VaxInnate Advances Quadrivalent Seasonal Influenza Vaccine Candidate, VAX2012Q, into Phase 2 Study

VaxInnate Advances Quadrivalent Seasonal Influenza Vaccine Candidate, VAX2012Q, into Phase 2 Study

Top-line results expected in second half of 2015

VAX2012Q-graphic-300x300Cranbury, NJ, June 3, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, today announced the initiation of a double-blind, randomized, active comparator controlled Phase 2 study to evaluate the safety and immunogenicity of its VAX2012Q quadrivalent seasonal influenza vaccine candidate.

The active comparator in the study is Fluzone® Quadrivalent, a commercially available vaccine. The VAX2012Q clinical trial is being fully funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSO100201100011C.

“We believe our proprietary recombinant vaccine production technology offers significant benefits over traditional manufacturing methods, including reliability and cost effectiveness,” commented Wayne Pisano, VaxInnate’s president and chief executive officer. “In addition, our technology also has the important benefit of speed, which can be essential when reacting to unexpected strain drifts, as we witnessed earlier in 2015. The initiation of this Phase 2 study represents another important milestone on our path to commercialization, and we look forward to seeing top-line results later this year.”

VaxInnate plans to enroll up to 450 healthy adults 18-64 years of age at six sites in the United States. Study participants will receive, in a blinded fashion, a single dose of vaccine, either VAX2012Q at 2 mcg or 3 mcg per component or the standard 15 mcg per component dose of Fluzone® Quadrivalent. The study will measure immune response to each of the four components of VAX2012Q. Additionally, VaxInnate will monitor immunogenicity and safety after 21 and 90 days, and participants will be followed for one year following their vaccination to assess long-term safety. The Company expects to complete patient enrollment by mid-2015 and report preliminary results in the second half of the year.

This Phase 2 study follows the successful conclusion of a Phase 1 trial of VAX2012Q in healthy adults 18-40 years of age in which doses as low as 2 mcg per component elicited robust immune responses to each of the four vaccine components. The vaccine was generally well-tolerated, with mild to moderate arm pain the most commonly reported adverse event.

Powerful Vaccine Technology Platform

VaxInnate’s technology platform is based on proprietary toll-like receptor (TLR) technology, which genetically fuses vaccine antigens to the bacterial protein flagellin, a TLR5 agonist. These fusion proteins potentiate the immune response through sequential triggering of the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in extremely rapid timeframes, with very low infrastructure costs.

About VaxInnate

VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have been shown to be safe and immunogenic in clinical studies. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are largely supported under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.

CONTACT:

Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com

Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

VaxInnate to Present at Needham & Company 14th Annual Healthcare Conference

CRANBURY, NJ – April 7, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology, today announced plans to present at the Needham & Company 14th Annual Healthcare Conference. The presentation by Wayne Pisano, VaxInnate’s president and chief executive officer, will take on place Wednesday, April 15, 2015 at 10:00 am at The Westin Grand Central Hotel in New York City, NY.

The Company presentation will include an update of corporate and clinical milestones, including the clinical status of VAX2012Q, VaxInnate’s investigational quadrivalent seasonal influenza vaccine, as well as the recent extension of VaxInnate’s contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), which funds the development of both seasonal quadrivalent and pandemic influenza vaccine candidates.

About VAX2012Q
VAX2012Q is VaxInnate’s investigational recombinant quadrivalent seasonal influenza vaccine. Each vaccine component is fused to a flagellin protein, which acts as a toll-like receptor (TLR) ligand. The TLR class of proteins is known to activate the innate immune system, which in turn enhances the adaptive immune response to vaccines. In a Phase 1 study of 316 healthy adults aged 18-40, doses of VAX2012Q as low as 2 mcg per component were shown to be immunogenic, with mean seroprotection rates exceeding 90% for each of the four vaccine components at the day 21 clinic visit. The vaccine was generally well-tolerated, with mild to moderate arm pain the most commonly reported adverse event. VaxInnate is planning to initiate a Phase 2 study of safety and immunogenicity of VAX2012Q, including an active comparator in healthy adults aged18-64 later this year.

Powerful Vaccine Technology Platform
VaxInnate’s technology platform is based on proprietary toll-like receptor (TLR) technology, which potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in rapid timeframes, with very low infrastructure costs.

About VaxInnate
VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have demonstrated excellent immunogenicity in the elderly population, a group that is typically less responsive to influenza vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are significantly funded under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.

