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“deltaFLU

Universal Influenza Vaccine

For Broad Protection and Superior Efficacy
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Vivaldi Biosciences is developing its deltaFLU universal influenza vaccine to protect against all influenza strains – seasonal and pandemic – for all ages, from infants to seniors.

deltaFLU is an advanced, self-adjuvanting influenza vaccine, administered as a nasal spray. Immunization with deltaFLU is simple, convenient and pain-free.

 
 
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UNIVERSAL PROTECTION

deltaFLU is a radical advance towards the first truly universal influenza vaccine. A single dose of deltaFLU shows potential to protect against a broad range of influenza type A and B strains. Studies in human volunteers show the deltaFLU vaccine approach generates immunity to widely different influenza viruses – diverse strains that cause seasonal flu, and even an influenza strain with pandemic potential (A/H5N1 “bird flu”).

Recent studies in the ferret model take these striking clinical results a step further, showing deltaFLU protects against “drifted” influenza strains exhibiting a decade’s worth of accumulated genetic changes, and even protects against a strain so genetically altered it’s considered “shifted.” Such shifted strains are the source of flu pandemics.

With a unique self-adjuvant effect achieved by inducing interferon, deltaFLU generates a rapid and robust immune response. Administered as a gentle nasal spray, deltaFLU launches its protective effect in the nasal passages to disable incoming influenza viruses, and establishes long-lasting and broad protection from circulating T cells and cross-reactive antibodies.

Universal Protection

With its unique mode of action, deltaFLU achieves a robust and broad immune response to multiple influenza strains

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UNIVERSAL PROTECTION

deltaFLU is a radical advance towards the first truly universal influenza vaccine. A single dose of deltaFLU shows potential to protect against a broad range of influenza type A and B strains. Studies in human volunteers show the deltaFLU vaccine approach generates immunity to widely different influenza viruses – diverse strains that cause seasonal flu, and even an influenza strain with pandemic potential (A/H5N1 “bird flu”).

Recent studies in the ferret model take these striking clinical results a step further, showing deltaFLU protects against “drifted” influenza strains exhibiting a decade’s worth of accumulated genetic changes, and even protects against a strain so genetically altered it’s considered “shifted.” Such shifted strains are the source of flu pandemics.

With a unique self-adjuvant effect achieved by inducing interferon, deltaFLU generates a rapid and robust immune response. Administered as a gentle nasal spray, deltaFLU launches its protective effect in the nasal passages to disable incoming influenza viruses, and establishes long-lasting and broad protection from circulating T cells and cross-reactive antibodies.

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INNOVATIVE PRODUCTION

We’ve developed and implemented a proprietary high-yield, high-efficiency process for producing deltaFLU using Vero cells as the production substrate. Our Vero cell system is fast, efficient and economical. Vero cells are an advantageous production platform − they are widely used for manufacture of licensed vaccines, have a solid regulatory track record, and eliminate the problem of antigenic mutations caused by production in eggs, the most widely used substrate for production of licensed influenza vaccines.

deltaFLU is composed of selected influenza type A and B vaccine strains genetically modified by deletion of the gene for NS1 and optimized for high growth and efficient production in Vero cells. We’re able to generate deltaFLU vaccine strains in as little as one week. And we’re able to produce the finished deltaFLU vaccine product in just 7 weeks. Traditional egg-based production can take up to 6 months.

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Our 7-week production timeline is a game-changer in the event of a pandemic, and provides an important competitive advantage in the seasonal influenza vaccine market.

Our Vero cell system uses serum-free media and single-use bioreactors. The streamlined process and one-step purification protocol enhance the efficiency and ensure a potent and pure vaccine product. Our system can be scaled to meet the demand for broad protection against seasonal influenza, and the challenge of rapidly producing hundreds of millions of doses in the face of an emerging influenza pandemic. Rapid vaccine strain generation and production enable shifting from commercial production of deltaFLU for the seasonal influenza market to surge production of deltaFLU for pandemic influenza. With its nasal spray dosage form, immunization with deltaFLU is efficient and well suited to mass use in a pandemic situation.

Innovative Production 

deltaFLU vaccines can be delivered with unprecedented speed using our cell-based production system

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INNOVATIVE PRODUCTION

We’ve developed and implemented a proprietary high-yield, high-efficiency process for producing deltaFLU using Vero cells as the production substrate. Our Vero cell system is fast, efficient and economical. Vero cells are an advantageous production platform − they are widely used for manufacture of licensed vaccines, have a solid regulatory track record, and eliminate the problem of antigenic mutations caused by production in eggs, the most widely used substrate for production of licensed influenza vaccines.

deltaFLU is composed of selected influenza type A and B vaccine strains genetically modified by deletion of the gene for NS1 and optimized for high growth and efficient production in Vero cells. We’re able to generate deltaFLU vaccine strains in as little as one week. And we’re able to produce the finished deltaFLU vaccine product in just 7 weeks. Traditional egg-based production can take up to 6 months.

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Our 7-week production timeline is a game-changer in the event of a pandemic, and provides an important competitive advantage in the seasonal influenza vaccine market.

Our Vero cell system uses serum-free media and single-use bioreactors. The streamlined process and one-step purification protocol enhance the efficiency and ensure a potent and pure vaccine product. Our system can be scaled to meet the demand for broad protection against seasonal influenza, and the challenge of rapidly producing hundreds of millions of doses in the face of an emerging influenza pandemic. Rapid vaccine strain generation and production enable shifting from commercial production of deltaFLU for the seasonal influenza market to surge production of deltaFLU for pandemic influenza. With its nasal spray dosage form, immunization with deltaFLU is efficient and well suited to mass use in a pandemic situation.

