Novavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May

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NVX-CoV2373 identified as SARS-CoV-2 candidate for Phase 1 clinical trial
In preclinical studies, NVX-CoV2373 demonstrated high immunogenicity and stimulated high levels of neutralizing antibodies First-in-human Phase 1 clinical trial accelerated to mid-May with preliminary results in July
GMP clinical production initiated at Emergent BioSolutions with ability to leverage capacity for large scale manufacturing

GAITHERSBURG, Md., April 08, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology com next-generation vaccines for serious infectious diseases, today announced it has identified a coronavirus vaccine candidate, stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and will initiate a first-in-human trial in mi proprietary Matrix-MTM adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulat neutralizing antibodies.

NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodie binding of the spike protein to the receptor and wild-type virus neutralizing antibodies. High levels of spike protein-specific antib 2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were observe immunization. In addition, the already high microneutralization titers seen after one dose increased eight fold with a second microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.

“Our scientists identified an ideal vaccine candidate selected from a number of constructs and, in partnership with Dr. M demonstrated that NVX-CoV2373 produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies,” said M.D., President of Research and Development at Novavax. “In addition, we have worked closely with our colleagues at Emergent transfer our production technology that allows the manufacture of GMP vaccine for clinical trials. With preliminary CEPI fundi efforts, combined with the candidate’s excellent early results, put us in position to have preliminary human data in July.”

“We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus,” said Matthew Associate Professor at the University of Maryland School of Medicine. “This is strong evidence that the vaccine created by potential to be highly immunogenic in humans which could lead to protection from COVID-19 and helping to control the spread of

The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the cur pandemic. The Phase 1 clinical trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assess amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety result

As previously announced, in March, Novavax entered into an agreement with Emergent BioSolutions to provide contract d manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials. This agreement offers the pote Emergent’s rapid deployment capabilities and expertise that provide Novavax scalability and capacity to produce vaccine produc the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support Novavax’ efforts funding discussions ongoing.

“Because of the tireless efforts and commitment of the Novavax team and our collaborators, we are preparing to initiate th Phase 1 trial in mid-May, weeks ahead of schedule,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.

   

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demonstrates the ability of our recombinant nanoparticle technology to rapidly create vaccine candidates for emerging viruses li In addition, the performance of NVX-CoV2373 in multiple preclinical studies and testing gives us increased confidence in its pot against COVID-19 disease.”

About Coronavirus

A new strain of coronavirus, SARS-CoV-2, first appeared in late 2019 in China before beginning its rapid spread across the glo

named COVID-19, continues to cause severe pneumonia-like symptoms in many of those infected. Coronaviruses, so named for t

appearance, are a large family of viruses that spread from animals to humans and include diseases such as Middle East Respir

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(MERS) and SARS in addition to COVID-19. While much remains unknown about the new coronavirus, it is known that the viru human-to-human transmission before any symptoms appear.

About Matrix-MTM

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the e presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, glob Novavax recently initiated development of a vaccine program against COVID-19, with human results expected in July of 202 quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial. ResVaxTM, its RSV va via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax is a leading innovator vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently class of highly immunogenic nanoparticles addressing urgent global health needs.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which co results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those ide heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with th Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contai release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks an The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligati revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced a potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors Novavax, Inc. Erika Trahan ir@novavax.com 240-268-2022

Westwicke
John Woolford john.woolford@westwicke.com 443-213-0506

Media
Brandzone/KOGS Communication Edna Kaplan
kaplan@kogspr.com 617-974-8659

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Source: Novavax, Inc.

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