For additional information:
Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com

VaxInnate Receives Extension of Contract from BARDA for Development of Seasonal and Pandemic Influenza Vaccines

– Allows for Non-Dilutive Funding of $53 Million –

CRANBURY, NJ – February 17, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology, today announced that it has executed a contract modification with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) to extend the base period of its current contract (HHSO100201100011C) through February 2016. This extension was granted by the government following completion of an In Process Review (IPR) based on the Company’s milestone performance to date. It allows for the use of approximately $53 million of remaining funds from the base period to be applied to the development of both the seasonal quadrivalent and pandemic influenza vaccine candidates. VaxInnate was originally awarded the contract with BARDA in February 2011.

“We are committed to identifying, wherever possible, non-dilutive financing to drive our development programs forward,” commented Wayne Pisano, VaxInnate’s president and chief executive officer. “We appreciate the continued support of BARDA and look forward to advancing our seasonal and pandemic influenza programs. That includes our planned Phase 2 study of VAX2012Q in individuals aged 18-64 starting in 2015, and our planned Phase 1 and 2 studies of our pandemic vaccine candidate.”

About VAX2012Q

VAX2012Q is an investigational seasonal influenza vaccine comprised of four strains that are each fused to a flagellin protein, which acts as a toll-like receptor (TLR) ligand. The TLR class of proteins is known to activate the innate immune system, which in turn enhances the adaptive immune response to vaccines. In a Phase 1 study of 316 healthy adults aged 18-40, doses of VAX2012Q as low as 2 mcg per component were shown to be immunogenic, with mean seroprotection rates exceeding 90% for each of the four vaccine components at the day 21 clinic visit. The vaccine was generally well-tolerated, with mild to moderate arm pain the most commonly reported adverse event. VAX2012Q is currently enrolling healthy adults aged 65-75 in a double-blind, randomized, placebo-controlled Phase 1b/2 study.

Powerful Vaccine Technology Platform

VaxInnate’s technology platform is based on proprietary toll-like receptor (TLR) technology, which potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in rapid timeframes, with very low infrastructure costs.

About VaxInnate

VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have demonstrated excellent immunogenicity in the elderly population, a group that is typically less responsive to influenza vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are significantly funded under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.

For additional information:
Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com

VaxInnate Initiates Phase 1b/2 Clinical Trial of Quadrivalent Seasonal Influenza Vaccine Candidate, VAX2012Q, in Elderly

– Study to assess safety and immunogenicity in high-priority, at-risk population; top-line results expected in second quarter of 2015 –

VAX2012Q-graphicCRANBURY, NJ, December 8, 2014 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, today announced the initiation of a double-blind, randomized, placebo-controlled Phase 1b/2 study of VAX2012Q in healthy adults 65-75 years of age.

VAX2012Q is the Company’s seasonal quadrivalent influenza vaccine candidate, which incorporates a bacterial flagellin protein designed to enhance the adaptive immune response to the vaccine. This Phase 1b/2 study will evaluate the vaccine’s safety and immunogenicity in this elderly population. The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, has funded the production of VAX2012Q for use in this clinical study under contract No. HHSO100201100011C.

“We believe our novel, differentiated vaccine platform and production scalability is particularly well-suited to develop vaccines for the elderly, whose immune systems typically require greater stimulation, often in the form of increased antigen, to generate a protective response. In this seasonal influenza trial, we will evaluate several doses of VAX2012Q to determine the dose of antigen for future development, and expect top-line data in the second quarter of 2015,” commented Wayne Pisano, VaxInnate’s president and chief executive officer.

“Traditional egg-based vaccine manufacturers have been historically challenged to produce adequate supply as influenza vaccine demand grows globally, and the added increase in antigen needed for a high-dose elderly product further taxes production,” Pisano continued. “We believe our recombinant manufacturing technology and the dose-sparing attributes of our vaccine will allow us to produce VAX2012Q in significantly greater quantities and in less time than is possible with current vaccine production methods, which will give us a strong advantage in this segment of the market.”

VAX2012Q is comprised of four seasonal influenza strains, each fused to a flagellin protein, which acts as a toll-like receptor (TLR) ligand. The TLR class of proteins is known to activate the innate immune system, which in turn enhances the adaptive immune response to vaccines. In a previous clinical study, VAX125, a vaccine comprised of one seasonal influenza H1N1 strain, was shown to elicit a robust immune response in the elderly.[1]

This Phase 1b/2 study will enroll up to 200 healthy adults 65-75 years of age, who will be administered either VAX2012Q or placebo. In addition to safety, which is the trial’s primary objective, the study will also assess the dose levels necessary to produce a robust immune response in the majority of study participants. Individuals will be monitored for one year following their vaccination to assess long-term safety.

