Inovio Pharmaceuticals Acquires Needle-Free Injection Technology to Advance Strategy for Next-Generation Vaccines

Inovio Pharmaceuticals, Inc. recently announced it has signed a definitive agreement to acquire all of Bioject Medical Technologies Inc.’s assets, including pioneering needle-free jet injection technology, devices, and intellectual property. Inovio will pay Bioject $5.5 million in cash and stock.

Inovio will advance an integrated non-invasive delivery device combining Bioject’s jet injection technology with Inovio’s new needle-free, skin-surface electroporation (EP) technology. The company’s goal is to facilitate preventive immunization using its DNA vaccines against critical infectious diseases with unmet needs in large populations. Bioject’s needle-free devices, which use high- pressure gas or springs to propel liquid medicine into skin, have demonstrated desirable utility, safety, and tolerability attributes in animals and humans. Under a prior research agreement, Inovio assessed this technology with its new EP delivery system and generated compelling antigen expression and immune responses in animals.

Injecting DNA immunotherapies into tissue alone, irrespective of the injection method, has not generated potent immune responses in clinical studies – DNA immunotherapies must enter cells of the tissue to enable their immune-activating capabilities, which is limited using syringe or jet injection alone. One of two pillars in Inovio’s success in achieving clinically relevant efficacy with induced immune responses is its proprietary EP technology enabling delivered DNA to be transported into the cells. Inovio’s compelling data have to date been achieved using intramuscular needle-based injection and EP, which is well-suited for treating cancers and infectious diseases. Achieving preventive immunization using DNA vaccines against challenging infectious diseases in large populations will also require EP delivery. It would also benefit significantly from a combined jet injection/electroporation device capable of reducing administration inconsistency, pain, and disposables cost associated with needle-based injection in mass immunizations.

“Our current DNA delivery method is highly effective and already gets the job done,” said Dr. J. Joseph Kim, Inovio’s CEO. “However, to fully realize the opportunity of mass immunization against challenging infectious diseases, we believed we could create an additional advantage: that is non-invasive vaccine administration. Similar to our past acquisitions of Advisys and Inovio AS, this purchase of Bioject’s superior jet injection technology and well-positioned patents is an investment in Inovio’s future. Jet injection alone cannot achieve the utility of DNA vaccines. However, combined with our new needle-free skin-surface electroporation delivery technology, we believe we can offer a compelling solution to protect against RSV, ever-changing influenza strains, and emerging infectious diseases like Zika.”

Inovio’s leadership in advancing DNA immunotherapies delivered using needle-based injection and electroporation led to the first reported generation of robust antigen-specific immune responses correlated to efficacy in a controlled clinical study. Its Phase II data was published in September 2015 in The Lancet. This product, VGX-3100, for high-grade HPV-related cervical dysplasia, will advance into Phase III in 2016. This approach is being used in multiple current and imminent clinical studies in cancer and therapeutic applications for chronic infectious diseases such as hepatitis B and HIV.

With respect to needle-less vaccine administration, Inovio has an extensive vaccine pipeline to leverage this technique. It has ongoing clinical programs for flu, HIV, Ebola, and MERS; proof-of-principle human data has shown significant immune responses generated by its universal influenza and HIV DNA vaccines; and preclinical-stage DNA vaccines target important diseases such as Zika, dengue, Chikungunya and RSV.

Supporting the goal of non-invasive administration, the US Army Small Business Innovation Research program recently granted Inovio $500,000 to further support the development of a needle-free, non-invasive skin-surface electroporation device for DNA vaccine delivery.

Inovio will pay Bioject $4.5 million in Inovio stock (price set by 20-day weighted average share price immediately prior to closing) and $1 million in cash. The closing of this transaction is subject to approval by Bioject’s shareholders and is expected approximately 30 days from this announcement.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. It is the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, US Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.