Business Wire

Medicago Announces Positive Phase 1 Results for Its COVID-19 Vaccine Candidate

Share

Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to report interim results of the Phase 1 clinical trial of its plant-derived vaccine for COVID-19. The results of the trial demonstrated that 100 per cent of subjects developed a promising antibody response after two doses of Medicago’s COVID-19 adjuvanted vaccine candidate.

“These are very promising results. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses which is encouraging and support further clinical evaluation,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago. “We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease.”

There were no severe adverse events reported and reactogenicity events were generally mild to moderate and short in duration.

The Phase 1 clinical trial was a randomized, partially blinded study of 180 healthy subjects, male and female aged 18-55, and evaluated dosages of 3.75, 7.5 or 15 micrograms of the recombinant Coronavirus Virus-Like Particle (CoVLP) vaccine candidate alone or with an adjuvant in a prime-boost regimen. Medicago tested its vaccine candidate with each of the two adjuvants – GSK’s proprietary pandemic adjuvant technology and Dynavax’s CpG 1018™. An adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore allowing immunization of the greatest number of people. Significant humoral and cell-mediated immune responses have been observed with both adjuvants. Based on the Phase 1 data, Medicago plans to proceed with the Phase 2/3 clinical trial for its COVID-19 vaccine candidate, subject to regulatory approval.

“The positive results of our Phase 1 clinical trial are a step forward in the fight against the COVID-19 pandemic and we are confidently moving forward to our Phase 2/3 trial. We’re pleased that Medicago’s innovative manufacturing technology is helping to diversify the classes of COVID-19 vaccines candidates in development. In addition to supplying up to 76 million doses to the Government of Canada, we are ready to participate globally in the fight against COVID-19,” said Dr. Bruce D. Clark, President and CEO of Medicago. “We would like to express our gratitude to the clinical trial participants who have generously dedicated their time to support the advancement of Medicago’s COVID-19 vaccine candidate. We also would like to extend our thanks to our partners GSK and Dynavax, as well as the clinical investigators.”

The data from the interim analysis have been published on an online preprint server at medRxiv.org.

About Phase 1 results summary

  • Side effects were mainly mild to moderate and of short duration with no serious adverse events. Safety follow-up continues.
  • Phase 1 immunogenicity results demonstrate that adjuvants have the potential to improve humoral and cellular immune responses compared to the non-adjuvanted formulations.
  • All subjects in the group with GSK’s pandemic adjuvant developed anti-spike IgG antibodies after a single dose of vaccine – either 3.75, 7.5 and 15 µg.
  • 100 per cent of participants who received an adjuvanted formulation developed neutralizing antibody responses after Dose 2 for all dose groups.
  • Anti-spike IgG and viral neutralization responses compared favorably to responses from COVID-19 positive patients outside of the study.
  • GSK’s pandemic adjuvant was dose-sparing, with the lower 3.75 µg dose of CoVLP performing comparably with the 7.5 or the 15 µg doses.
  • Cellular Th1 immune responses of participants who received 3.75 or 7.5 µg doses were significantly higher in the adjuvanted formulations
  • CoVLP finished product is a liquid formulation that can be stored at 2°C to 8°C, easing cold chain management with existing vaccine infrastructure.

About Medicago

Medicago is a biopharmaceutical company and pioneer in plant-derived therapeutics. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.

Our mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global healthcare challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide. Our team includes over 450 scientific experts and employees in Canada and the United States and academic affiliations in Europe and South Africa.

Medicago has previously demonstrated its capability to be a first responder in a flu pandemic. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. In 2012, Medicago manufactured 10 million doses of a monovalent influenza vaccine candidate within one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense. In 2015, Medicago also demonstrated in principle that it could rapidly produce an anti-Ebola monoclonal antibody cocktail for the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

For more information:www.medicago.com

To learn more about our plant-based technology: Video / Website

Contact information

Media contact (English):
Alissa Von Bargen
+1-647-234-5975
Alissa.VonBargen@gcicanada.com

Media contact (French):
Marie-Pier Côté
+ 1-418-999-4847
mpcote@tactconseil.ca

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Luxembourg to Start Real Life Testing of an International Standard for a Digital Circularity Fingerprint for Products27.11.2020 12:00:00 CETPress release

