Genocea Biosciences, Inc. (GNCA) announced encouraging results from a phase I/IIa study on its T cell-enabled immunotherapy candidate, GEN-003. The company’s shares were up 3.5% on the news.
Genocea is evaluating GEN-003 for the treatment of herpes simplex virus type 2 (HSV-2), which is the most common cause of genital herpes.
The double-blind, placebo-controlled, dose-escalation phase I/IIa study evaluated the safety and immunogenicity of GEN-003 in patients suffering from moderate-to-severe recurrent HSV-2 infection. Moreover, the phase I/IIa study was also designed to show proof-of-concept that GEN-003 can reduce HSV-2 viral shedding.
Patients were sequentially enrolled into one of three dose cohorts (10, 30 or 100 micrograms of each vaccine antigen combined with 50 micrograms of Novavax’s (NVAX) Matrix M adjuvant). Patients were administered either GEN-003, vaccine antigens without adjuvant or placebo. Results revealed that 12 months after the final dose, the mean reduction in the genital lesion rate was 42% below baseline for the 30 microgram dose group. The candidate was also found to be safe in all three cohorts.
We remind investors that in July this year, the company initiated a phase II study on GEN-003.
We are encouraged by the results from the study. According to the press release issued by Genocea, HSV-2 affects nearly 500 million people across the world including 40 million in the U.S. alone. Currently, there is no approved cure or vaccine for this disease.
We note that Genocea has another T cell-enabled candidate in its pipeline, GEN-004, for the prevention of infections caused by pneumococcus. The candidate is currently in a phase II study.
We expect investor focus to remain on pipeline updates.
Genocea currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Ampio Pharmaceuticals, Inc. (AMPE) and Lannett Company, Inc. (LCI). Both carry a Zacks Rank #1 (Strong Buy).
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