|Genocea CEO Chip Clark|
Genocea Biosciences' ($GNCA) in-development vaccine for genital herpes met its goals in a Phase II trial, sending the biotech's shares soaring.
The protein treatment, GEN-003, works by galvanizing the body's T and B cells to attack herpes, and, in a 310-patient trial, the vaccine significantly beat out placebo in tamping down viral activity.
The trial put herpes-infected patients into 7 groups, administering 6 dosage levels of GEN-003 and administering placebo to the final group. All but the weakest dose of GEN-003 demonstrated a statistically significant improvement in viral shedding rate, a key measure of herpes' vitality. And each patient group, including those taking placebo, charted a statistically significant improvement in self-reported genital lesions compared to baseline, Genocea said.
On the safety side, the trial found no serious adverse events associated with GEN-003, the company said, and there was no difference in the rate of patient dropouts across the 6 dose groups.
The news sent Genocea's shares up about 27% on Tuesday morning, fueled by investor confidence that the biotech can get its vaccine into Phase III and keep up the momentum.
There remains no cure for genital herpes, but viral shedding is the major driver of the virus' transmission. And GEN-003, if it can continue to come through in the clinic, could present a viable way to reduce the spread of herpes, Genocea believes.
"We are extremely pleased with these positive top-line results which have successfully allowed us to identify the optimal dose to advance into further trials," CEO Chip Clark said in a statement. "The results strengthen the product profile from our Phase I/IIa trial, which we have shown in market research to be highly clinically meaningful and commercially attractive, providing further evidence of the strong value proposition of GEN-003 for patients, physicians and payers."
Beyond GEN-003, Genocea is at work on the Phase II GEN-004, a vaccine for pneumococcal infections, and a slew of preclinical candidates for chlamydia, malaria and cancer.
- read the announcement