in Europe and the United States. Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced that it has enrolled the first patient in its NOA proof-of-concept study. The study marks the start of Azalea’s clinical program, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928982998/en/ Novel Optical Aperture smart lens The study is conducted at Visser Contact Lenses (Netherlands) and the University Hospital Antwerp
Xsolla Releases The Xsolla Report: Mobile D2C Edition28.9.2026 15:00:00 CEST | Press release
New Data From More Than 800 Mobile Web Shops Finds Direct-to-Consumer Has Become a Standard Operating Discipline, With Top Performers Capturing More Than Half of a Title's Revenue Regardless of Studio Size Xsolla, a global commerce company, today released The Xsolla Report: Mobile D2C Edition, a new study examining how direct-to-consumer commerce is performing across mobile games. Drawing on data from more than 800 live Xsolla Web Shops alongside public market and regulatory data, the report shows that D2C has moved past the question of whether it works and into a new phase: studios seeing the strongest results are the ones treating their Web Shop as an operating discipline rather than a one-time build. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928312597/en/ Graphic: Xsolla Three themes run through the report. First, the gap between a typical Web Shop and a top-performing one is wide, and closing it has little to do
Incognito Software Systems Launches NEXA, an AI-Enabled Solution for Automated Broadband Operations28.9.2026 15:00:00 CEST | Press release
NEXA unifies network, device, service, and subscriber data to help broadband service providers identify issues earlier, improve customer experience, reduce churn, and automate operations. Incognito Software Systems, a leading global provider of service orchestration, device management, and network intelligence solutions, today introduced NEXA, an AI-driven network intelligence and automation platform that enables broadband service providers to turn operational data into action. NEXA unifies network, device, service, and subscriber data in a single intelligence layer, delivering real-time and predictive insights that help service providers identify issues sooner, better understand the subscriber experience, and take faster, more informed action across their operations. As service providers seek to differentiate beyond connectivity, subscriber experience has become a critical competitive advantage. However, networks have evolved into complex service platforms that span access, edge, cust
Volante Technologies and Circle advance stablecoin payment and settlement capabilities for financial institutions28.9.2026 15:00:00 CEST | Press release
Collaboration enables banks to integrate USDC workflows within existing multi-rail payments infrastructure Volante Technologies, the global leader in Payments as a Service (PaaS), today announced a strategic collaboration with Circle Internet Group, Inc. (NYSE: CRCL) (“Circle”), a leading internet financial platform company and the issuer of USDC1 through its regulated entities, to help financial institutions integrate stablecoin payment and settlement capabilities into their existing payment operations. Through the collaboration, Volante is bringing USDC workflows into its AI-powered Payments Platform, enabling financial institutions to evaluate how stablecoin activity can operate alongside existing payment rails, operational controls, and on- and off-ramp requirements - without requiring a separate digital asset stack. Volante clients, which include four of the top five global corporate banks and seven of the top 10 U.S. banks, will be able to evaluate key workflows, including mintin
Zayed Sustainability Prize Unveils 2027 Finalists Following Record-Breaking Global Entry28.9.2026 14:47:00 CEST | Press release
Record 10,233 submissions from 177 countries, up 32% year-on-yearFinalists are delivering practical, scalable solutions across health, food, energy, water and climate actionPrize has positively impacted more than 411 million lives worldwide From AI that can predict pregnancy complications months in advance and robots that navigate water networks, to new technologies restoring degraded soil and heat-resilient corals rebuilding reefs, the Zayed Sustainability Prize has unveiled its 2027 finalists following the most competitive cycle in its history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928805335/en/ Members of the Zayed Sustainability Prize Jury gathered in Abu Dhabi to determine the 2027 winners and finalists (Photo: AETOSWire) A record 10,233 submissions from 177 countries were received for the 2027 cycle, a 32% increase year-on-year, reflecting the growing global reach of the UAE’s pioneering award for innovativ
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom