Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted COVID-19 Vaccine Candidate
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to report positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago’s plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant. These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing. Immunogenicity, as measured by the neutralizing antibody titer, was high - about 10 times higher than those in a panel of sera from patients recovering from COVID-19. No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.
“We are very excited to see such positive results from the Phase 2 data. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago. “These results give us confidence as we continue to move forward with our Phase 3 clinical trial. We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide.”
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “We are delighted to see that the results suggest a very strong immune response. Medicago’s COVID-19 vaccine candidate, combined with GSK’s pandemic adjuvant, was also well tolerated, reinforcing its potential benefits. We now look forward to the outcome of the ongoing Phase 3 trial of the refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic.”
The Phase 3 trial of the vaccine candidate launched on March 16, 2021. Trial sites are currently enrolling subjects in Canada, the United States, the United Kingdom, and Brazil, with additional sites expected to be added in the coming weeks. The vaccine candidate has received Fast Track designation by the FDA in the United States, and Health Canada has initiated a review of Medicago’s COVID-19 rolling submission under the Interim Order.
About Phase 2: Results Summary
The interim data from the Phase 2 trial in adults and in the elderly have been published on an online preprint server at MedRxiv.
- This publication focuses on presenting safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-γ and IL-4 ELISpot) responses, in Adults aged 18-64 (Adults) and Older Adults aged 65+ (Older Adults).
- Medicago’s vaccine candidate with GSK’s pandemic adjuvant exhibited an acceptable safety profile and adverse events (AE) were primarily mild or moderate and of transient duration.
- AEs in Older Adults were more limited than those observed in the Adult population.
- Medicago’s vaccine candidate with GSK’s pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses.
- The vaccine candidate induced a greater humoral response in Adults than Older Adults after a single dose but after the second dose both age cohorts responded with NAb titers that were about 10 times higher than those in a panel of sera from patients recovering from COVID-19.
About the Phase 2/3 study
The Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK's pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities.
The Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It was conducted in multiples sites in Canada and the United States on a population composed of healthy adults (18-64y), elderly adults (over 65y) and adults with comorbidities. Each age group enrolled up to 306 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate which will be the final analysis.
The Phase 3 portion is an event-driven, randomized, observer-blinded, crossover placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in up to 30,000 subjects in North America, Latin America and Europe and within the same population.
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 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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Medicago media contact (English):
Alissa Von Bargen (North America)
+1 647 234 5975 (Toronto)
Gabby Koumis (UK/Global)
+44 (0) 78 3328 6784 (London)
Simon Steel +44 (0) 20 8047 5502 (London)
Simon Moore +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003 (Washington DC)
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
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
Ezbob Introduces New SaaS Platform to Meet the Changing Landscape of Digital Banking21.6.2021 11:00:00 CEST | Press release
Ezbob Ltd., an innovator in customer acquisition technology for financial services, today announced the introduction of a new modular SaaS platform that addresses key trends in the sector. The company’s Ezbob Express™, focuses on three important needs: offering financial service providers the flexibility of filling gaps in their digital transformation strategies, enabling them to make more precise complex credit and risk decisions in real-time, and facilitating the growth of embedded finance. Ezbob’s new Express customer acquisition platform has a modular approach, enabling financial institutions with gaps in their digital channel to add the functionality needed to achieve a customised digital experience. The new modules include: UX & Process Design, Compliance & Authentication, Credit & Risk Decisioning and Product Recommender. Since its inception Ezbob has been providing digital onboarding services for many well-known financial institutions including Santander, NatWest, Metro Bank, P
Ambarella Expands Security AI Vision SoC Portfolio With Two New Families; Doubles Resolution to 32MP30 for 4K Multi-Imager Cameras With Advanced AI21.6.2021 11:00:00 CEST | Press release
