Roche and Inovio Pharmaceuticals, Inc. have entered into an exclusive worldwide license agreement to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B. The licensed compounds are currently in preclinical development and have generated robust T-cell responses in animal models.

Roche acquired an exclusive license for Inovio's DNA-based vaccines INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the use of Inovio's Cellectra electroporation technology for delivery of the vaccines. Roche also obtained an option to license additional vaccine opportunities in connection with a collaborative research programme in oncology. Roche and Inovio will collaborate to further develop INO-5150 and INO-1800.

Under the terms of the agreement, Roche will make an upfront payment of US$ 10 million to Inovio. Roche will also provide preclinical R&D support and payments for near-term regulatory milestones as well as payments upon reaching certain development and commercial milestones potentially up to US$ 412.5 million. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-5150 or INO-1800. In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.

Commenting on the deal, Hy Levitsky, head of Cancer Immunology Experimental Medicine at Roche, said, "At Roche we are always interested in finding first-in-class and best-in-class therapies that may become the next generation treatments for patients with different types of cancer. INO-5150 will allow promising combination opportunities with the Roche portfolio, particularly with our emerging cancer immunotherapy molecules."

Janet Hammond, head of Infectious Diseases Discovery & Translational Area at Roche, added, "We are very excited to have this potentially very important and novel mechanism of action as part of our portfolio as we seek to address the significant unmet medical need in chronic hepatitis B infection."

"This partnership represents an important milestone in Inovio's growth and maturing product portfolio. Roche brings to our immunotherapy candidates its leadership position and track record for developing and marketing innovative first-in-class therapies," said Dr J Joseph Kim, Inovio's president and CEO. "Collaborating with the world's preeminent oncology development partner allows us to rapidly advance two of our promising near-clinical stage immunotherapy products from our product pipeline as we continue development of our phase II lead product, VGX-3100, for treatment of HPV-related cancers and dysplasia."

Inovio's dual-antigen synthetic DNA vaccine (INO-5150) targets prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). A study in monkeys showed that vaccination with INO-5150 generated strong and robust T-cell immune responses that were the highest generated by a PSA-based immunotherapy in animal studies and were similar to the immune responses generated by VGX-3100, Inovio's phase II-stage therapeutic HPV vaccine that generated best-in-class T-cell responses in a phase I study.

Inovio's SynCon DNA vaccine for prostate cancer was designed with PSA and PSMA synthetic consensus immunogens based on human and macaque sequences, resulting in amino acid sequences that differ slightly from the native human protein. In humans, this novel approach is utilized to help the body's immune system recognize cancerous cells created in the body as 'foreign', overcoming the body's self-tolerance of these cells and mounting an immune response to clear them.

Inovio has reported preclinical data showing its hepatitis B vaccine (INO-1800) generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice. These results indicate this DNA vaccine's potential to treat hepatitis B infection and prevent further development of the infection into liver cancer in humans.

In a preclinical study, researchers found the vaccine-specific T-cells exhibited a killing function, and could migrate to and stay in the liver and cause clearance of target cells without evidence of liver injury. This was the first study to provide evidence that intramuscular immunization can induce killer T-cells that can migrate to the liver and eliminate target cells.

To provide worldwide rights to Roche, Inovio has re-acquired its hepatitis B, Asian-country rights from Inovio's international affiliate.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate.

Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience.