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Oxford Immunotec’s T-SPOT® Discovery SARS-CoV-2 Test is Used to Measure the Efficacy of Valneva’s VLA2001 COVID-19 Vaccine Candidate in a Phase I/II Clinical Study

Oxford Immunotec Global PLC
·8-min read

OXFORD, United Kingdom and MARLBOROUGH, Mass., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company, announce the start of a collaboration with Valneva. The Company will perform T cell testing on participants receiving Valneva’s inactivated whole-virus COVID-19 vaccine candidate (VLA2001) with the research use only T-SPOT Discovery SARS-CoV-2 test. The VLA2001-201 study is a randomized Phase I/II clinical study designed to evaluate the safety, tolerability and immunogenicity of an inactivated SARS-CoV-2 virus vaccine candidate in healthy subjects, the first study of its kind performed in Europe.

The Company’s T-SPOT Discovery SARS-CoV-2 test will assess if the vaccination induces a T cell response in study subjects.

T-SPOT Discovery SARS-CoV-2 builds on the Company’s experience with their T-SPOT technology platform, used clinically for diagnosis of TB (the T-SPOT.TB test) and the assessment of the immune response to CMV in transplant patients (the T-SPOT.CMV test). The T-SPOT technology platform is a commercialized and regulated ELISPOT platform, which allows for the standardized and reproducible measurement of T cells reactive to SARS-CoV-2. It also allows centralization of sample processing when used with the Company’s T-Cell Xtend® reagent, which extends the time from sample collection to the start of sample processing to up to 32 hours.

The T-SPOT Discovery SARS-CoV-2 test has demonstrated in previous studies that SARS-CoV-2 responsive T cell numbers were associated with protection from COVID-191. Collecting T cell data in the VLA2001-201 study may add valuable additional information for assessing the efficacy of Valneva’s inactivated whole-virus vaccine candidate.

Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said, “I am proud of all the hard work being done by our teams to enable our T cell test to be used to better understand the efficacy of this vaccine candidate. Understanding the T cell response as well as the antibody response will lead to a greater understanding of the breadth of the immune response to this candidate, and that could be vitally important, particularly as new variants of SARS-CoV-2 continue to appear.”

For additional information, please visit: https://tspotdiscovery.com and https://valneva.com/press-release/valneva-initiates-phase-1-2-clinical-study-of-inactivated-adjuvanted-covid-19-vaccine-candidate/

1 Wyllie D, Mulchandani R, Jones H et al. “SARS-CoV-2 responsive T cell numbers are associated with protection from COVID-19: A prospective cohort study in keyworkers”. MedRxIV Nov 4 2020. https://www.medrxiv.org/content/10.1101/2020.11.02.20222778v1 (Preprint)

T-SPOT Discovery SARS-CoV-2 is for research use only, not for use in diagnostic procedures.

T-SPOT, the Oxford Immunotec logo, and T-Cell Xtend are trademarks of Oxford Immunotec Limited.

About Oxford Immunotec

Oxford Immunotec Global PLC is a global, high-growth diagnostics company. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT®.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. The Company is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The Company has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States (where it has received pre-market approval from the Food and Drug Administration), Europe (where it has obtained a CE mark), as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.

About Valneva SE

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s commercial portfolio includes two vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees. For more information, visit the Company website at www.valneva.com and follow Valneva on LinkedIn.

About T-SPOT Discovery SARS-CoV-2

Oxford Immunotec has been developing and strengthening its expertise in T cell measurement for over 15 years since the introduction of its T-SPOT technology in the field of TB diagnostics. In that time, we have taken the classic ELISPOT technique and developed it into the world leading proprietary T-SPOT technology platform we now use to measure T cell immune responses, improving performance, standardizing results, and streamlining the workflow. This high performance is ensured by our regularly audited manufacturing facility operating to our rigorous quality management system. The T-SPOT.TB test, an in vitro diagnostic (IVD) test using the T-SPOT technology platform, has been granted regulatory approval for clinical diagnostic use in over 50 countries, including US, EU, Japan and China. The research use-only T-SPOT Discovery SARS-CoV-2 assay uses this same T-SPOT technology to allow SARS-CoV-2-specific T cells to be detected and enumerated. The optimized antigen mix used in the test is based on SARS-CoV-2 structural proteins and allows the maximum breadth of the immune response to be measured. The Company’s single antigen-per-well approach allows specific information about the immune response to different SARS-CoV-2 antigens to be gathered in parallel. Sample processing can be centralised whilst still enabling testing on fresh (rather than frozen) blood, using the Company’s T-Cell Xtend reagent (32 hr room temperature (RT) sample stability).

About VLA2001-201

VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited. The study includes an open-label dose-escalation phase and will be conducted as a randomized, double-blind, multicenter study. On January 8th 2021, a Data Safety Monitoring Board (DSMB) gave approval to progress into the study’s full randomization phase. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated.

Forward-Looking Statements

Certain statements in this press release constitute forward-looking statements within the meaning of applicable U.S. and U.K. laws and regulations, including under the U.S. Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “plans,” “intends,” “projects,” and “future” or similar expressions that are intended to identify forward-looking statements. Any statements contained herein which do not describe historical or current facts, including plans for and the expected impact of the collaboration with Valneva, expectations for the interaction of SARS-CoV-2 responsive T cell numbers and protection from COVID-19 and the role and importance of T cell data in the VLA2001-201 study in assessing the efficacy of the new vaccine candidate, constitute forward-looking statements. Any forward-looking statements are based on our management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the possibility that measuring T cells in any aspect of vaccine research may not be as important as expected, the T cell response might not play as important of a role as expected in combatting the virus, the T cell testing may not help in understanding of the efficacy of new vaccines, the ability to execute on the collaboration with Valneva and the parties' ability to deliver on the expected benefits of the collaboration, disruptions in the global economic and political environments, the risks associated with Oxford Immunotec’s recently announced pending sale to PerkinElmer, Inc. as well as those other risks and uncertainties described in Oxford Immunotec’s filings with the U.S. Securities and Exchange Commission (the “Commission”), including Oxford Immunotec’s Annual Report on Form 10-K for the year-ended December 31, 2019 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020, and in any other reports it files with the Commission, including Current Reports on Form 8-K. Oxford Immunotec’s SEC filings are available for free by visiting the investor section of its website, www.oxfordimmunotec.com, or the SEC’s website, www.sec.gov.

Investors should give careful consideration to these risks and uncertainties. Forward-looking statements contained herein are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance. Investors should not place undue reliance on forward-looking statements contained herein, which speak only as of the date of this release. Oxford Immunotec does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law.

For Investor Inquiries:
Matt McLaughlin
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
mtmclaughlin@oxfordimmunotec.com