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
GIGABYTE Powers Telecom AI Transformation with End-to-End Infrastructure at MWC 20262.3.2026 02:00:00 CET | Press release
From AI factories and supercomputing to digital twins, cloud hosting, and edge AI, GIGABYTE enables telecommunications operators to turn network data into intelligence, automation, and new revenue streams. GIGABYTE Technology, a global leader known for its engineering excellence in high-performance computing and AI servers, extends its comprehensive end-to-end AI infrastructure portfolio designed specifically for the telecommunications industry at MWC 2026. GIGABYTE’s end-to-end product solutions enable operators to convert massive volumes of network data into intelligence, automation, and new revenue streams, as telecommunications networks evolve from data carriers into AI-powered digital platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223386188/en/ GIGABYTE Powers Telecom AI Transformation with End-to-End Infrastructure at MWC 2026 From Network Data to AI Value: Building Telco’s AI Factory At the core of the t
Lenovo Unveils Adaptive AI PCs, Modular Concepts, and Lenovo Qira Rollout at MWC 20262.3.2026 00:01:00 CET | Press release
From modular business computing and glasses-free 3D to foldable gaming and system-level AI, Lenovo advances Smarter AI for All At MWC® 2026, Lenovo™ introduces a new generation of adaptive AI devices and forward-looking concepts designed for business professionals, creators, students, and gamers. Headlined by new modular PC architecture, a glasses-free 3D laptop concept, a foldable gaming handheld device, and the initial rollout of Lenovo Qira, Lenovo’s showcase reflects a broader shift in personal computing toward systems that adapt intelligently to people and their environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301217460/en/ Across its portfolio, Lenovo continues to focus on delivering technology that is more personalized, proactive, and protected, while building a unified AI ecosystem that works naturally across devices. “The AI era will not be defined by a single device or application, but by intelligent
TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing1.3.2026 07:00:00 CET | Press release
As MWC Barcelona 2026 highlights the growing role of AI, connectivity, and smarter technology systems, the mobile accessories market is entering a new phase defined by speed and complexity. Product categories continue to expand, designs and styles update faster, and retailers are expected to respond to market changes in shorter cycles. Keeping product lines up to date while managing sourcing efficiently has become a real challenge for retailers and distributors across Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121405485/en/ TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing At MWC Barcelona 2026, TVCMALL highlights its role as a leading one-stop mobile accessories wholesaler in Europe, with a clear focus on making wholesale and sourcing easier, faster, and more reliable. With more than 18 years of experience, TVCMALL works closely with 30+ leading retail partners across Europe, supp
Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE03428.2.2026 01:00:00 CET | Press release
IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in combination with IDEAYA’s PARG inhibitor IDE161. IDEAYA has dosed the first patient in its Phase 1 trial of IDE034, initially evaluating safety, tolerability, and PK. First dosing triggers a $5 million milestone payment to Biocytogen under the companies’ option and license agreement. Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million
IQM and Real Asset Acquisition Corp. to Host Conference Call/Webcast to Discuss Proposed Transaction27.2.2026 13:00:00 CET | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced that they will host a conference call to discuss their recently announced business combination, including certain transaction highlights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227472716/en/ IQM Radiance quantum computer As previously disclosed, on February 23, 2026, IQM and RAAQ announced they have entered into a definitive business combination agreement, which will result in IQM becoming a public company and listing American Depositary Shares on one of the two leading U.S. stock exchanges. The transaction provides funding with the aim to accelerate IQM’s technology and commercial development towards fault-tolerance quantum computing, further advancing its position as a leading 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