March 01, 2015 6:37 PM ET

Biotechnology

Company Overview of VaxInnate, Inc.

Company Overview

VaxInnate, Inc., a biotechnology company, engages in the development and production of vaccines for pandemic and seasonal influenza diseases. Its products include Flagellin.HuHA and flagellin.AvHA, which are fusion proteins linking a potent immune stimulator, the bacterial protein flagellin, with immunoprotective domain of viral hemagglutinin. The company's products are used in the treatment of various diseases, including bacterial, viral, and parasitic infections. VaxInnate, Inc. was founded in 2002 and is headquartered in Cranbury, New Jersey.

3 Cedar Brook Drive

Suite 1

Cranbury, NJ 08512

United States

Founded in 2002

Phone:

609-860-2260

Fax:

609-860-2290

Key Executives for VaxInnate, Inc.

Chief Executive Officer, President and Director
Age: 59
Scientific Founder
Scientific Founder
Chief Financial Officer
Age: 53
Vice President of Business Development
Age: 55
Compensation as of Fiscal Year 2014.

VaxInnate, Inc. Key Developments

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

VaxInnate Corporation 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. 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. 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.

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

VaxInnate Corporation 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. 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.

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

VaxInnate Corporation 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. 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. 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.

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