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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Media contact:
Janet Skidmore
Office:  215-658-4915
Mobile:  215-429-2917
skidmorecomm@earthlink.net

VaxInnate Receives $2.1 million from New Jersey’s Technology Business Tax Certificate Transfer Program

EDA LogoCRANBURY, NJ, January 28, 2014 – VaxInnate Corporation, a biotechnology firm pioneering a breakthrough technology platform for the development of novel vaccines, announced today that it has received $2.1 million in non-dilutive financing through New Jersey’s Technology Business Tax Certificate Transfer (NOL) Program.

This is the fifth year that VaxInnate has been selected to participate in the program, a state initiative designed to spur innovation and job creation by assisting promising early-stage biotechnology, life sciences and technology firms.  VaxInnate will use the funds to continue its research and development of vaccines to prevent infectious diseases, including seasonal and pandemic flu, Clostridium difficile and dengue.

VaxInnate is one of 54 companies to benefit from the competitive program, which distributes about $60 million annually to companies by permitting them to sell New Jersey tax losses and/or research and development (R&D) tax credits in order to raise cash to finance growth and operations.  Eligibility is determined by the NJ Economic Development Authority (NJEDA), the NJ Division of Taxation determines the value of the available tax benefits, and the NJ Commission on Science and Technology evaluates the technology.

“VaxInnate is pleased to participate in this program for the fifth year and thankful to the New Jersey Economic Development Authority for its consideration.  We also want to thank BioNJ for its ongoing support,” said Wayne Pisano, President and CEO of VaxInnate. “Programs like this one help make it possible for scientific advancements to take place here in the Garden State, and we have every confidence that VaxInnate will contribute in that arena.”

New Website Launched

In addition to its selection for the NOL funding, VaxInnate began 2014 with the launch of a new corporate website – www.vaxinnate.com.  The website features a wealth of visuals, including a three-minute video of CEO Pisano discussing VaxInnate’s technology platform and vaccine development programs.  The website also includes VaxInnate’s product pipeline and explanations of the company’s proprietary vaccine technology and R&D capabilities.

Details are also included about ongoing collaborations with government and private partners, including the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. National Institutes of Health (NIH).

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 flu, dengue, and Clostridium difficile. 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 over five years 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. These vaccines have demonstrated excellent potency in the elderly population- a group that is typically less responsive to influenza vaccines.

For more information about VaxInnate, please visit the new website at https://vaxinnate.comm

# # #

Media contact:
Janet Skidmore
Office:  215-658-4915
Mobile:  215-429-2917
skidmorecomm@earthlink.net

 

Two New Executives Join VaxInnate Management Team

Vice Presidents of Business Development and Regulatory Affairs to advance NJ biotech company’s vaccine development programs

Christine_Katalain1CRANBURY, NJ, September 4, 2012 — VaxInnate Corporation today announced the expansion of its executive management team with the addition of Christine Mayer as Vice President of Business Development and Katalin Abraham as Vice President of Regulatory Affairs. VaxInnate is a biotechnology firm pioneering breakthrough technology for the development of novel vaccines.

Mayer, who is the former Senior Vice President of Business Development at Biovail Pharmaceuticals, will use her experience in collaborations and partnerships to help VaxInnate achieve its strategic vision. Abraham, who previously served as Director of Regulatory Affairs at GlaxoSmithKline (GSK), where she was responsible for pandemic and adjuvanted influenza vaccines, becomes VaxInnate’s primary liaison with regulatory agencies.

Both will play integral roles in advancing the development of VaxInnate’s vaccines for three key infectious diseases. These include vaccines for seasonal and pandemic flu; dengue fever, a growing disease that affects millions globally; and Clostridium difficile, the cause of increasing disease and death, primarily among elderly populations in developed countries.

“With our proprietary vaccine technology and the funding from our contract with the U.S. government to develop flu vaccines in place, we are relying on the skill and dedication of our management team to achieve our strategic vision for VaxInnate,” said Wayne Pisano, President and CEO. “Chris and Kati join VaxInnate at a most opportune time and we are confident that they will play key roles in helping us advance our novel vaccine programs through clinical trials to the marketplace.”

Prior to her role at Biovail, Mayer served in senior positions at sanofi aventis and Johnson & Johnson. She received a bachelor’s degree from Glassboro State College and a master’s degree from Rutgers University.

Before joining GSK, Abraham held senior positions at Merck & Co, Inc. and the former Centocor, now known as Janssen Biotech, Inc. She is a graduate of the University of Pennsylvania.

 


About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic flu, dengue and malaria.

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 over five years to fund the development of seasonal and pandemic flu vaccines using recombinant technology.

VaxInnate has already generated positive Phase I and Phase II clinical data for its flu vaccines. These prototype vaccines also demonstrated superior potency in elderly subjects. For more information about VaxInnate, please visit https://vaxinnate.com.

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Contact:    

Janet Skidmore
Office:  215-658-4915
Mobile:  215-429-2917
skidmorecomm@earthlink.net

 

 

Lt. Governor Kim Guadagno Visits VaxInnate

On Statewide Tour of Life Sciences Firms

LtGovernor-and-WayneCRANBURY, NJ, June 27, 2012 – Lt. Governor Kim Guadagno visited the headquarters of VaxInnate Corporation today, where she continued her statewide tour to support the expansion of New Jersey’s life sciences companies and lauded the biotechnology company for its commitment to the state and efforts to develop novel vaccines.