Ambarella, Inc. (NASDAQ: AMBA), an AI vision silicon company, today announced the expansion of its AI vision SoC portfolio with the new CV5S and CV52S security families. Based on the CVflow® architecture and advanced 5nm process technology, the new SoCs support simultaneous 4K encoding and advanced AI processing in a single low-power design, which provides industry-leading edge AI SoC performance per watt. The CV5S family is ideal for security camera applications that require multiple sensors for 360-degree coverage, over a wide area and with a long range, such as outdoor city environments or large buildings. The CV52S family is designed for single-sensor security cameras with advanced AI performance that need to more clearly identify individuals or objects in a scene, including faces and license plate numbers over long distances, such as ITS traffic cameras. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210621005178/en/ Am
Jardiance ® (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction21.6.2021 10:36:00 CEST | Press release
The European Commission has granted marketing authorization for Jardiance® (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure), Boehringer Ingelheim and Eli Lilly and Company have announced.The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021.2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210621005298/en/ “Today’s approval provides an important new treatment option which can now help the millions of people in Europe living with symptomatic chronic heart failure with reduced ejection fraction,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “New treatment options such as empagliflozin can save lives and help people spend less time in the hospital and mor
SK Capital Reaches Agreement to Sell Niacet for $1,015m21.6.2021 10:00:00 CEST | Press release
An affiliate of funds advised by SK Capital Partners, LP (“SK Capital”) announced today that it reached agreement to sell Niacet Corp. (“Niacet”) to Kerry Group plc, the global taste and nutrition company, for $1,015m (€853m¹) on a cash-free, debt-free basis, subject to customary closing adjustments. Following the acquisition, Niacet will be integrated into Kerry’s global food protection and preservation platform. Jack Norris, Managing Director at SK Capital, said, “SK Capital is privileged to have partnered with Kelly Brannen and the entire Niacet team. We are proud and appreciative of Niacet’s accomplishments over the last four years leveraging the strong foundation the Brannen family built over many decades. We believe Niacet is well-positioned to continue this growth and flourish under Kerry’s ownership. We wish Kerry and all the employees of Niacet every success.” Kelly Brannen, CEO and significant minority owner of Niacet, commented, “We are proud of the rich heritage we have bui
ISAE-SUPAERO's "Collaborative Rover and Drone" Project, Facilitating the Exploration of the Moon21.6.2021 09:54:00 CEST | Press release
While Thomas Pesquet launched on April 22 as part of the Alpha mission, one of humanity's biggest challenges remains even further away than the ISS, 400,000 km from Earth: the establishment of a lunar base. But before being able to settle on the Moon in a prolonged way to exploit its resources or as a logistic support for future exploration missions further away, an exploration work is necessary. The use of autonomous robotic systems would allow mapping of dangerous or hard-to-reach areas from space, before eventually deploying infrastructure such as a spaceport or human habitation. Faced with this exploration challenge, the Space Advanced Concepts Laboratory (SaCLaB) of ISAE-SUPAERO in Toulouse and a team of students from the Institute are developing the Collaborative Rover and Drone (CoRoDro) project to study navigation and autonomous operations for space robotic systems. This scientific study is one of 12 university technology projects selected in 8 different countries as part of th
FXVIEW Goes Global, Sets up a Subsidiary in Saint Vincent and Grenadines21.6.2021 09:47:00 CEST | Press release
Fxview, Cyprus based forex and CFDs financial services company, announced today that it has set up an offshore subsidiary in St Vincent & The Grenadines. Until now, Fxview has been operating with its EU licenses from Cyprus. Charlgate SVG LLC, their locally incorporated arm will ensure the expansion of products and services on Fxview’s platforms. It will also allow them to offer regulated forex and CFDs trading services to traders around the globe. Fxview operates in Europe with its multiple European Licenses and is already an established brand in the EU market. Earlier this month, the company was acquired by a global FinTech leader Finvasia Group. “We anticipate that many more traders will join our platform where we plan to offer additional products and services like research & analysis, higher leverage, sophisticated trading tools, social trading, MAM / PAMM services, affiliate programs, loyalty reward programs and more,” said Rahul Bansal, Director of Charlgate SVG LLC. “We have bee
Ajay Kavan Joins KKR as a Senior Advisor in Europe21.6.2021 09:00:00 CEST | Press release
KKR, a leading global investment firm, today announces the appointment of Ajay Kavan as a Senior Advisor in Europe, effective immediately. Based in London, Mr. Kavan will support KKR’s pan-European investment activities in technology and digitally-enabled businesses and will advise KKR’s portfolio companies. In particular, he will focus on the consumer internet sector in eCommerce and direct-to-consumer offers, as well as companies undergoing major digital transformation programmes. Ajay most recently served as CEO of Matches Fashion, where he supported the business through the impact of the pandemic, strengthened the leadership team and improved customer experience, technology and operational performance. Prior to joining Matches he spent nine years in senior roles at Amazon including VP International Special Projects, VP Amazon Fresh International and VP UK Consumables. He was responsible for launching Amazon Fresh across Europe and Asia, developing strategic partnerships with retail
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