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
NetApp Acquires DataPelago, Making Data AI-Ready at the Infrastructure Layer16.7.2026 18:30:00 CEST | Press release
Embedding GPU-accelerated intelligence enables enterprises to easily discover, govern, and activate data for AI and analytics at the source NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced it has acquired DataPelago, a California-based AI data infrastructure company recognized for its innovative approach to eliminating data processing bottlenecks for AI and analytics workloads. The acquisition marks a foundational expansion of NetApp's portfolio, enabling GPU-accelerated data processing aligned directly with the storage layer. With this acquisition, NetApp establishes itself as the company that makes zero-copy activation of enterprise data for AI real. AI is the defining platform shift of our era, but enterprises are discovering that their greatest bottleneck is preparing, governing, and activating their data fast enough to put AI into production. The key to accomplishing this objective is to enable accelerated computing where the data is created and
Visa Introduces Platform for Stablecoin Minting, Movement and Management16.7.2026 16:30:00 CEST | Press release
The Visa Stablecoin Platform gives financial institutions, fintechs and other payment providers a single environment to come onchain and run stablecoin operations with Visa. Today, Visa (NYSE: V) announced the Visa Stablecoin Platform (VSP), a new enterprise platform designed to help financial institutions, fintechs, and crypto natives access stablecoin capabilities through a single Visa-managed environment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716292689/en/ Building on Visa’s broader crypto strategy, VSP gives FIs, fintechs and other payment providers a simple way to access, store, and redeem stablecoins, beginning with Open USD (OUSD), a new stablecoin recently introduced by Open Standard. This includes onchain wallet infrastructure through a newly introduced Wallet-as-a-Service offering and connectivity for minting and burning Open USD. “Stablecoins are opening up a new layer of programmable money, but for mo
Cyclic Materials Appoints Tomasz Poznar as Chief Commercial Officer to Accelerate Global Commercial Growth16.7.2026 15:20:00 CEST | Press release
Industry leader in critical materials and battery recycling to drive Cyclic’s global commercial growth and strategic partnerships. Cyclic Materials, the rare earth recycling company building a circular supply chain for rare earth elements and critical materials, today announced the appointment of Tomasz Poznar, Ph.D., as Chief Commercial Officer. The appointment strengthens Cyclic Materials’ executive team as the company accelerates commercial expansion across North America, Europe, and Asia. Most recently, Poznar served as Chief Commercial Officer at Ascend Elements, where he led the company’s global commercial strategy, strategic partnerships, and business development. During his tenure, he helped secure more than USD $1.5 billion in commercial agreements, including a landmark USD $1 billion supply agreement with a major global automaker, while also supporting approximately USD $320 million in TCTF government funding that accelerated the company’s growth in North America and Europe.
Modon Holding and Nammos Hotels & Resorts Bring Nammos Ras El Hekma to Egypt’s North Coast16.7.2026 14:50:00 CEST | Press release
Developed in partnership with Nammos Hotels & Resorts, the landmark Mediterranean destination will bring together branded residences, a luxury resort, restaurant and beach club, retail village, and signature dining and wellness experiences to Egypt for the first time. Abu Dhabi-based Modon Holding and Nammos Hotels & Resorts have announced Nammos Ras El Hekma – the renowned lifestyle and hospitality brand’s first fully integrated destination in Egypt. Located within the Wadi Yemm precinct, the development will bring Ras El Hekma’s promise of timeless Mediterranean living to life, combining Nammos Residences, Nammos Resort, Nammos Village, and a curated selection of all-day dining and wellness experiences, including the globally renowned Nammos Restaurant & Beach Club. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716740934/en/ Modon Holding and Nammos Hotels & Resorts bring Nammos Ras El Hekma to Egypt’s North Coast (Pho
Tridiagonal.ai (T.AI) Partners with PETRONAS Carigali’s TriCipta AI with IBM to Advance Engineering Domain-Driven AI Solutions for Upstream Operations16.7.2026 14:30:00 CEST | Press release
Tridiagonal.ai will contribute engineering domain-driven AI solutions, physics-informed models and Decision Intelligence capabilities to support upstream surface equipment optimisation, maintenance reliability and asset integrity decision workflows. Tridiagonal.ai Pvt. Ltd. (T.AI), the dedicated AI arm of Tridiagonal Group, announced its role in the third Joint Development Agreement (JDA) involving PETRONAS Carigali Sdn. Bhd. and IBM Malaysia Sdn. Bhd. to advance PETRONAS Carigali’s flagship TriCipta AI across the Upstream value chain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715579933/en/ Signing ceremony for the third TriCipta AI Joint Development Agreement, attended by executives from Tridiagonal.ai (T.AI), PETRONAS Carigali, and IBM Malaysia. TriCipta AI is PETRONAS Carigali’s partnership model that combines deep domain technical expertise with advanced AI technology experts to accelerate the development and dep
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