“The Christie Administration has made it a priority to improve New Jersey’s business climate to ensure industries like the life sciences and leading companies like VaxInnate increase their investment here and grow quality jobs for our state’s residents,” Lt. Governor Guadagno said. “We are happy to have the opportunity to work with VaxInnate as it continues to grow and prosper in the Garden State.”

VaxInnate is a biotechnology firm applying proprietary technology to the development of novel vaccines for three key infectious diseases. These include influenza; dengue fever, a growing disease that affects millions globally; and Clostridium difficile, the cause of increasing disease and death, primarily among the elderly in developed countries. In the area of influenza, VaxInnate is working with the U.S. government on vaccines for pandemic and seasonal influenza, including avian or bird flu, a global public health priority.

During her visit to VaxInnate’s Cranbury headquarters, Lt. Governor Guadagno said the nation was looking to New Jersey’s life sciences sector for new vaccines and treatments for many common diseases, especially as the population ages. She noted that New Jersey offers a convenient location, a highly skilled and educated workforce, excellent transportation, and a positive business climate.

Vaxinnate executives talked with the Lt. Governor about the company’s plans for future growth in New Jersey, including expansion of existing laboratories and offices and the hiring of additional employees. The company has 56 employees today.

CEO Wayne Pisano also outlined the company’s potential interest in a vaccine manufacturing facility to meet U.S. and worldwide needs. VaxInnate currently outsources manufacturing to contractors in other states and countries.

“We’re honored to have Lt. Governor Guadagno visit us, tour our facilities, and discuss VaxInnate’s promising research on vaccines, which prevent death and disability and reduce healthcare costs,” Pisano said. “We thank her for her leadership in promoting the life sciences industry and for her interest in helping VaxInnate grow and prosper in New Jersey, our home for the past eight years.”

 


About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic flu, dengue and malaria.

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 over five years to fund the development of seasonal and pandemic flu vaccines using recombinant technology.

VaxInnate has already generated positive Phase I and Phase II clinical data for its flu vaccines. These prototype vaccines also demonstrated superior potency in elderly subjects. For more information about VaxInnate, please visit https://vaxinnate.com.

###

Contact:    

Janet Skidmore
Office:  215-658-4915
Mobile:  215-429-2917
skidmorecomm@earthlink.net

 

VaxInnate Names Wayne Pisano as its New CEO

Former CEO of Sanofi Pasteur brings 30 years of pharmaceutical and vaccine leadership to NJ biotech firm

CRANBURY, NJ, April 2, 2012 – VaxInnate Corporation today announced that Wayne Pisano has joined the Company as President and Chief Executive Officer (CEO), and become a member of the Board. Pisano was formerly the President and CEO of sanofi pasteur, a division of sanofi-aventis Group and the world’s largest vaccine business.

“I’m very excited to join VaxInnate, a company that’s poised to become a significant player in the flu vaccine arena, thanks to its game-changing vaccine technology,” Pisano said. “VaxInnate is very well positioned, given its contract with the U.S. government to develop flu vaccines. In addition, VaxInnate’s dengue vaccine is showing great promise in preclinical studies and is expected to enter Phase I trials next year.”

“Throughout his 30-year career, Wayne has demonstrated his development and commercialization skills at both vaccine and pharmaceutical companies,” said Philippe Chambon, MD, PhD, a VaxInnate Board member and Managing Director of New Leaf Venture Partners. “Wayne has a sincere commitment to vaccines and their unquestionable value in preventing disease. We’re delighted to welcome Wayne to VaxInnate and to our Board, and look forward to having him lead the Company at this critical stage in its development.”

Pisano began his career with sanofi, one of the world’s largest pharmaceutical companies, in 1997. He held a series of progressively more senior positions at sanofi pasteur over the next two decades, culminating in his appointment as division president and CEO in 2007. He retired from that role in 2011.

During his tenure at sanofi, Pisano was recognized as a global leader in vaccine development, production and sales. Under his leadership, more than one billion doses of sanofi pasteur’s lifesaving vaccines were administered annually to 500 million people around the world, representing more than 25% of the world’s vaccine market. In addition to his responsibilities at sanofi, Pisano served on the supervisory board of Sanofi Pasteur MSD, a 50-50 joint venture with Merck & Co., Inc. that markets and distributes vaccines in Europe.

Pisano also spent a significant portion of his career in the pharmaceutical division of Novartis (Sandoz). He holds a bachelor’s degree in biology from St. John Fisher College, Rochester, New York, and a Master of Business Administration from the University of Dayton, Ohio. He is a resident of Asbury, NJ.

Pisano replaces Thomas Hofstaetter, PhD, who retired at the end of 2011 after two years as president and CEO of VaxInnate and a member of the Board.

 


About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic flu, dengue and malaria.

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 over five years to fund the development of seasonal and pandemic flu vaccines using recombinant technology.

VaxInnate has already generated positive Phase I and Phase II clinical data for its flu vaccines. These prototype vaccines also demonstrated superior potency in elderly subjects. For more information about VaxInnate, please visit https://vaxinnate.com.

###

Contact:    

Janet Skidmore
Office:  215-658-4915
Mobile:  215-429-2917
skidmorecomm@earthlink.net