REG - GlaxoSmithKline PLC - Medicago/GSK COVID-19 vaccine positive Ph3 data

GSKAnnouncement

07/12/2021 12:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20211207:nRSG8512Ua&default-theme=true

RNS Number : 8512U  GlaxoSmithKline PLC  07 December 2021

Issued: 7 December 2021, London UK and Quebec City, Canada

 

Medicago and GSK announce positive Phase 3 efficacy and safety results for
adjuvanted plant-based COVID-19 vaccine candidate

·   Primary endpoints and secondary endpoints for which data are available
were met in trial dominated by COVID-19 variants

·   Efficacy demonstrated against all variants seen in the study, including
75.3% efficacy against COVID-19 of any severity caused by the globally
dominant Delta variant

·   Vaccine candidate was well-tolerated, with no related serious adverse
events reported in the vaccine group

·   Final regulatory submission to be filed with Health Canada imminently

 

 

Medicago, a biopharmaceutical company headquartered in Quebec City, and
GlaxoSmithKline plc (GSK) today announce positive efficacy and safety results
from the global Phase 3 placebo-controlled efficacy study of Medicago's
plant-based COVID-19 vaccine candidate in combination with GSK's pandemic
adjuvant, conducted in over 24,000 subjects (adults 18 years and above) across
six countries.

 

Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2
variants, unlike most published Phase 3 efficacy trials for currently licensed
COVID-19 vaccines that were conducted when only the ancestral virus was
circulating, making direct comparisons impossible. The overall vaccine
efficacy rate against all variants of SARS-COV-2 was 71% (95% CI: 58.7, 80.0;
Per Protocol Analysis: PP). The corresponding number for people with an
initial seronegative status indicating no previous exposure to COVID-19 was
75.6% (95% CI: 64.2-83.7; PP). The vaccine candidate demonstrated efficacy of
75.3% (95% CI: 52.8, 87.9; PP) against COVID-19 of any severity for the
globally dominant Delta variant. Efficacy was 88.6% (95% CI: 74.6, 95.6; PP)
against the Gamma variant. Although only a small number of severe cases
occurred in this study, none occurred in the vaccinated group. No cases of the
Alpha, Lambda and Mu variants were observed in the vaccinated group while 12
cases were observed in the placebo group. The Omicron variant was not
circulating during the study.

 

During the study, no related serious adverse events were reported and
reactogenicity was generally mild to moderate and transient; symptoms lasting
on average only one to three days. To date, the Phase 3 results have confirmed
the safety profile is consistent with Phase 2 results. The frequency of mild
fever was low (<10%), even after the second dose. Full results of the Phase
3 study will be released in a peer-reviewed publication as soon as possible.

 

Based on these results, Medicago will imminently seek regulatory approval from
Health Canada as part of its rolling submission. The vaccine candidate is not
yet approved by any regulatory authority.

 

"This is an incredible moment for Medicago and for novel vaccine platforms.
The results of our clinical trials show the power of plant-based vaccine
manufacturing technology. If approved, we will be contributing to the world's
fight against the COVID-19 pandemic with the world's first plant-based vaccine
for use in humans," said Takashi Nagao, CEO and President at Medicago. "I want
to thank everyone who participated in our clinical trials, our collaborators
at clinical trial sites, our partners at GSK, the Government of Canada and
Government of Quebec, all of our employees and Mitsubishi Tanabe Pharma
Corporation, for their commitment to advancing vaccine science when the world
needs it."

 

Thomas Breuer, GSK's global COVID-19 adjuvanted vaccines lead and Chief Global
Health Officer, said, "These are encouraging results given data were obtained
in an environment with no ancestral virus circulating. The global COVID-19
pandemic is continuing to show new facets with the current dominance of the
Delta variant, upcoming Omicron, and other variants likely to follow. The
combination of GSK's established pandemic adjuvant with Medicago's plant-based
vaccine technology has significant potential to be an effective,
refrigerator-stable option to help protect people against SARS-CoV-2."

 

Medicago has been developing its plant-based technology for the past 20 years,
using unique technology to produce Virus-Like Particles (VLP) for its protein
vaccines. VLPs are designed to mimic the native structure of viruses, allowing
them to be easily recognised by the immune system. Because the VLPs lack core
genetic material, they are non-infectious and unable to replicate. VLP
vaccines developed by other technologies have traditionally been used
worldwide for more than 30 years.

