VaxInnate to Present at Cantor Fitzgerald’s Inaugural Healthcare Conference

CRANBURY, NJ – July 1, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology, today announced plans to present a company overview at Cantor Fitzgerald’s Inaugural Healthcare Conference. The presentation by Wayne Pisano, VaxInnate’s president and chief executive officer, will take place on Wednesday, July 8, 2015 at 10:45 am ET at the Le Parker Meridien Hotel in New York City.

VaxInnate’s presentation will include an update of corporate and clinical milestones, including the Company’s recent reallocation of resources to support increased research and development efforts while maintaining momentum on the development of its lead seasonal influenza vaccine candidate, VAX2012Q, which entered a Phase 2 clinical study in June 2015.

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. In June 2015, VaxInnate initiated a Phase 2 study of safety and immunogenicity of VAX2012Q, including an active comparator, Fluzone® Quadrivalent, in healthy adults aged 18-64. Data is expected in the second half of 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 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 Appoints Former CDC Division Chief Thomas Monath to Board of Directors

CRANBURY, NJ, June 17, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology platform, today announced the appointment of Thomas P. Monath, MD to the Company’s board of directors. Dr. Monath is an internationally known virologist and vaccinologist with significant experience in the biotechnology industry and at the Centers for Disease Control and Prevention (CDC).

“It is rare to find someone with such a robust resume in public service and industry. Dr. Monath’s vast experience in epidemiology and vaccinology will be a huge asset to VaxInnate as we progress our pipeline of novel vaccine candidates, including VAX2012Q, our Phase 2 candidate for seasonal influenza,” said Wayne Pisano, VaxInnate’s president and chief executive officer. “In addition to advancing our late-stage candidates, Tom’s experience will also be helpful as we leverage his decades in early stage research and development of vaccines, and move forward in our efforts to identify new infectious disease targets to pursue.”

Dr. Monath currently serves as the chief scientific and chief operating officer of BioProtection Systems, a subsidiary of NewLink Genetics Corporation, where he is leading the development of an Ebola virus vaccine in partnership with Merck. Prior to joining NewLink, Tom held various industry roles at PaxVax Inc., Hookipa Biotech AG, Juvaris Inc., Xcellerex Inc. and Acambis Inc. prior to its acquisition by Sanofi Pasteur. In these roles, he was involved in the development of a broad array of vaccines including those for cholera, influenza, polio, malaria, HIV, anthrax, dengue, Japanese encephalitis, West Nile, yellow fever, Clostridium difficile and smallpox. He is a former partner in the Pandemic and Bio Defense Fund at Kleiner Perkins Caufield & Byers, a leading venture capital firm with a strong life sciences practice. He joined industry following a 20-year career at U.S. Army Medical Research Institute of Infectious Diseases and the CDC’s Division of Vector-Borne Infectious Diseases. Dr. Monath received his undergraduate and medical degrees at Harvard College and Harvard Medical School, respectively; was awarded virology fellowships at the University of Ibadan in Ibadan, Nigeria and Massachusetts General Hospital; and completed residencies in medicine at Peter Bent Brigham Hospital in Boston.

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. In addition, this technology has the potential to enhance vaccine manufacturing by producing 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 well-tolerated 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.

For additional information:
Aline B. Schimmel
Scienta Communications
aschimmel@scientapr.com

Christine C. Mayer
VaxInnate Corporation
info@vaxinnate.com

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 Enhances R&D Program and Strengthens Senior Management Team to Drive Pipeline Development of Current and Potential Targets

VaxInnate Enhances R&D Program and Strengthens Senior Management Team to Drive Pipeline Development of Current and Potential Targets

– Lynda Tussey, PhD, Promoted to Chief Scientific Officer; Senior Appointments and Promotions Announced in R&D, Clinical and Manufacturing –

pressrelease-may13CRANBURY, NJ – May 13, 2015 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough vaccine technology, today announced two strategic promotions and two additions to the senior development team to help drive the growth of the Company’s pipeline, including its lead influenza vaccine candidates.

Lynda Tussey, PhD, has been promoted to chief scientific officer from vice president of research and development, while Bruce Weaver has been named vice president of manufacturing following his time as director of process development. Peter Fusco, PhD, joins the Company as vice president of research and development, and Stephen Haworth, MD, assumes the role of vice president of clinical. Mr. Weaver, Dr. Fusco and Dr. Haworth will join the Company’s senior management team.

VaxInnate also announced today that it has reprioritized resources in research and clinical development to help advance the Company’s preclinical initiatives outside of its lead influenza programs, including vaccines against dengue and Clostridium difficile. Additionally, the Company will increase attention to the identification of new infectious disease targets to further enrich its pipeline. In 2015, VaxInnate also expects to advance VAX2012Q, its lead experimental seasonal influenza vaccine, through Phase 1b into a Phase 2 trial in healthy adults, and commence a Phase 1 study for a pandemic vaccine.

“Dr. Tussey has been an invaluable asset during her time at VaxInnate, with a deep background in immune modulation that she has applied to our proprietary vaccine programs,” commented Wayne F. Pisano, VaxInnate’s president and chief executive officer. “In her new role as chief scientific officer, she will be responsible for developing the long-term clinical growth plan to enrich the Company’s pipeline while also devoting resources to our ongoing influenza, dengue and C. diff programs, and leading VaxInnate’s discovery efforts.”

Peter Fusco, PhD, comes to VaxInnate with over 30 years of experience in vaccinology. During his career, he has played a major role in the development and testing of a wide range of human vaccines, including PharmAthene’s anthrax vaccine candidate, SparVax®; Baxter’s human meningococcal C conjugate vaccine, NeisVac-C™; and North American Vaccine’s licensed DTaP vaccine, Certiv™. Dr. Fusco received his undergraduate training in bacteriology at Rutgers College and his PhD in biophysics and microbiology at the University of Pittsburgh. He has authored over 90 scientific publications and posters, and is named on five U.S. patents.

Stephen Haworth, MD, has more than 25 years of global drug development experience, most recently as chief medical officer of Elusys Therapeutics Inc. Prior to Elusys, Stephen held senior positions in AstraZeneca’s infectious disease unit and Shire Pharmaceuticals’ biologics unit, where he led development of vaccines for seasonal as well as pandemic influenza, pneumococcal disease, and transitional cell carcinoma of the bladder. Stephen’s undergraduate degree from University College, University of London was followed by a Bachelor of Medicine, Bachelor of Surgery (MD equivalent) from the same university.

Bruce Weaver has led Phase 1 cGMP manufacturing efforts during his time at VaxInnate and has developed the high-yielding E. coli fermentation process and purification methods that have become the foundation of the Company’s production process. Prior to his tenure at VaxInnate, Mr. Weaver held positions at Laureate Pharma and Unigene Laboratories where he led their downstream groups. Mr. Weaver received his undergraduate degree in chemical engineering from Bucknell University, and holds master’s degrees from Tufts University and Rutgers University.

“Peter Fusco and Stephen Haworth’s combined experience in global infectious diseases will be a strong addition for us here at VaxInnate, not only as we advance our current clinical programs, but also in the evaluation of new infectious disease targets that may benefit from the reproducibility, reliability and speed of our proprietary vaccine production technology, ” Dr. Tussey added. “Bruce Weaver’s background in recombinant protein vaccine production using our E. coli fermentation and purification methods will be essential to this process. We look forward to employing the significantly expanded depth and creativity of this team as we execute on our lead programs while working to identify additional indications for our pipeline.”

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 been shown to be safe and immunogenic in healthy adults. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic influenza, Clostridium difficile infection 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:

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