Inovio inks licensing deal for hep B and C vaccines in Asia with VGX International

Inovio Pharmaceuticals (AMEX:INO) said Monday it has entered into a product development agreement with affiliate VGX International, to co-develop Inovio's SynCon therapeutic vaccines for hepatitis B and C infections.

Under the terms of the deal, VGX will receive marketing rights for these vaccines in Asia, excluding Japan, and in return, will fully fund initial phase one and two clinical studies.

Inovio will also receive payments based on certain clinical milestones, as well as royalties based on sales in the licensed territories. The company will also retain all commercial rights in all other territories not included under the agreement.

The first product to enter clinical testing will be a synthetic multi-antigen hepatitis C virus (HCV) vaccine, covering genotypes 1a and 1b and targeting the antigens NS3/4A, as well as NS4B and NS5A proteins. The vaccine will be delivered with Inovio’s CELLECTRA delivery device.

IND-enabling toxicology tests will be conducted in the first half of 2012, Inovio said, with the intent to initiate a phase one clinical study later in the year. The target population for the vaccine clinical trials will be HCV-infected individuals.

The vaccine targeting NS3/4A was tested in preclinical trials, with positive results published in the journal Molecular Therapy. Following immunization, animals showed strong HCV-specific T cell immune responses, "strikingly" similar to those reported in patients who have cleared the virus on their own, the company said.

The animal study was funded in part by a $2.8 million grant received by Inovio and its collaborators in 2010 to develop this multi-antigen synthetic HCV vaccine.

"Hepatitis B and C are a major global health problem, with about 470 million people infected worldwide. As a development leader of synthetic vaccines, we are pleased to collaborate with our affiliate VGX International to advance our global, multi-antigen HCV vaccine into the clinic," said Inovio's president and CEO, Dr. J. Joseph Kim. 

"This latest development is an integral part of Inovio’s multi-pronged approach to develop our therapeutic hepatitis vaccine pipeline."

Inovio also has an ongoing open-label phase two clinical study with ChronTech Pharma AB, to test the effect of a DNA vaccine encoding for NS3/4A protein administered by Inovio's MedPulser electroporation delivery device followed by the standard of care drug treatment. In an earlier phase one study, five of six participants (83%) who received the vaccine along with the standard of care treatment cleared the virus.  Interim results from the phase two study are expected in 2012.

Under the agreement reported today, Inovio and VGX International will also co-develop Inovio’s SynCon therapeutic vaccine for hepatitis B virus (HBV).

HBV and HCV infections are major causes of chronic liver disease, with three to five times more people living with chronic viral hepatitis infections than with HIV infection. In the next 10 years alone, about 150,000 people in the United States are expected to die from liver cancer and end-stage liver disease associated with chronic hepatitis B virus and hepatitis C.

The direct medical costs associated with HBV and HCV infections in the U.S. are estimated to reach nearly $8 billion annually.

Inovio's SynCon vaccines are designed to provide cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. The company's clinical programs include phase two studies for cervical dysplasia/cancer, leukemia and hepatitis C virus and phase one studies for influenza and HIV.