Business Wire

Medicago and GSK Start Phase 3 Trial of Adjuvanted COVID-19 Vaccine Candidate

Share

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.

“We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world,” said Takashi Nagao, CEO and President of Medicago. “This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK.”

Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “This advance to late stage clinical testing further reinforces our confidence in the adjuvanted vaccine candidate’s potential to make a difference in the continued fight against COVID-19. We look forward to sharing results later this year.”

Medicago’s plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK’s pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart.

The vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the US Food and Drug Administration (FDA) on February 17, 2021. Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.

“The FDA’s decision to grant Fast Track designation for Medicago’s vaccine candidate will help us expedite our efforts to bring the first plant-derived COVID-19 vaccine to market, subject to regulatory approval,” said Carolyn Finkle, Chief Operating Officer of Medicago. “We are grateful to the FDA and look forward to continuing to work with them as we move forward in our clinical trials, planned application for Emergency Use Authorization, and eventual vaccine licensure application process.”

The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo. The study will enroll up to 30,000 subjects initially composed of healthy adults (18y to 65y), followed by elderly adults (65y+) and adults with comorbidities. The trial will take place in 10 countries pending regulatory approvals, starting with Canada and the United States, and will enroll males and females from ethnically and racially diverse populations.

Information about how to participate in this clinical trial is available at http://www.CoVLPvaccine.com.

The Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.

About Medicago

Medicago is on a mission to 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-derived therapeutics. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 450 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.

For more information: www.medicago.com

About GSK and its commitment to tackling COVID-19

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

Contact information

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

GSK enquiries:
Media enquiries:
Simon Steel
+44 (0) 20 8047 5502
(London)

Simon Moore
+44 (0) 20 8047 5502
(London)

Kathleen Quinn
+1 202 603 5003
(Washington, DC)

Analyst/Investor enquiries:
Sarah Elton-Farr
+44 (0) 20 8047 5194
(London)

James Dodwell
+44 (0) 20 8047 2406
(London)

Jeff McLaughlin
+1 215 751 7002
(Philadelphia)

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

CGTN: A City on the Rebound: How Hong Kong Can Move Forward13.4.2021 20:57:00 EEST | Press release

The past two years have been tough on the world, not just due to the pandemic but also the geopolitical volatility that has roiled many countries and regions. In East Asia, the financial hub of Hong Kong has experienced its fair share of difficulties, but as life slowly returns to normal, problems that have plagued the city for decades remain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413006039/en/ (Photo: Business Wire) The city's brief history is well-documented – its humble industrialization in the 1970s coupled with the entrepreneurial spirit of its residents saw it become a bastion of wealth at a time when that part of the world was still economically stagnant. Coupled with a liberalized financial system and generous policies, the city catapulted itself toward the top, competing with mega-cities such as London and New York City. For all its glitz and glamour, Hong Kong contained contradictions that boiled over i

Tigo Intellectual Property Infringement Lawsuit against APS Continues to Grow13.4.2021 20:53:00 EEST | Press release

Tigo Energy, Inc., the solar industry worldwide leader in Flex-MLPE (Module Level Power Electronics), has filed a new lawsuit against Altenergy Power Systems (“APsystems”), in addition to its current ongoing case. The complaint includes four new patent infringement claims, as well as an additional claim from a patent asserted in the previously-filed lawsuit. The complaint was filed in the United States District Court for the Northern District of California. The total number of Patents-in-Suit in both cases now stands at six. The complaint includes all APsystems legal entities in the US as well as in China. The new complaint alleges that APsystems’ Sunspec-compliant products infringe the following U.S. patents: 8,653,689, 9,584,021, 9,966,848, 10,333,405, and 8,933,321. The complaint centers around various systems and methods used in the PV module rapid shutdown unit. Tigo’s industry leading solar equipment provides optimized, monitored and safe solar to protect this critical infrastruc

Maxon Announces Cinema 4D S2413.4.2021 19:05:00 EEST | Press release

Maxon, the developers of professional software solutions for motion designers and visual effects artists, today announced Cinema 4D Subscription Release 24 (S24). The latest subscription-only release of Maxon’s 3D application allows users to easily browse and obtain models, materials and other assets, and to intuitively place them within the scene. The release also includes key workflow enhancements and a sneak peek at continued progress on the Scene Nodes and Scene Manager interfaces to the new core. Cinema 4D S24 is immediately available for subscription customers. For perpetual license holders of Cinema 4D a release is scheduled later this year that will incorporate the features of S24, as well as future enhancements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005918/en/ Maxon Cinema 4D S24 features placement tools, a new asset browser, animation workflow enhancements, and continued development on powerful nodes

