PR98682

 

GAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire=KYODO JBN/ --

 

-- The Novavax BA.1 vaccine candidate met its primary strain-change endpoint

allowing for development of variant vaccines, if necessary

-- Novavax' prototype vaccine induced broad immune response against original

Wuhan, BA.1, and BA.5 strains

-- The trial showed no benefit for a bivalent vaccine utilizing Novavax'

recombinant protein/adjuvant technology

 

 

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing

and commercializing next-generation vaccines for serious infectious diseases,

today announced topline results from its Phase 3 Boosting Trial for the

SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1

vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The

data demonstrate that the BA.1 vaccine candidate neutralizing responses in

those not previously exposed to COVID-19 were greater than those of the

prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if

necessary (see chart 1).

 

Additionally, data show no benefit for the Novavax bivalent vaccine candidate

compared to the BA.1 vaccine candidate or prototype vaccine in the overall

trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and

prototype strains showed similar responses across the three vaccine groups

(prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype +

BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 strain (which is

structurally similar to BA.1), pseudoneutralization responses demonstrated that

there was no benefit for the BA.1 or bivalent vaccine candidates compared to

the prototype vaccine.**

 

Overall, the data demonstrated that the prototype vaccine induced a broad

immune response against original prototype, BA.1, and BA.5 strains. The

prototype vaccine induced robust IgG responses to both BA.1 and the matched

prototype strain.* Pseudoneutralization responses against BA.5 for the

prototype vaccine were comparable to those induced by the more closely matched

BA.1 vaccine and bivalent vaccine candidates.*

 

"Today's results show that use of our prototype vaccine as a booster induces

cross-reactive responses to a broad range of variants with the potential to

protect against future strains. This is a hallmark of our vaccine technology

and shows the suitability of our current prototype vaccine as a booster even as

the COVID-19 landscape continues to evolve," said Gregory M. Glenn, M.D.,

President of Research and Development, Novavax. "Our vaccine, which provides

broad immune response even in the face of evolving variants, presents a

potential strategy to protect against COVID-19 now and into the future."

 

When given as a second booster dose (fourth dose), all three vaccine

formulations were similarly well-tolerated, consistent with the

well-established safety profile of the prototype vaccine. The most common local

solicited symptom was pain/tenderness (BA.1 69%, prototype 71%, bivalent 65%).

The most common systemic solicited symptoms were fatigue and malaise (BA.1 45%,

prototype 41%, bivalent 45%), headache (BA.1 38%, prototype 35%, bivalent 36%),

muscle pain (BA.1 25%, prototype 24%, bivalent 24%), and joint pain (BA.1 10%,

prototype 11%, bivalent 6%), with the majority of reactions being mild or

moderate.

 

Chart 1: Geometric Mean Ratio of BA.1 wild-type Neutralizing Responses (Day 14)

Study Arm in Participants Not Previously Infected

 

 

	Group Comparisons
Neutralizing antibodies for BA.1	BA.1 vaccine to prototype vaccine	Bivalent vaccine to prototype vaccine	Bivalent vaccine to BA.1 vaccine
Geometric Mean Ratio (GMR)	1.6	1.2	0.7
GMR 95% Confidence Interval	1.31, 2.03	0.94, 1.44	0.57, 0.89

*IgG responses are not statistically significant.

**Fit-for-purpose analysis being confirmed with validated assay.

 

About the Phase 3 Omicron Trial

Novavax' Phase 3 Omicron trial is a two-part, observer blinded, randomized

trial to evaluate Omicron subvariant vaccine candidates. NVX-CoV2515 (BA.1) and

bivalent (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates were

compared to NVX-CoV2373 in adults aged 18 to 64 previously vaccinated with

three doses of mRNA vaccines. All formulations include the Matrix-M(TM)

adjuvant to enhance and broaden the immune response. The trial is evaluating

the reactogenicity and immune responses to all three formulations. The trial's

primary endpoints include measures of immune response, and its secondary

endpoints include additional measurements of immune responses and safety

measures. The trial plans to enroll 2,090 adults aged 18 to 64 across 19 sites

in Australia.

 

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of

the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The

vaccine was created using Novavax' recombinant nanoparticle technology to

generate antigen derived from the coronavirus spike protein and is formulated

with Novavax' patented saponin-based Matrix-M(TM) adjuvant to enhance the

immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and can neither replicate, nor

can it cause COVID-19.

 

The vaccine is packaged as a ready-to-use liquid formulation in a vial

containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg

antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The

vaccine is stored at 2”degrees”- 8”degrees” Celsius, enabling the use of

existing vaccine supply and cold chain channels. Use of the vaccine should be

in accordance with official recommendations.  

 

Novavax has established partnerships for the manufacture, commercialization,

and distribution of the vaccine worldwide. Existing authorizations leverage

Novavax' manufacturing partnership with Serum Institute of India, the world's

largest vaccine manufacturer by volume. They will later be supplemented with

data from additional manufacturing sites throughout Novavax' global supply

chain.

 

About Matrix-M(TM) Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant 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,

boosting immune response.

