Genocea Breaks Out With Very Positive Mid-Stage Results

By Chris Lange Updated Jan 13, 11:19AM EST · Published Mar 31, 10:10AM EDT

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Genocea Breaks Out With Very Positive Mid-Stage Results — © Thinkstock

Genocea Biosciences Inc. (NASDAQ: GNCA) soared early on Thursday, following the release of positive data from its mid-stage genital herpes clinical trial. The company announced positive 12-month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

The company believes that these results highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape. Also considering the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks.

GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease.

Ultimately the treatment was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.
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Chip Clark, president and CEO of Genocea, commented:

We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals – but with greatly improved convenience. We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017.

Shares of Genocea traded up over 28% at $5.08 early Thursday, with a consensus analyst price target of $13.00 and a 52-week trading range of $2.56 to $16.18.

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.