Genocea shares shoot up on promising genital herpes data

Genocea CEO Chip Clark

Shares of Cambridge, MA-based Genocea Biosciences ($GNCA) shot up about 25% this morning after the biotech reported positive 12-month Phase II data on its lead therapy for genital herpes.

GEN-003 had a distinct impact on viral activity as well as disease activity, the biotech reports, with significant reductions from baseline in viral shedding as well as a reduction in lesion rates. And the results fit in with its upbeat assessment of the 6-month study results.

Genocea says that it will release more scientific data at an upcoming conference, but it sounded a strong note of confidence in looming Phase IIb results as it sets up a confirmatory study design for Phase III. The treatment is designed to spur a T cell as well as a B cell antibody immune response to HSV-2.

"What several big vaccine companies failed to do, we have now done in spades," Tweeted Genocea CEO Chip Clark. "Great day for patients and Genoceans."

Genocea was hit with a serious setback last fall, when GEN-004, its vaccine for pneumococcal infection, flopped in a midstage study. That failure prompted the company to shift its attention to GEN-003. Two other programs are listed on its website as preclinical efforts. 

Clark elaborated on his plans in a statement.

"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," said Clark. "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."

- here's the release

Suggested Articles

Gilead Sciences is paying Nurix $45 million upfront in a deal that could reach $2.3 billion in value if all milestones are met and royalties realized.

In mice, Kymera's lead drug promoted tumor regression, both on its own and in combination with BTK inhibitor Imbruvica.

The report features testimony that some NHS bodies are “actively instructed not to deal with industry by their local leadership.”