The Coalition for Epidemic Preparedness Innovations (CEPI) will provide Novavax with up to $384 million in additional funding toward clinical development and large-scale manufacturing of the company’s COVID-19 vaccine candidate NVX-CoV2373, CEPI and the company said.

The funding multiplies CEPI’s investment in NVX-CoV2373, which began with a $4 million award in March. Novavax’s total $388 million in CEPI funding accounts for 87% of the total $446 million awarded by the Coalition toward COVID-19 vaccine R&D.

NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology, and incorporating its saponin-based Matrix-M™ adjuvant, designed to enhance immune responses. The company disclosed it was assessing multiple nanoparticle vaccine candidates in animal models in February, and identified its vaccine candidate in April.

NVX-CoV2373 is among 70 candidates GEN was “Keeping an Eye On…” among 160+ COVID-19 therapeutics under study in GEN’s updated A-List published April 13, “Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development.”

“For the last few months, the entire Novavax team has been working nonstop in an ongoing effort to make our vaccine a reality, and we appreciate CEPI’s confidence in our technology platform and our progress,” Novavax president and CEO Stanley C. Erck said in a statement. “CEPI plays a vital role in advancing innovative technologies against the COVID-19 pandemic. Their partnership and support allows Novavax to leverage its innovative vaccine platform and expertise in this global crisis.”

CEPI said it will fund preclinical as well as Phase I and Phase II studies of NVX-CoV2373. Novavax has disclosed on plans for 2019nCoV-101 (NCT04368988), a two-part randomized, observer-blinded, placebo-controlled Phase I/II trial designed to evaluate the immunogenicity and safety of the vaccine with or without Matrix-M adjuvant in healthy participants ≥ 18 to 59 years of age.

Up to two vaccine constructs

In the Phase I portion, at least one and up to two vaccine constructs will be evaluated in up to two cohorts, which may be enrolled in parallel. Topline results are expected in July. Based on an interim analysis of Phase I safety and immunogenicity data, the trial will be expanded to Phase II.

The Phase I portion is set to start this month in Australia, followed by Phase II clinical trials to be conducted in multiple countries. If the Phase I/II trial is successful, CEPI said, it anticipates supporting further clinical development that would advance NVX-CoV2373 through to licensure.

Novavax has cited preclinical studies showing that NVX-CoV2373 induced robust neutralizing antibody responses.

CEPI’s funding is also intended to support the transfer of NVX-CoV2373 technology to manufacturing partners worldwide, as well as enable large-scale production of Novavax’s saponin-based Matrix-M adjuvant in Novavax’s manufacturing facility in Uppsala, Sweden, and a second production site to be determined.

According to Novavax, Matrix-M has shown a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response and helping an immunized person make antibodies against the virus.

Up to one billion doses

In addition, CEPI and Novavax said, the funding will allow the company to begin the manufacture of a potential 100 million vaccine doses by year’s end, with the company ramping up to potentially over one billion doses during 2021.

CEPI and Novavax also agreed to allow procurement and allocation of NVX-CoV2373 through worldwide efforts now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO and global leaders last month.

Novavax is one of nine entities with which CEPI is partnering with on vaccine development.

“Our vaccine R&D programs are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale,” stated CEPI CEO Richard Hatchett, MD. “We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible.”

CEPI is a partnership of public, private, philanthropic, and civil organizations launched at Davos in 2017 to develop vaccines against future epidemics by advancing them into clinical development as soon as possible.

Before the COVID-19 pandemic arose, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome (MERS) coronavirus, Nipah virus, Rift Valley fever, and Chikungunya virus. CEPI has also funded platform technologies designed for rapid vaccine and immunoprophylactic development against unknown pathogens.

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