Inovio Pharmaceuticals (NYSE AMEX: INO) has teamed up with affiliate VGX International to finance clinical development of the Blue Bell, Pennsylvania-based drug developer’s therapeutic vaccines for hepatitis B and C infections.
Under the terms of the deal, VGX will receive marketing rights for the vaccines in Asia, but Inovio will hold onto the lucrative Japanese market. In return, VGX has agreed to fully fund IND-enabling and initial phase I and II clinical studies.
About 470 million people are infected with Hepatitis B and C worldwide.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Inovio will receive payments based on reaching clinical milestones and royalties based on sales in the licensed territories and retains all commercial rights in all other territories.
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. IND-enabling toxicology tests will be conducted in the first half of 2012, with the intent to initiate a phase I clinical study late next year. The target population for the vaccine clinical trials will be individuals infected with HCV.
Dr. J. Joseph Kim, Inovio president and CEO, said the initiative is “an integral part” of a multipronged approach to develop its therapeutic hepatitis vaccine pipeline.
The study was funded in part by a $2.8 million PA CURE grant received by Inovio and its collaborators in 2010 to develop this multi-antigen synthetic HCV vaccine.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Inovio merged with VGX in 2009, putting the company on a firmer financial footing and positioning it to expand its DNA vaccine program for cancer and infectious diseases. In September of last year it received a $3.1 million grant from the National Institutes of Health with the University of Pennsylvania to fund the development of its DNA vaccine for influenza.
