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
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Elliptic Launches Market Intelligence Unit and Announces New Proposition for Crypto Traders17.1.2022 12:10:00 CET | Press release
Elliptic, the leading provider of on-chain blockchain analytics, today announces the launch of its market intelligence unit; a second line of business for the organization that is focused on leveraging Elliptic’s best-in-class identity graph to build new propositions and use cases for businesses trading crypto. The new unit, led by Elliptic co-founder James Smith and Laura Coffey, will harness Elliptic’s dataset as an intrinsically valuable data layer for the burgeoning institutional crypto trading market. The data will provide access to the broadest asset coverage of on-chain identity metrics in the industry, allowing traders to: Forecast: Utilize real insights behind the movements of money to access fundamental activity metrics for a wide range of cryptoassets React: Profile the different types of actors behind deposits, withdrawals and other transactions in real-time to assess the motivations behind market-moving activity Analyze: Explore flows between businesses and other types of
38% of Supplier Survey Respondents Use Early Payment to Manage Working Capital, Up From 19% In 201717.1.2022 11:00:00 CET | Press release
38% of respondents take early payments monthly in 2021, up from 19% in 2017, according to a supplier sentiment survey conducted by Taulia, the leader in working capital technology solutions. Taulia’s global supplier sentimentsurveyhas been conducted annually since 2017 and reflects the views of nearly 80,000 respondents over a five-year period. There has been growing interest from suppliers in regularly receiving early payment once an invoice is approved as an alternative source of finance. In 2021, one-fifth (22%) of suppliers were interested in receiving early payment every time for every customer, compared to 15% in 2017. The supplier's reasons for taking early payments varied. In 2021, the main reasons for their interest in early payments were*: Cash flow gap (49%) Collections/payment predictability (27%) Working capital needs (21%) Ease of use (18%) Reduce DSO (7%) There is also a clear progression towards better behaviour from businesses with a welcome decrease in late payment, w
Gunma Prefecture's Geographical Indication “GI Tone-Numata” Sake Kicks Off Its Overseas Sales on January 17!17.1.2022 09:00:00 CET | Press release
Sake’s geographical indication, “GI Tone-Numata,” which consists of four sake breweries in the Tone-Numata area of Gunma Prefecture in Japan, requires that the breweries make the most of the local water and climate, and that the type of rice used as the raw material be one of the following: Yukihotaka, Gohyakumangoku, or Koshihikari. In addition, only yeast from the local area (Gunma KAZE yeast, Gunma G2 yeast, and brewer's house yeast) can be used, and vintage can be indicated under certain conditions, so only those that meet the extremely strict criteria are certified. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220111006144/en/ 7 types of GI Tone-Numata certified sake (Photo: Business Wire) According to Mr. Shinya Tasaki, Chairman of the Japan Sommelier Association, "GI Tone-Numata is equivalent to PDO in Europe or AOC in French wine and is expected to attract worldwide attention in the future." On January 17, "GI Tone
EcoFlow Launches the DELTA Pro, its Pioneering Portable Power Station, in Europe17.1.2022 08:00:00 CET | Press release
EcoFlow, a portable power and renewable energy solutions company, has launched the industry-leading DELTA Pro portable home battery in Europe. Originally a Kickstarter campaign, it smashed records to become the most-funded tech project at the time and still ranks sixth among all projects to date. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005003/en/ EcoFlow DELTA Pro Portable Home Battery (Photo: Business Wire) With a base capacity of 3.6kWh and expandable to 25kWh, the DELTA Pro is the industry’s first portable home battery and can provide multiple days’ worth of backup energy to families in the case of emergencies. In September 2021, EcoFlow launched the DELTA Max and the DELTA mini in Europe, both of which are designed to offer backup power for shorter blackout periods. “DELTA Pro’s highly successful Kickstarter campaign overwhelmingly demonstrates the consumer desire for portable clean energy power and storage
TaiwanPlus Features Namewee and ABAO’s Music-Creation Journey on Its Indie Music Docuseries, “Road to Legacy”17.1.2022 07:51:00 CET | Press release
TaiwanPlus, a new global English-language video streaming platform, launches a 2022 TaiwanPlus Original Series titled “Road to Legacy,” which is a 10-episode docuseries detailing the journey to fame of these 10 bands in Taiwan. On January 17, 2022, TaiwanPlus holds the world premiere at Legacy Taipei, with the docuseries launched exclusively and free to stream worldwide via www.TaiwanPlus.com on the same day. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005075/en/ The TaiwanPlus Original Series will be released in three installments, kicking off with the episodes on Tizzy Bac, 88BALAZ and Nighteentael on January 17th. (Graphic: Business Wire) Since its inception, “TaiwanPlus strives to provide a platform to showcase the diverse, creative culture that flourished under Taiwan’s vibrant democracy. Following the positive reception from the TaiwanPlus Film Festival, which was an online curation of 10 iconic Taiwanese film
Seoul Semiconductor Proves the Effect of SunLike Lighting on Myopia Improvement17.1.2022 06:16:00 CET | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ 046890), a global optical semiconductor company, announced on the 17th that it has confirmed SunLike lighting’s effect on improving myopia, along with SERI_Singapore Eye Research Institute. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220116005060/en/ Experimental results on the correlation between lighting and myopia, conducted by Seoul Semiconductor and Singapore Eye Research Institute (Graphic: Business Wire) In order to prove the correlation between health and SunLike, a natural lighting technology developed through years of R&D, Seoul Semiconductor has been conducting experiments with Seoul National University, Basel University, and Harvard University since 2017. This time, with Singapore SERI, the effect of natural lighting on myopia improvement was tested. In this experiment, chicks, whose eyes are similar to humans’, were exposed to different lightings and then the length of th
Megaport Announces Expansion to Mexico, Bringing Network as a Service (NaaS) and Direct Access to Leading Cloud Services to KIO Networks16.1.2022 22:00:00 CET | Press release
Megaport Limited (ASX: MP1) ("Megaport"), a global leading Network as a Service (NaaS) provider, today announces plans to expand services to Mexico via a partnership with KIO Networks, the country’s largest data centre provider. Cloud connectivity services to Microsoft Azure and Google Cloud are expected to be available in March 2022 to local enterprises via on-ramps from KIO Networks’ data centres in Mexico City and Queretaro, subject to approvals. Customers of KIO Networks in Mexico will be able to access Megaport’s leading ecosystem of more than 700 enabled data centres worldwide and over 360 service providers, including 230+ cloud on-ramps from the world's leading clouds such as AWS, Google Cloud, Microsoft Azure, IBM Cloud, and Oracle Cloud. Businesses in Mexico can seamlessly and directly connect to cloud and IT services on a global level without the need to manage complex network infrastructure. According to IDC, Mexico is the second largest market in Latin America when it comes