The Ministry of the Economy of Luxembourg just launched phase two of the development of an international standard. It provides information on the circularity of products to all stakeholders involved along their value chains. A first viable version of the standard is being tested in real life, allowing to identify the most suitable governance model, the audit scheme and reliable IT systems for its management. Luxembourg started the Circularity Dataset Initiative in 2018 to address the difficulty for industry and consumers to access reliable data on the circular properties of a product. A lot of circularity information is missing, as its generation and handling requires too many human and financial resources. Furthermore, trade secrets are hindering transparency and reporting standards are lacking, forcing manufacturers to send out different data sets in diverse formats to customers and product platforms. To tackle these challenges, the Luxembourg government is working with multinational

Chengdu Continues to Enhance Trade Links and Cultural Exchanges to Expand Circle of Friends Around the World27.11.2020 10:24:00 CETPress release

The Chengdu-Europe railway line spans over 10,000 kilometers across countless rivers and mountains, transporting goods to vast numbers of people across the Eurasian landmass. With increased trade, cultural links between Chengdu and Europe are also growing stronger. Against this backdrop, Chengdu-Eurasia National Pavilion Cluster (CENPC) has emerged in the Qingbaijiang District of Chengdu to further promote trade and cultural exchanges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005270/en/ Head of CENPC’s pavilion for France and the Netherlands Xu Dandan at work (Photo: Business Wire) CENPC is an important platform for trade exhibition and cultural exchange between countries along the Belt and Road. With trade promotion as a foundation, the project, which is expected to feature over 40 national pavilions, aims to deepen Sichuan’s global cooperation in fields such as culture, talent, education, and science and techno

Chengdu-Europe Railway Adds Momentum to Chengdu's Rise as an International Hub, Leading to Closer Cooperation Between Chengdu and Tilburg27.11.2020 10:14:00 CETPress release

Chengdu in China's Sichuan Province and Tilburg in The Netherlands, the two cities at the opposite ends of the Eurasian landmass, are now closely connected via an intercontinental railway that spans nearly 11,000 kilometers. In a recent interview with Xinhuanet, Roland Verbraak, general manager of GVT Group of Logistics - the Dutch partner of the Chengdu-Europe Railway, praised: "Not only are our relationships with Chinese partners getting closer, but the two cities of Chengdu and Tilburg have also become sister cities. Chengdu's international development is progressing well at a rapid pace." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201127005267/en/ Roland Verbraak, general manager of GVT Group of Logistics (Photo: Business Wire) Goods shuttling along the Chengdu-Europe Railway line have not only spurred economic growth in China and The Netherlands but also deepened links between Chengdu and places along the route, add

REPLY: Reply enters into eSports27.11.2020 09:00:00 CETPress release

Reply, on the eve of Milan Games Week, announces its entry into eSports in collaboration with Totem eSports, a project born in 2019 that spent the year battling its way through the most competitive titles of the main ESL circuits, which for the 2021 season will be renamed Reply Totem eSports. The Reply Totem eSports team, thanks to the experience gained by its young talents at national and international level, will compete in the next season in the ESL EVC circuits on the mobile titles including Clash Royale, Brawl Stars and on a series of other titles, ranging from sports such as FIFA to FPS and strategic cards. Reply's entry into eSports is part of a wider range of initiatives aimed at supporting young technology enthusiasts. With this collaboration, Reply, which already operates in the gaming sector with Game Studio and B2B initiatives, enters a market in continuous growth, that symbolizes the impact of digitalization in all sectors. Filippo Rizzante, Reply's CTO, commented: "The eS

Vertex Announces European Commission Approval for SYMKEVI ® (tezacaftor/ivacaftor) With KALYDECO ® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years27.11.2020 09:00:00 CETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension for SYMKEVI® (tezacaftor/ivacaftor) with KALYDECO® (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. “With this approval, children with CF in Europe ages 6 to 11 years with the most common mutation, F508del, have a new treatment option and children with certain residual function mutations will, for the first time, have a treatment option available that addresses the underlying cause of their CF,” said Reshma Kewalramani, M.D., Chief Executive O

Thales to Deliver the World’s First Fully Integrated Unmanned Mine Countermeasures System for the Royal Navy and French “Marine Nationale”26.11.2020 20:55:00 CETPress release

Following the first phase of the program in which two demonstrators have successfully proven their operational performances at sea, France and the United Kingdom marked the tenth anniversary of the Lancaster House treaties by signing a joint contract for Thales to start the production phase of MMCM to deliver eight unmanned mine hunting systems (four for France and four for the United Kingdom). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005783/en/ MMCM system at sea ©Thales With the threat of mines and improvised explosive devices present in all conflicts involving naval forces, countries need to strengthen the protection of their maritime domain, to ensure the protection of their assets and to safeguard the freedom of civil navigation. At the same time, it is essential to limit human exposure to mines. With 50 years of expertise serving navies around the world, Thales develops technologies that enable the transiti