NanoFlu Demonstrated Improved Immune Response in Clinical Trial

The New England Journal of Medicine (NEJM) published a peer-reviewed letter to the editor detailing the positive results from an early-stage flu vaccine clinical trial.

This small, phase 1/2 clinical trial in older adults compared Matrix- M™ adjuvanted nanoparticle seasonal influenza vaccine candidate (NanoFlu), to the leading licensed egg-based, high-dose influenza vaccine (IIV3-HD).

The NEJM letter said ‘NanoFlu demonstrates significantly improved immune responses against a panel of homologous and drifted A(H3N2) influenza viruses compared to leading licensed egg-based, high-dose flu vaccine in older adults.’

“These results showcase the potential benefit NanoFlu could have for older adults, a population challenged by poor immune responses,” said Dr. Vivek Shinde, Executive Director, Clinical Development at Novavax, and lead author of the letter.

“This population faces an urgent unmet medical need for a more effective flu vaccine, as highlighted by the severe flu season of 2017-2018,” said Dr. Shinde in a press release.

In February 2018, Novavax reported the positive top-line results from the NanoFlu Phase 1/2 clinical trial in older adults. Details of the data, as published in this letter, include that NanoFlu in comparison to IIV3-HD induced:

• Hemagglutination inhibition (HAI) immune responses that were 28 to 64% greater against the homologous and four generations of drifted wild-type A(H3N2) influenza strains; and
• Higher HAI responses against the homologous A(H1N1) strain and comparable responses against the homologous B/Brisbane strain.

“We are pleased to be able to share the detailed data from the NanoFlu Phase 1/2 clinical trial with the broader scientific community,” said Stanley C. Erck, President and Chief Executive Officer of Novavax, Inc.

“The low effectiveness of seasonal influenza vaccines, and in particular the A(H3N2) component of the vaccine, during the 2017-2018 season emphasizes the need for a more effective vaccine.”

“Our non-egg-based, recombinant nanoparticle vaccine, when coupled with Matrix-M, potentially offers broader protection against rapidly evolving drift strain variants.”

“We look forward to advancing this vaccine into the planned Phase 2 clinical trial of quadrivalent NanoFlu in the third quarter of 2018,” said Erck.

About the Phase 1/2 Clinical Trial:

Novavax, Inc. conducted a randomized, observer-blind, comparator-controlled trial of NanoFlu (in two trivalent formulations: 45µg or 180µg total HA) against IIV3-HD in 330 healthy adults aged 60 years or older.

Immunogenicity was measured by HAI and neutralization antibody responses against a panel of vaccine-homologous, and historically forward-drifted, influenza virus strains.

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax in its SF9 insect cell-baculovirus system. NanoFlu uses HA amino acid protein sequences that are substantially the same as wild-type circulating virus HA sequences.

NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated 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.

Novavax, Inc. is a clinical-stage biotechnology company. For more information, please visit www.novavax.com.