Medicago submits Phase 3 data to Health Canada for its plant-based COVID-19 vaccine candidate
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/.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005780/en/
Contact information
Medicago media contact (English):
Tanvir Janmohamed (North America)
+1 613 404 3611 (Toronto)
media.en@medicago.com
Gabby Koumis (UK/Global)
+44 (0) 78 3328 6784 (London)
media.en@medicago.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
flatexDEGIRO Starts Into Expected Record Year 2024 With a Jump in Revenues and Earnings25.4.2024 21:19:00 EEST | Press release
flatexDEGIRO starts into expected record year 2024 with a jump in revenues and earnings Revenues increased by 25% to € 123 million (Q1 2023: € 98 million) flatexDEGIRO benefits from both rising interest income and a significant increase in commission income per transaction EBITDA improves by 177% to € 54 million (Q1 2023: € 19 million) Consolidated net profit increases by 340% to € 30 million (Q1 2023: € 7 million) 121,000 new customer accounts in Q1 2024 increase customer base to over 2.8 million (March 2023: 2.5 million) Net cash inflows of € 1.8 billion in Q1 2024 Revenues and consolidated net income in 2024 expected to be at the upper end of the guidance corridor (revenue growth of 5-15% and increase in consolidated net income of 25-50%) For the first time, the Management Board and Supervisory Board will propose to the upcoming Annual General Meeting the authorization to buy back up to 10% of the share capital as well as an additional dividend of 4 cents per share Dr. Benon Janos,
OpenGate Capital Completes Sale of SMAC25.4.2024 20:14:00 EEST | Press release
OpenGate Capital (“OpenGate”), a global private equity firm, announced today that it has completed the sale of SMAC, a provider of waterproofing and building envelope systems, to Compagnie Financière Jousset (“CFJ”) and the SMAC management team. Terms of the transaction were not disclosed. SMAC was established in 1884 and has grown into a leader in the French waterproofing and facades market. OpenGate acquired the business in 2019 from Colas Group, a subsidiary of Bouygues SA. Following the carve-out and stabilization of SMAC in the first year of investment, OpenGate embarked on a three-prong approach to sell the manufacturing (“Industrie”) business lines in 2020 and 2021 and achieved the following results: March 2021: Axter (membranes business) was sold to IKO April 2021: Skydôme (skylights business) was sold to Kingspan January 2022: Résipoly (resins business) was sold to MAPEI After the disposals of the Industrie business lines, SMAC was then able to focus on its core “Travaux” (ins
Farcana Announces Gateway: Showdown - Playtest Kicks Off April 30th, with a 1,000,000 $FAR token prize pool!25.4.2024 18:40:00 EEST | Press release
Farcana, a highly anticipated competitive, team-based hero shooter, announces Gateway: Showdown, a public playtest event taking place from April 30th to May 4th, 2024. This playtest serves as a crucial opportunity for Farcana to gather valuable player feedback, showcase the latest iteration of the game before its official launch and offer players a chance to claim a portion of the 1,000,000 $FAR token prize pool. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240425936808/en/ Farcana Announces Gateway Showdown - Playtest Kicks Off April 30th, with a 1,000,000 $FAR token prize pool! (Photo: AETOSWire) Gateway: Showdown welcomes all aspiring heroes with a signup process designed for ease and accessibility. Players can visit the official Farcana website at https://www.farcana.com to download the game client, create an account, and be automatically enrolled in the playtest. Every match played during the event will contribute to
Antognolla at International Hospitality Investment Forum: Growing Interest in the Italian Market from Hotel Operators and Investors25.4.2024 17:39:00 EEST | Press release
Antognolla Resort & Residences joined world-class hospitality experts at the Hospitality Investment Forum EMEA (IHIF EMEA) on 15-17 April in Berlin. With over 2,500 attendees this year, IHIF EMEA remains one of the largest gatherings of industry professionals in the region. Hospitality experts and event participants reaffirmed the growing interest among hotel operators in Italy, evident from the number of prestigious international brands entering the Italian market. The hospitality market in the country is becoming more identity-driven, with the majority of hotel keys in the upscale and luxury category being branded. International operators are increasingly attracted to the country year by year: almost 70% of the properties in the pipeline will belong to international chains by 2026. Andrey Yakunin, Chairman of the Board of Directors of Antognolla Resort & Residences commented: “As international experts discussed during IHIF, identity-driven, branded projects are set to become the lead
Digital Transformation’s Next Era: Generative AI and Laserfiche 12 at 2024 Empower Conference25.4.2024 17:30:00 EEST | Press release
Preparing organizations for the next AI-driven phase of digital transformation is on the agenda at the 2024 Empower conference, hosted by Laserfiche — the leading SaaS provider of intelligent content management and business process automation — in Las Vegas through April 25. Laserfiche shines a spotlight on solutions that reduce complexity and accelerate information flow across the enterprise to help organizations manage increasing amounts of data. Empower attendees got an early look at the latest Laserfiche AI features, including Laserfiche AI Document Summarization. The new offering, powered by generative AI, eliminates tedious sifting through documents by generating concise summaries of documents containing either text or transcribed audio. Laserfiche AI Document Summarization, which represents one milestone in the Laserfiche AI vision to transform the workplace, will be available in the upcoming Laserfiche Cloud release on April 30, 2024. “At Laserfiche, we believe AI will impact p
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