 

"I am pleased to see our vaccine candidate moving forward and bringing to the
world the first plant-based vaccine against COVID-19, diversifying the pool of
vaccines available to help improve public health and protect more people,"
said Yosuke Kimura, Chief Scientific Officer at Medicago.

 

Medicago has initiated the regulatory filing process for the adjuvanted
plant-based COVID-19 vaccine candidate with the FDA (US) and the MHRA (UK).
Preliminary discussion is underway with the WHO for preparation of the
submission. Medicago has also initiated a Phase 1/2 trial in Japan where it
plans to submit for regulatory approval in combination with the Phase 2/3
global study results next spring.

About the Phase 2/3 study

The Phase 2/3 study has a multi-portion design to confirm that the chosen
formulation and dosing regimen of the vaccine candidate (two doses of 3.75 µg
of antigen combined with GSK's pandemic adjuvant given 21 days apart) has an
acceptable vaccine 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-based vaccine candidate in subjects aged
18 and above. It was conducted in multiples sites in Canada and the United
States in 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 vaccine candidate: placebo
and with 2:1 stratification in older adults (65-74 and ≥75). All subjects
are being followed for a period of 12 months after the last vaccination for
assessment of safety and the durability of the immune responses which will be
the final analysis.

 

The Phase 3 portion of the trial was launched in March 2021 and was an
event-driven, randomized, observer-blinded, crossover placebo-controlled
design that evaluated the efficacy and safety of the vaccine candidate
formulation, compared to placebo, in over 24,000 subjects across Canada, the
United States, United Kingdom, Mexico, Argentina, and Brazil.

 

The data communicated are Per-Protocol, meaning only data from participants
who followed the protocol throughout the study are included. A parallel
Intention to Treat (ITT) analysis that considers the treatment received by all
participants, without regard to protocol adherence yielded very similar
results.

The vaccination regimen calls for two doses (3.75 microgram of antigen in
combination with GSK's pandemic adjuvant) given intramuscularly 21 days apart.
The vaccine is stored at 2 °C to 8 °C, enabling the use of traditional
vaccine supply and cold chain channels.

 

 

 

GSK commitment to tackling COVID-19

GSK's response to COVID-19 has been one of the broadest in the industry, with
potential treatments in addition to our vaccine candidates in development with
partner organisations.

GSK is collaborating with several organisations on COVID-19 vaccines by
providing access to our adjuvant technology. We are working with Sanofi,
Medicago and SK bioscience to develop adjuvanted, protein-based vaccines,
and all are now in Phase III clinical trials. The use of an adjuvant can
be of particular importance in a pandemic since it may reduce the amount of
vaccine protein required per dose, allowing more vaccine doses to be produced
and contributing to protect more people in need.

GSK is also working with mRNA specialist, CureVac, to jointly develop next
generation, optimised mRNA vaccines for COVID-19 with the potential to address
multiple emerging variants in one vaccine.

GSK is also exploring treatments for COVID-19 patients, collaborating with Vir
Biotechnology to investigate monoclonal antibodies that could be used as
therapeutic or preventive options for COVID-19.

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 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 (http://www.medicago.com)

 

About GSK

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 (https://www.gsk.com/en-gb/about-us/) .

 

 GSK enquiries:
 Media enquiries:             Tim Foley         +44 (0) 20 8047 5502  (London)
                              Simon Moore       +44 (0) 20 8047 5502  (London)
                              Kristen Neese     +1 804 217 8147       (Philadelphia)
                              Kathleen Quinn    +1 202 603 5003       (Washington DC)

 Analyst/Investor enquiries:  Nick Stone        +44 (0) 7717 618834   (London)
                              Sonya Ghobrial    +44 (0) 7392 784784   (Consumer)
                              James Dodwell     +44 (0) 20 8047 2406  (London)
                              Mick Readey       +44 (0) 7990 339653   (London)
                              Jeff McLaughlin   +1 215 751 7002       (Philadelphia)
                              Frannie DeFranco  +1 215 751 4855       (Philadelphia)

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the Company's Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUPGPCPUPGGGM