Malaria Vaccine Phase 2b Clinical Trial Results Published in Lancet Preprint | Status

Gaithersburg, Maryland, April 23, 2021 / PRNewswire /-Novavax, Inc., a biotechnology company developing next-generation vaccines for serious infectious diseases. (Nasdaq: NVAX) today announced the release of a preprint of data from the phase. 2b A clinical trial of children demonstrating the efficacy of 77% of R21, a malaria vaccine candidate created by Oxford College Contains Novavax’s Matrix-M ™ adjuvant and is licensed to the Serum Institute of. India (SII).Published online Lancet preprintThe high level of preventive effect of this vaccine has the potential to be an important tool for the eradication of malaria worldwide.

Phase 2b A randomized controlled double-blind study was conducted at Nanoro’s Clinical Research Unit (CRUN) / Institut de Recherche en Sciencesdela Santé (IRSS). Burkina Faso, And recruited 450 participants from the highly seasonal malaria-infected Nanoro catchment area.

In the three study groups, participants aged 5 to 17 months were vaccinated with 5 mg of R21, including 25 mg or 50 mg of Matrix-M, or a rabies vaccine as a control. The researchers reported vaccine efficacy of 77% in the high adjuvant dose group and 71% in the low adjuvant dose group. The publication reports that both adjuvant dose levels were well tolerated in infants who had not reported a serious response to the vaccine. In addition, participants vaccinated with R21 / Matrix-M showed high titers of malaria-specific anti-N-acetylneuraminate phosphatase (NANP) antibody 28 days after the third vaccination, which is more High adjuvant dose almost doubled. After the fourth dose, given one year later, antibody levels were boosted to levels similar to the peak titers achieved after the primary series of vaccinations.

The Matrix-M component of the malaria vaccine is manufactured by Novavax and supplied to SII. Under the Novabax agreement with the Serum Institute, SII reserves the right to use Matrix-M in vaccines in areas where the disease is endemic and will pay Novabax royalties for market sales of the vaccine. In addition, Novavax has the commercial right to sell and distribute vaccines manufactured in SII in certain countries, primarily in the tourist and military vaccine markets.

“These important results support our high expectations for the potential of this vaccine, including the achievement of the WHO-stated goals for a malaria vaccine with at least 75% efficacy,” he said. .. Adrian Hill, Lakshmi Mittal and a family professor of vaccine science.Director of Jenner Institute Oxford CollegeCo-director of the Oxford Martin Program on Vaccines and co-author of publications. “Our commercial partner, the Serum Institute of IndiaWe believe that this vaccine has the potential to have a significant impact on public health, as it will produce at least 200 million doses annually in the next few years. “

In 2019, an estimated 229 million malaria cases occurred worldwide, killing an estimated 409,000 people. Children under the age of 5 are the most vulnerable, accounting for 67% of the world’s deaths in 2019. Phase 3 vaccine trials have begun recruitment at five trial centers in four countries with different malaria transmission rates and seasonality. Africa Study large-scale safety and efficacy.

“The Novavax team is pleased to be part of the collaboration that has led to today’s significant advances in global health issues over the years.” Gregory M. Glen, MD, President, R & D, Novavax. “Novavax’s Matrix-M adjuvant, used with the Oxford R21 antigen, is highly capable of minimizing the dose required, thereby increasing the number of doses available and protecting the world’s most vulnerable population, children. It stimulates an effective immune response. “

“We are excited to work together Oxford College Novabax on the successful development of the malaria vaccine. ” Cyrus Poonawalla, Chairman and Managing Director of Serum Institute of Serum Institute India.. “Once licensed, we promise to supply 200 million doses of vaccine each year at a very cost-effective price.”

The results are detailed in “Efficacy of Low-Dose Candidate Malaria Vaccines, R21 in the adjuvant Matrix-M”.^TMWith seasonal management to children Burkina Faso: Randomized controlled trials “is available online Here..

About R21

R21 is produced by expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, which contains a central repeat of perisporozoite protein (CSP) fused to the N-terminus of HBsAg10 and the C-terminus, and is produced by the Serum Institute of India Private Ltd. I did. (SIIPL). R21 was mixed with Matrix-M ™, a saponin-based vaccine adjuvant manufactured by Novavax AB of Uppsala, just prior to administration. Sweden..

Development of Targeted Vaccine R21 / Matrix-M Plasmodium falciparum Malaria was accelerated in collaboration with the Jenner Institute. Oxford College, Serum Institute of India Pvt Ltd. and Novavax, Inc. Works with many clinical trial units in the UK Africa..

About Matrix-M ™

Novavax’s patented saponin-based Matrix-M ™ adjuvant is powerful and shinobi by stimulating the entry of antigen-presenting cells into the injection site, enhancing antigen presentation in local lymph nodes and boosting the immune response. It showed a highly tolerant effect.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes health improvement globally through the discovery, development and commercialization of innovative vaccines that prevent serious infectious diseases. The company’s unique recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. Novavax is conducting end-stage clinical trials of NVX-CoV2373, a vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, a tetravalent influenza nanoparticle vaccine, has achieved all major objectives in critically important Phase 3 clinical trials in the elderly and is being submitted to regulatory authorities. Both vaccine candidates incorporate Novavax’s unique saponin-based Matrix-M ™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, please visit: www.novavax.com Connect with us twitter And LinkedIn..

A description of Novavax’s future outlook

The statements in this document regarding the future of Novavax and the continued development of its vaccine and adjuvant products are forward-looking statements. Novavax warns that these forward-looking statements carry a number of risks and uncertainties and that actual results may differ materially from those expressed or implied by such statements. I will. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended. December 31, 2020, As submitted to the Securities and Exchange Commission (SEC). We warn investors not to rely heavily on the forward-looking statements contained in this press release. We recommend that you read the documents submitted to the SEC. sec.gov, For discussion of these and other risks and uncertainties. Forward-looking statements in this press release are made only as of the date of this document and we undertake no obligation to update or revise these statements. Our business is exposed to significant risks and uncertainties, including those listed above. Investors, potential investors, and others should carefully consider these risks and uncertainties.

contact information:

Investor

Novavax, Inc.

Erica Schultz 240-268-2022

[email protected]

Soleberry trout

Jennifer Porcelli | 646-378-2962

[email protected]

Novavax Media

Amy Speak | 617-420-2461

Laura Keenan | 410-419-5755

[email protected]

To download multimedia, view the original content.http://www.prnewswire.com/news-releases/malaria-vaccine-phase-2b-clinical-trial-results-published-in-preprints-with-the-lancet-301275699.html

Source Novavax, Inc.