Inovio Pharmaceuticals, Inc. (NASDAQ:INO) has revealed on Wednesday that it will continue to independently develop INO-1800, a hepatitis B DNA immunotherapy, after Roche Holding Ltd. (OTCMKTS:RHHBY) decided to entirely discontinue collaborating with the company.
Inovio’s Plans for INO-1800 Development
The company will proceed with the randomized, open-label, active-controlled Phase I clinical trial of INO-1800 in 30 clinical sites in the US and Asia-Pacific, with enrollment expected to be completed by the first half of 2017. The study aims to evaluate the immunogenicity, safety, and tolerability of INO-1800 and its combination with INO-9112, an IL-12-based immune activator in adults with chronic hepatitis B infection. Meanwhile, secondary endpoints include the cellular and humoral immune response to INO-1800 and the effects on different antiviral and viral parameters.
Dr. Joseph Kim, Inovio Pharmaceuticals CEO and President, expressed in behalf of the company that he is confident about the potentials of INO-1800. Interim results of the clinical trial, specifically, have demonstrated the potential of the immunotherapy to treat chronic hepatitis B infection.
All licenses granted to Roche back in 2013 relating to INO-1800 will be returned to Inovio Pharmaceuticals.
Chronic Hepatitis B
Chronic hepatitis B infection is currently one of the primary causes of liver cancer and liver cirrhosis, affecting more than 240 million individuals globally. Over 60 million of these individuals are at risk for serious liver cancer and liver cirrhosis complications.
Phase I Clinical Trial of GLS-5700
Last week, Inovio Pharmaceuticals has announced the dosing of the first participant in the Phase I clinical trial evaluating GLS-5700 for the treatment pf Zika DNA virus. Currently, the open-label Phase I clinical trial is already approved by the US Food and Drug Administration (FDA) and Health Canada— Health Products and Food Branch.
The study involves 40 healthy adult participants. It has a primary endpoint of determining the immunogenicity, safety, and tolerability of GLS-5700 administered with CELLECTRA-3P, a proprietary intradermal DNA delivery platform.
According to the US Centers for Disease Control (CDC), about 30 million to 40 million individuals from the US travel to areas affected by the Zika virus every year. As a result, there is a growing need for a Zika vaccine to counter the harmful effects to public health.
