Vical Incorporated Clinical Setback; 2 Analysts With Different Views

T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Net Loss: Net loss was $10.3 million for the quarter ended December 31, 2015, compared to a net loss of $11.7 million for the same period in 2014. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements. To identify in vivo EC50 and m, we repeatedly simulated trials with 30 patients per arm who swabbed for 30 days each at all 4 doses. Genocea Biosciences’ stock was sold by a variety of institutional investors in the last quarter, including Franklin Resources Inc.. The objective of the collaboration is to use ATLAS to further Genocea’s expertise in identifying signatures of T cell responses in cancer patients and to discover new T cell cancer vaccine antigens. In 2012 AiCuris signed a license agreement with Merck & Co (MSD), which attracted significant attention being one of the largest agreements of this kind in the European biotech industry.

The company is developing drugs for the treatment of viruses such as human cytomegalovirus (HCMV), herpes simplex virus (HSV), hepatitis B virus (HBV), and adenoviruses. Pritelivir (topical), designed for the treatment of recurrent labial herpes (mainly HSV-1), has just started a clinical phase 2 trial after reporting successful phase 1 clinical results. Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. As a compound derived from a novel chemical class (thiazolylamides), pritelivir is active against both types of herpes simplex virus (HSV-1 and HSV-2) causing labial and genital herpes, respectively, and retains activity against viruses which have become resistant to marketed drugs. In immunocompromised patients, HSV can lead to serious complications. The negative stigma associated with genital herpes and visible facial lesions may cause psychological distress. Call me.

The peer-reviewed JAMA article reports the results of a second clinical phase 2 study to compare the efficacy of pritelivir with valacyclovir for suppression of HSV-2 infections. More than 400 million people worldwide have genital herpes, according to Genocea. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, will host a virtual Research and Development (R&D) Day for analysts, investors and media on Wednesday, December 14, 2016, starting at 8:30 a.m. “These publications show, once again, that pritelivir is proving to be an exceptional approach to herpes treatment. Targeting different potential vulnerabilities of the virus with a new class of compounds provides the opportunity to significantly increase efficacy. There is no FDA approved vaccine for HSV-2. Currently the Company runs two clinical development programs with pritelivir.

Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). The first indication is the oral treatment of seriously ill patients suffering from genital herpes who do not respond to established herpes drugs, and the second – in an entirely different area – the treatment of labial herpes using a cream. Genocea plans to release more data at an upcoming conference, the company said in a statement. This data could have important implications for the understanding of how the immune system controls genital herpes infections given that polyfunctional T cells have been linked to the control of HIV and other persistent viral infections. Genital herpes is a recurrent, lifelong viral infection and while symptoms can be managed with antiviral drugs, patients tend to suffer recurrent outbreaks, in some cases several times a year. Secondary endpoints included clinical outcomes such as days with genital lesions and frequency of pain. (2016) April 7, 2016.

The treatment is designed to spur a T cell as well as a B cell antibody immune response to HSV-2. Patient screening for the trial, which was initiated in December 2015, is complete. Genocea CEO Chip Clark (pictured above) said today that the company will suspend development of GEN-004 and put all of its resources behind GEN-003, a herpes vaccine in mid-stage testing. However – some individuals that are HSV2 positive don’t shed the virus, which means that something’s happening in their bodies to control the pathogen. (GNCA), a company developing T cell-directed vaccines and immunotherapies today held its first R&D day for investors and analysts. That reduction, Clark said, in conjunction with GEN-003’s durable efficacy and convenience, could position the jab to serve as a “cornerstone” for genital herpes treatment. And it’s in an even better position than Agenus’ ($AGEN) HerpV, according to a GlobalData analyst.

17, 2013 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today announced the initiation of its Phase 1/2 trial of the company’s Vaxfectin™-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), a cause of genital herpes, in approximately 156 subjects.