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CLINICAL TRIALS

We’ve successfully evaluated deltaFLU vaccines in Phase 1 and 2 clinical trials involving a total of 245 volunteers. These studies show deltaFLU vaccines are safe and generate a qualitatively and quantitatively different immune response from the responses that other influenza vaccine approaches can achieve. deltaFLU induces an immune response that is both broader and more potent.

Broader: Clinical study volunteers immunized with deltaFLU generated antibodies with broad cross-neutralizing activities in the nasal passages and blood serum, showing that deltaFLU induces antibodies that act against unmatched influenza strains. For example, in a Phase 1 clinical study we showed that immunization with deltaFLU induced antibodies that neutralize influenza viruses of unrelated subtypes: antibodies generated by a deltaFLU vaccine of influenza subtype A/H1N1 neutralized influenza viruses of the A/H3N2 and A/H5N1 subtypes (heterosubtypic cross-neutralization).

More Potent: A comparison of Phase 1 results for deltaFLU with published clinical data shows the superior immune response achieved by deltaFLU versus other vaccine approaches for protection against influenza H5N1 (the “bird flu” strain). After a single dose of deltaFLU, 75% of volunteers achieved seroconversion (a key measure of antibody response) while other vaccine approaches, including adjuvanted vaccines, achieved just 5% to 58% seroconversion.

We’re planning a Phase 2 challenge study to demonstrate under controlled conditions that deltaFLU protects against intentional infection with an unmatched influenza strain. This study builds on the success of our four completed clinical trials, and our recent study in a nonclinical model showing that a single dose of deltaFLU provides broad protection against unmatched strains – distantly drifted influenza strains, and even a shifted influenza strain – while a leading licensed influenza vaccine lacked protection.

Clinical Trials

With 4 completed studies confirming the safety and immune response in humans, deltaFLU is ready for the next stage of clinical development

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CLINICAL TRIALS

We’ve successfully evaluated deltaFLU vaccines in Phase 1 and 2 clinical trials involving a total of 245 volunteers. These studies show deltaFLU vaccines are safe and generate a qualitatively and quantitatively different immune response from the responses that other influenza vaccine approaches can achieve. deltaFLU induces an immune response that is both broader and more potent.

Broader: Clinical study volunteers immunized with deltaFLU generated antibodies with broad cross-neutralizing activities in the nasal passages and blood serum, showing that deltaFLU induces antibodies that act against unmatched influenza strains. For example, in a Phase 1 clinical study we showed that immunization with deltaFLU induced antibodies that neutralize influenza viruses of unrelated subtypes: antibodies generated by a deltaFLU vaccine of influenza subtype A/H1N1 neutralized influenza viruses of the A/H3N2 and A/H5N1 subtypes (heterosubtypic cross-neutralization).

More Potent: A comparison of Phase 1 results for deltaFLU with published clinical data shows the superior immune response achieved by deltaFLU versus other vaccine approaches for protection against influenza H5N1 (the “bird flu” strain). After a single dose of deltaFLU, 75% of volunteers achieved seroconversion (a key measure of antibody response) while other vaccine approaches, including adjuvanted vaccines, achieved just 5% to 58% seroconversion.

We’re planning a Phase 2 clinical challenge study to demonstrate under controlled conditions that deltaFLU protects against intentional infection with an unmatched influenza strain. This study builds on the success of our four completed clinical trials, and our recent study in a nonclinical model showing that a single dose of deltaFLU provides broad protection against unmatched strains – distantly drifted influenza strains, and even a shifted influenza strain – while a leading licensed influenza vaccine lacked protection.

 
“The
deltaFLU Difference”
 
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deltaFLU is the only vaccine in clinical development based on deletion of the influenza NS1 gene. Removing this influenza virulence gene gives deltaFLU both its unique mode of attenuation and its highly effective mechanism of action. Lacking NS1, deltaFLU rapidly induces interferon, a key component of the immune response to viral infection.

Deletion of NS1 achieves two highly advantageous properties of deltaFLU:

Delivered into the nasal passages in a gentle spray, deltaFLU introduces to the immune system natural viral antigens that stimulate multiple components of the immune system to achieve a broadly protective immune response. The effect is similar to infection with a circulating influenza strain, but with a crucial difference: deltaFLU vaccine strains are replication-deficient. Because of this, deltaFLU strains cannot cause disease and do not produce viral progeny. Individuals immunized with deltaFLU do not shed the vaccine virus. These are important safety aspects of the deltaFLU approach, and significant advantages over live vaccines that are able to replicate.

deltaFLU vaccine strains can’t fight off the body’s interferon response because unlike naturally occurring influenza viruses, they lack the ability to produce NS1. As a result, deltaFLU rapidly induces high levels of interferon and IgA antibodies in the linings of the nasal passages, creating a first line of defense against circulating disease-causing influenza viruses directly at their point of entry. This potent interferon response generates a self-adjuvant effect that activates a broadly protective systemic immune response in the form of serum antibodies, T cells, and T cell-based memory to viral infection.

Rapid and robust interferon induction – and interferon’s self-adjuvant effect – are unique to deltaFLU.

 
 
 
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