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

 

VaxInnate Updates Plans to Advance Lead Vaccine Candidate, VAX2012Q in Elderly

VAX2012Q-graphicCRANBURY, NJ, October 8, 2014 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, provided an update on clinical development plans for the Company’s experimental recombinant quadrivalent vaccine, VAX2012Q. VaxInnate plans to advance VAX2012Q into a Phase 1b/2 study for the prevention of seasonal influenza in elderly individuals by the end of 2014.

“As people age, their immune system’s response to vaccines weakens, making vaccine potency in elderly populations especially challenging. This weakening of the immune system also leaves the elderly at increased risk of viral infection and more serious disease,” commented Wayne Pisano, VaxInnate’s president and chief executive officer. “In prior studies, the recombinant proteins used in our proprietary vaccines have elicited robust immune responses in adults, including elderly. We look forward to examining the immune response generated by VAX2012Q in this more vulnerable elderly population.”

Up to 200 healthy adults age 65-75 years will be enrolled in this multi-center, randomized, double-blind, placebo-controlled, dose-escalating Phase 1b/2 study. VAX2012Q was also assessed in a Phase 1 study in adults 18-40 years of age initiated in March 2014. This Phase 1 study was the subject of an abstract accepted at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and showed that doses up to 18 mcg were generally well tolerated and immunogenic with mild to moderate arm pain as the most common adverse event reported.

“The low-cost, highly scalable manufacturing process we have developed at VaxInnate avoids many of the challenges of conventional vaccine production. Importantly, it also has the potential to respond orders-of-magnitude faster than current vaccine producers can, making VaxInnate’s platform unique and compelling,” remarked Dr. Lynda Tussey, vice president of research and development at VaxInnate.

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 with federal funds from 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.

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 Begins Phase I Clinical Trial to Evaluate Quadrivalent Vaccine for Prevention of Seasonal Flu

VAX2012Q-graphicCRANBURY, NJ, March 19, 2014 – VaxInnate Corporation today announced that enrollment has commenced in a Phase 1 clinical trial to evaluate VAX2012Q, a recombinant quadrivalent vaccine in development for the prevention of seasonal influenza. VaxInnate is a biotechnology firm pioneering a breakthrough technology platform for the development of novel vaccines.

The VAX2012Q clinical trial is being funded in whole with federal funds from 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. The trial, which is taking place at four sites in the United States, will evaluate the safety and immunogenicity of VAX2012Q.

VAX2012Q is a dose escalation study. Up to 320 healthy adults aged 18-40 will receive VAX2012Q by intramuscular injection. The subjects will be evaluated in the clinic 21 days and six months post-vaccination, and followed for one year. The study is expected to yield data that will enable VaxInnate to select the appropriate dose of VAX2012Q for further development. Results are anticipated by the end of 2014.

“We’re pleased to advance VAX2012Q into clinical development with this study, which will enable VaxInnate to optimize the dose of this vaccine,” said Wayne Pisano, President and CEO of VaxInnate. “We believe VAX2012Q has the potential to be an effective and much-needed option for the prevention of seasonal flu, which remains a significant public health problem.”

Seasonal influenza viruses cause mild to severe illness, hospitalizations, and deaths every year in the United States and the rest of the world. Certain populations are at greater risk for serious complications if they contract the flu, including the elderly, children under age five and pregnant women. Others at high risk of developing serious flu-related complications are people with certain health conditions, among them asthma, chronic lung diseases, heart disease, diabetes and weakened immune systems due to diseases such as cancer and HIV infection. Annual vaccination is the best way to prevent the flu.

Promising 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.

More 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. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile and dengue. VaxInnate’s technology has the potential to dramatically improve the potency, manufacturing capacity and cost-effectiveness of vaccines.

In 2011, Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), awarded a contract to VaxInnate worth up to $196 million to fund the development of seasonal and pandemic flu vaccines using its recombinant technology.

VaxInnate has already generated positive Phase 1, and in some instances Phase 2, clinical data for its monovalent seasonal vaccine components as well as its prototypic pandemic 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.

For more information about VaxInnate, including a video that explains the company’s technology platform,  please visit the new website at https://vaxinnate.comm

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Janet Skidmore
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