Inovio going it alone after Roche departure
- Inovio Pharmaceuticals announced Wednesday that Roche is returning all rights for its early-stage hepatitis B vaccine back to the company.
- The biotech will continue development of the compound on its own and expects to complete enrollment of a Phase I study in the first half of 2017.
- Inovio stocked dipped about 8% in early morning trading as investors worried about the viability of the program going forward.
It’s never a good sign when a big pharma company hands the rights to a drug back to its biotech partner. The exit usually indicates the compound isn’t effective or doesn’t have commercial viability.
In the case of Inovio and Roche, this is the second program in as many years that the European pharma has dropped. Roche will return all rights to INO-1800, a DNA immunotherapy in development for hepatitis B.
The biotech put on a brave face and intends to continue development of the drug on its own—promising to complete enrollment of a Phase I trial by the first half of 2017, with results expected later in the year. The company intends to enroll patients at 30 sites across the U.S. and the Asia-Pacific region. The study will test for safety and tolerability.
"Inovio was already managing the phase 1 clinical trial so the study will continue on track without disruption," said Inovio President and CEO Joseph Kim in a statement.
The pair originally linked up in 2013, when Roche signed on to be a development partner for the hepatitis B drug and a prostate cancer vaccine that were both preclinical at the time.
Roche paid Inovio $10 million and agreed to more than $600 million in potential milestones related to development and commercialization of the two programs.
But Roche subsequently bailed on the prostate cancer vaccine, INO-5150, in November 2014. Like INO-1800, Inovio said at the time it would move the compound through Phase I on its own. The drug has not progressed past that point since.
Roche paid a $3 million milestone to Inovio in late-2015 when Phase I was initiated for INO-1800.
Inovio is best known in the industry for its vaccine candidates in rare infectious diseases like Ebola and the Zika virus. Unfortunately, those programs are all still in Phase I and not likely to make it to market while those outbreaks are still immediate health threats—diminishing their commercial viability.
Meanwhile, Inovio is going to have a tough time in hepatitis B. Unlike it’s similarly-named counterpart hepatitis C, hepatitis B affects fewer patients and a "cure" will likely be harder to develop. And most of the major companies in the hep C space are also developing hep B candidates, making the field a crowded one.
- Inovio Pharmaceuticals Statement
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