VAX2012Q recently reported positive top-line results from a Phase 1 study of 316 healthy adults 18-40 years of age, showing that doses as low as 2 mcg per component were immunogenic, with mean seroprotection rates exceeding 90% for each of the four vaccine components at the day 21 clinic visit. The vaccine was generally well-tolerated, with mild to moderate arm pain the most commonly reported adverse event.

Powerful Vaccine Technology Platform                  

VaxInnate’s technology platform is based on proprietary toll-like receptor (TLR) technology, which potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in extremely rapid timeframes, with very low infrastructure costs.

About VaxInnate

VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have demonstrated excellent immunogenicity in the elderly population, a group that is typically less responsive to influenza vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are significantly funded under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.

For additional information:

Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com

[1] Taylor, DN et al. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza–flagellin fusion vaccine (VAX125, STF2.HA1 SI). J.Vaccine; 29 (2011) 4897–4902.

VaxInnate Quadrivalent Seasonal Influenza Vaccine Candidate, VAX2012Q, Meets Phase 1 Seasonal Influenza Endpoints

– Top-Line Seroprotection Rates Exceed 90% in each of Four Vaccine Components; VAX2012Q to Proceed into Phase 2 Evaluation in 2015 –

VAX2012QCRANBURY, NJ, November 11, 2014 – VaxInnate Corporation, a biotechnology firm pioneering next-generation vaccine technology, announced today that enrollment has concluded in the Phase 1 study of the Company’s experimental recombinant quadrivalent seasonal influenza vaccine, VAX2012Q. Top-line results showed that doses as low as 2 mcg per component were immunogenic, with mean seroprotection rates exceeding 90% for each of the four vaccine components at the day 21 clinic visit. VAX2012Q was generally well tolerated, with mild to moderate arm pain the most commonly reported adverse event. Complete study results will be submitted for future publication.

“VAX2012Q continues to show great promise as a seasonal influenza vaccine in adults,” commented Dr. Lynda Tussey, vice president of research and development at VaxInnate. “Based on these top-line results, and pending the completion of our planned Phase 1b/2 study in elderly individuals that will begin later this month, we expect to advance VAX2012Q into a Phase 2 study in healthy adults 18 years of age and older in 2015. This next stage of clinical development will confirm the VAX2012Q dose in adult and elderly individuals, and will support further development and pursuit of licensure.”

This Phase 1 trial enrolled 316 healthy adults aged 18-40 who were each evaluated for vaccine tolerability and immune response at 21 days post-vaccination. Study participants will be monitored for one year following their vaccination to assess long-term safety. The trial was funded under Contract No. HHSO100201100011C from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

Wayne Pisano, VaxInnate’s president and chief executive officer, commented, “These immunogenicity results, combined with our advanced recombinant technology, will ensure reliability of supply and the ability to manufacture vaccine rapidly – potentially reducing total production times from the typical six-to-nine month turnaround to just three months.”

“We believe this represents a significant value considering that the demand in the U.S. alone has increased to nearly 150 million doses annually. With this growing demand and given that most influenza immunizations occur in an 8-week period, current manufacturing technologies and capacities have historically struggled to keep up,” Pisano continued. “And with the recent recommendation to add a 4th influenza strain to the seasonal vaccine, there is even greater pressure on the current technologies and manufacturing capacities.  We believe that VAX2012Q and our recombinant manufacturing technology have strong commercial potential in this market, and look forward to reporting additional data from our upcoming studies in 2015.”

Powerful Vaccine Technology Platform                  

VaxInnate’s technology platform is based on proprietary Toll-like Receptor (TLR) technology, which potentiates the immune response. The TLR technology genetically fuses vaccine antigens to the bacterial protein flagellin, and this sequentially triggers the innate and adaptive immune systems. Using this technology, vaccines can be produced using low-cost, highly scalable recombinant DNA techniques, thus avoiding many of the challenges of conventional vaccine production. This technology has the potential for production of significantly greater quantities of vaccine in extremely rapid timeframes, with very low infrastructure costs.

About VaxInnate

VaxInnate is a privately held biotechnology company in Cranbury, NJ that is pioneering a breakthrough technology platform for use in developing novel and proprietary vaccines. Influenza vaccines manufactured using this technology have demonstrated excellent immunogenicity in the elderly population, a group that is typically less responsive to influenza vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s ongoing studies of seasonal and pandemic flu vaccines are significantly funded under Contract No. HHSO100201100011C with the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS).

To learn more about VaxInnate and to explore the company’s technology platform, please visit the website at www.vaxinnate.com.

For additional information:

Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com