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Immunotherapy Biotech Raising $45 Million in IPO

Herpes simplex viruses

Herpes simplex viruses (Centers for Disease Control and Prevention)

12 March 2015. Genocea Biosciences Inc., a biotechnology company developing immunotherapies to treat genital herpes and other diseases, is raising $45 million in its initial public offering of stock. The Cambridge, Massachusetts enterprise is issuing 5,454,545 shares priced at $8.25. The company trades on the NASDAQ exchange under the symbol GNCA. As of 12:00 pm ET, shares are trading at $8.97.

Genocea develops 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 company’s processes begin with high-throughput screening to identify a small number of key targets, then develop 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 Herpes simplex virus 2, or HSV-2, code-named Gen-003, designed to reduce the duration and severity of symptoms associated with the disease. Gen-003 aims to generate immune system responses from T-cells and other antibodies, and can be given with or without an adjuvant or booster.

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.

A 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 in July 2014 at a 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 that month, 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.

In January, Genocea said it began enrolling some 300 patients in an intermediate-stage clinical trial to test Gen-003 at 30 and 60 microgram doses, with various levels of adjuvants, against a placebo.

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