 

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved

health globally through the discovery, development, and commercialization of

innovative vaccines to prevent serious infectious diseases. The company's

proprietary recombinant technology platform harnesses the power and speed of

genetic engineering to efficiently produce highly immunogenic nanoparticles

designed to address urgent global health needs. The Novavax COVID-19 vaccine

has received authorization from multiple regulatory authorities globally,

including the U.S. Food and Drug Administration, the European Commission, and

the World Health Organization. The vaccine is currently under review by

multiple regulatory agencies worldwide, including for additional populations

and indications such as adolescents and as a booster. In addition to its

COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza

Combination (CIC) vaccine candidate in a Phase 1/2 clinical trial, its

quadrivalent influenza investigational vaccine candidate, and an Omicron

strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based /

original strain-based vaccine. These vaccine candidates incorporate Novavax'

proprietary saponin-based Matrix-M adjuvant to enhance the immune response and

stimulate high levels of neutralizing antibodies.

 

For more information, visit www.novavax.com and connect with us on LinkedIn (

https://c212.net/c/link/?t=0&l=en&o=3460980-1&h=91088807&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3457869-1%26h%3D1725473980%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3440781-1%2526h%253D2733326919%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3395501-1%252526h%25253D853375093%252526u%25253Dhttps%2525253A%2525252F%2525252Fc212.net%2525252Fc%2525252Flink%2525252F%2525253Ft%2525253D0%25252526l%2525253Den%25252526o%2525253D3392093-1%25252526h%2525253D1325598136%25252526u%2525253Dhttps%252525253A%252525252F%252525252Fc212.net%252525252Fc%252525252Flink%252525252F%252525253Ft%252525253D0%2525252526l%252525253Den%2525252526o%252525253D3387216-1%2525252526h%252525253D2935962557%2525252526u%252525253Dhttps%25252525253A%25252525252F%25252525252Fc212.net%25252525252Fc%25252525252Flink%25252525252F%25252525253Ft%25252525253D0%252525252526l%25252525253Den%252525252526o%25252525253D3260461-1%252525252526h%25252525253D1508558197%252525252526u%25252525253Dhttps%2525252525253A%2525252525252F%2525252525252Fc212.net%2525252525252Fc%2525252525252Flink%2525252525252F%2525252525253Ft%2525252525253D0%25252525252526l%2525252525253Den%25252525252526o%2525252525253D3158017-1%25252525252526h%2525252525253D3702938248%25252525252526u%2525252525253Dhttps%252525252525253A%252525252525252F%252525252525252Fwww.linkedin.com%252525252525252Fcompany%252525252525252Fnovavax%252525252525252F%25252525252526a%2525252525253DLinkedIn%252525252526a%25252525253DLinkedIn%2525252526a%252525253DLinkedIn%25252526a%2525253DLinkedIn%252526a%25253DLinkedIn%2526a%253DLinkedIn%26a%3DLinkedIn&a=LinkedIn

) .

 

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and

prospects,   the timing of clinical trial results, the ongoing development of

NVX-CoV2373, including NVX-CoV2515 and bivalent Omicron-based / original strain

based vaccine, the CIC investigational vaccine candidate, the scope, timing and

outcome of future regulatory filings and actions, including  Novavax' plans to

supplement existing authorizations with data from the additional manufacturing

sites in Novavax' global supply chain, additional worldwide authorizations of

NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential

impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access,

controlling the pandemic and protecting populations, the efficacy, safety and

intended utilization and administration of NVX-CoV2373 are forward-looking

statements. Novavax cautions that these forward-looking statements are subject

to numerous risks and uncertainties that could cause actual results to differ

materially from those expressed or implied by such statements. These risks and

uncertainties include, without limitation, challenges satisfying, alone or

together with partners, various safety, efficacy, and product characterization

requirements, including those related to process qualification and assay

validation, necessary to satisfy applicable regulatory authorities;

unanticipated challenges or delays in conducting clinical trials; difficulty

obtaining scarce raw materials and supplies; resource constraints, including

human capital and manufacturing capacity, on the ability of Novavax to pursue

planned regulatory pathways; challenges meeting contractual requirements under

agreements with multiple commercial, governmental, and other entities; and

those other risk factors identified in the "Risk Factors" and "Management's

Discussion and Analysis of Financial Condition and Results of Operations"

sections of Novavax' Annual Report on Form 10-K for the year ended December 31,

2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the

Securities and Exchange Commission (SEC). We caution investors not to place

considerable reliance on forward-looking statements contained in this press

release. You are encouraged to read our filings with the SEC, available at

www.sec.gov and www.novavax.com, for a discussion of these and other risks and

uncertainties. The forward-looking statements in this press release speak only

as of the date of this document, and we undertake no obligation to update or

revise any of the statements. Our business is subject to substantial risks and

uncertainties, including those referenced above. Investors, potential

investors, and others should give careful consideration to these risks and

uncertainties.

 

Contacts:

Investors

Erika Schultz | 240-268-2022

ir@novavax.com

 

Media

Ali Chartan or Giovanna Chandler | 202-709-5563

media@novavax.com

 

Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

 

Source - Novavax, Inc.