Inovio Pharmaceuticals (INO -0.90%) was first formed way back in 1983. After 33 years and several name changes, the company still doesn't have a product on the market. Inovio does have several pipeline candidates that could eventually become winners. Here's why the biotech's best chance for success might come from a DNA vaccine that's still in early-stage testing: INO-3112.
Hype and head start
Granted, INO-3112 might seem like a dark horse in Inovio's race for a commercial victory. Experimental Zika virus vaccine GLS-5700 has received a lot more publicity in 2016. Inovio trumpeted every advance for GLS-5700 throughout the year, from positive results in mice and monkeys to the first-ever testing of a potential Zika vaccine in humans.
However, there are many hurdles to jump before GLS-5700 has a shot at winning regulatory approval. And Zika might not be that big of a deal by the time the approval is secured. The World Health Organization (WHO) recently declared that the Zika virus is no longer a global health emergency. That could change down the road, but there's also a possibility that people develop natural immunity to the virus over time.
Neither GLS-5700 nor INO-3112 are Inovio's lead product, though. Experimental vaccine VGX-3100, which targets treatment of precancerous cervical disease caused by human papillomavirus (HPV), has a head start on all the rest of the biotech's pipeline. Inovio had announced plans to begin late-stage testing of VGX-3100 in 2016, but those plans were put aside when the U.S. Food and Drug Administration (FDA) placed a clinical hold on the proposed study.
The FDA requested additional information about the shelf life of parts of Inovio's Cellectra 5PSP immunotherapy delivery device. Inovio says that it's cooperating fully with the FDA and still thinks the late-stage study could move forward in the first half of 2017.
I don't think this will be a showstopper for VGX-3100. However, I also don't think that the vaccine will necessarily be the big story for Inovio.
It seems quite possible that any success for VGX-3100 merely serves as a prelude for the entrance of INO-3112. Why? INO-3112 basically is VGX-3100 with DNA-based immune activator encoded for IL-12, an interleukin that plays a key role in multiple diseases, thrown into the mix.
INO-3112 is the only candidate in Inovio's pipeline to attract the attention and money from Big Pharma. AstraZeneca (AZN 1.04%) ponied up $27.5 million up front in 2015 to acquire exclusive rights to the immunotherapy. Inovio stands to gain up to $700 million in development and commercial milestones plus double-digit percentage tiered royalties on any future sales of INO-3112. AstraZeneca is also picking up the tab for development costs.
Inovio recently presented interim data results from a phase 1/2a study of INO-3112 in treating head and neck cancer associated with HPV. These results showed that antigen-specific CD8+ killer T cell responses were generated in four out of five patients who were administered INO-3112. Those four patients remained free of disease after nine to 24 months of follow-up.
INO-3112 is also in a phase 1/2 study for treatment of cervical cancer. Final data collection for the primary outcome of this study is expected to complete by Sept. 2017 with the full study wrapping up by March 2018.
Opportunity and risks
Nearly 13,000 new cases of cervical cancer are diagnosed each year in the U.S. Around 15,700 cases of HPV-associated oropharyngeal cancer are diagnosed in Americans each year. The opportunity for INO-3112 is significant.
However, there's still a long way to go until INO-3112 could win approval. The immunotherapy might never make it to market. Early results for INO-3112 are promising, but the biotech landscape is littered with once-promising candidates that flopped in later-stage studies.
I think INO-3112 could still give Inovio its best chance to get where it wants to be. The company has waited 33 years. Expect another few years of waiting.