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Trial Shows Herpes Simplex Therapy Generates Immune Response

Herpes simplex viruses

Herpes simplex viruses (Centers for Disease Control and Prevention)

21 July 2014. An intermediate stage clinical trial of an immunotherapy by Genocea Biosciences to fight herpes simplex virus 2 — the main cause of genital herpes — shows the treatment generates an immune system response to the disease that lasts an entire year. The findings were presented this week by Genocea vice-president Jessica Baker Flechtner at this year’s International Herpesvirus Workshop in Kobe, Japan.

Herpes simplex virus 2, or HSV-2, affects the skin and mucous membranes of the genitals and is transmitted through sexual contact. The disease can spread even if the partners have no open sores or symptoms. Genital infections from the virus affect more women than men.

Genocea Biosciences is a biotechnology company in Cambridge, Massachusetts developing vaccines and immunotherapies to protect against or treat symptoms of virus and bacteria pathogens including those causing pneumonia, cancer, and malaria, as well as genital herpes. Its vaccines and immunotherapies aim to harness the power of T cells, white blood cells that directly or indirectly attack specific invading pathogens.

The company’s technology platform, called Atlas, is based on research by immunologist Darren Higgins at University of California in Berkeley and Harvard Medical School. The technology starts with high-throughput screening to identify a small number of key targets, then developing antigens corresponding to those targets to stimulate the appropriate T cells for preventing or treating the infection.

Genocea’s lead candidate is an immunotherapy for HSV-2, code-named Gen-003, designed to reduce the duration and severity of symptoms associated with the disease. The treatments aim to generate immune system responses from T-cells and other antibodies, and can be given with or without an adjuvant or booster.

The clinical trial tested Gen-003 at various doses — 10, 30, and 100 micrograms — both with and without an adjuvant, against a placebo, all administered in three injections at 21-day intervals. The study enrolled 143 patients with HSV-2 at 7 sites in the U.S., and aimed primarily to highlight any safety or tolerability issues over a period of 57 weeks. But the trial also measured T-cell and antibody responses to the antigens in the therapy, as well as changes in genital lesions and the proportion of days with viral shedding, where the virus is detected on the skin.

The results presented at the workshop in Japan show Gen-003 generates a response from the immune system, producing more T-cells, as well as immunoglobulin-G antibodies that fight bacterial and viral infections, and neutralizing antibodies. Moreover, this elevated immune response continued 12 months after the last injection.

Topline results from the trial, released earlier in July, show patients taking Gen-003 in 30 microgram doses reduced their genital lesion and viral shedding rates by 65 and 40 percent respectively, compared to baseline measures, after 6 months. In addition, the genital lesion rate continued 42 percent below the baseline after one year. The results show as well that the treatments are safe and well tolerated.

Genocea is planning a larger clinical trial to test Gen-003 at 30 and 60 microgram doses, with various levels of adjuvants, against a placebo, and with a larger number of HSV-2 patients.

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