|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