Maxon Announces Redshift for macOS Including Native Support for M1-Powered Macs13.4.2021 19:05:00 EEST | Press release

Today, Maxon announced the immediate availability of Redshift for macOS including support for M1-powered Macs as well as Apple’s Metal Graphics API. Redshift, the award-winning, production-ready renderer, offers a rich feature set including ray switches, flexible shading networks, motion blur, AOVs, deep output, layered EXR and much more. Unlike other GPU renderers, Redshift is a biased renderer that enables artists to adjust the quality of individual techniques in order to get the best performance/quality balance for production. As a Universal solution, Redshift is optimized for high-end performance across both M1- and Intel-powered Macs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005903/en/ Redshift for macOS signifies a milestone, bringing cutting-edge cinematic rendering to Mac artists. (Graphic: Business Wire) Redshift for macOS signifies a milestone, bringing cutting-edge cinematic rendering to Mac artists. A

Golden Euro -pelaaja voitti ennätyksellisen 3 miljoonan euron jättipotin13.4.2021 18:29:00 EEST | Tiedote

samppanja on virrannut ja juhlat ovat olleet käynnissä Golden Euro -kasinolla sen jälkeen, kun onnekas pelaaja voitti jackpotin ja sai jättimäisen 3 746 291 € voiton. Pelaajan voitto irtosi Realtime Gamingin valtavan suositusta Aztec Millions -kolikkopelistä, ja se on suurin koskaan progressiivisesta jättipottipelistä ja Golden Euro -kasinolta voitettu voitto. Peli-istuntonsa alussa 49-vuotias pelaaja teki 27 € luottokorttitalletuksen ja lunasti Golden Euron rakastetun 50 % talletusbonuksen, joten hänellä oli pelikassassaan 54 €. Voiton toi pieni 5 € yksittäispanos, jonka hän asetti älypuhelimellaan. Kun rullat pysähtyivät ja jättipotti käynnistyi, panos teki pelaajasta välittömästi monimiljonäärin. Golden Euro -kasinon Adrian Berger sanoi: ”Olemme niin iloisia, että yksi pelaajistamme on saanut suurimman jättipottivoiton koskaan Realtime Gamingin Aztec Millions -pelistä. Puhuin pelaajan kanssa pian hänen voittonsa vahvistamisen jälkeen, ja hän oli todella innoissaan, vaikkei hän vielä

Agthia Embarks on Transformational Journey with its Strategy to Become an F&B Leader by 202513.4.2021 18:06:00 EEST | Press release

Agthia Group PJSC revealed its long-term strategy to become an F&B leader in the Middle East, North Africa and Pakistan (MENAP) region and beyond by 2025. The strategy is built on three strategic pillars (growth, efficiency and capability) and is designed to extend the Group’s market leadership, provide significant value for all stakeholders and continue to drive profitability growth with a consumer-centric approach. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005841/en/ Khalifa Sultan Al Suwaidi - Chairman - Agthia Group (Photo: AETOSWire) The Abu Dhabi-based organisation is engaged in manufacturing, distribution and marketing of a wide range of F&B products, including popular regional brands such as Al Ain (water), Al Foah (dates), Al Faysal Bakery & Sweets (bakery) and Grand Mills (flour and bakery) among others. Khalifa Sultan Al Suwaidi, Chairman, Agthia Group, said: “The strategy will unleash the full potentia

FRISS Acquires Terrene Labs to Expand Underwriting Efficiency13.4.2021 18:03:00 EEST | Press release

FRISS, the market leader in AI-powered fraud, risk and compliance solutions for P&C insurance carriers, today announced the acquisition of Terrene Labs. Industry leaders in providing Commercial Insurance providers with comprehensive Risk Insights, Terrene will be a fundamental addition to the FRISS product family. Commercial lines underwriters now have access to thousands of actionable insights within just 5 seconds, replacing a disjointed manual and limited enrichment process that previously took up to a week and delayed policies for quality customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210413005837/en/ FRISS acquires Terrene Labs and welcomes them to their family. (Graphic: Business Wire) “We’re bringing commercial lines to the digital age together,” remarked FRISS CEO and Co-founder Jeroen Morrenhof. “True risk insights were always hard to access and we’re changing that. Combined with the analytics capabilitie

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