martedì 24 dicembre 2013

Genocea brings 2nd vaccine to clinic to rival $4B-a-year Prevnar

Genocea Biosciences, which three months ago announced what it called “unprecedented” results in a trial of its herpes vaccine, today began an early-stage trial of a second potential vaccine based on the same disease-fighting method.
The Cambridge biotech has been focused on fighting infectious diseases through stimulation of T cells in the body since it was founded in 2007. CEO Chip Clark says the approach is superior to existing vaccines (which are based on the so-called B-cell response) in two ways: It can potentially fight all strains of a disease, rather than a select few, and can kill infected cells even before they make their way into the bloodstream and potentially start to make a patient sick.
That approach has resulted in a potential vaccine for herpes simplex virus type 2, and the results from its first-ever human trial were announced in September. The study found that the vaccine reduced viral-shedding, which often results in the disease emerging in lesions.
It has also been behind $73 million in investment to date from backers including Polaris Venture Partners, Lux Capital Management, Johnson & Johnson Development Corp., Skyline Ventures, Cycad Group, Auriga Partners, the Bill & Melinda Gates Foundation, MP Healthcare Ventures, and Morningside.
Today, it’s led to the trial of a potential vaccine against pneumococcus, a disease of the nose and throat which can lead to pneumonia, meningitis and sepsis, and kills between 500,000 and 1 million children every year. The company has begin a a Phase 1 clinical study with GEN-004, which Clark intends to be the first vaccine that would protect against all 90 strains of the disease.
Clark said that the current market-leading vaccine on the market is Prevnar, a $4 billion-a-year drug marketed by Pfizer. (One of the members of Genocea's board, George Sibor, is the former chief scientific officer of Wyeth Vaccines where he lead the development of Prevnar) Clark says the vaccine is “phenomenal” in its effectiveness against 13 of the most important strains of the disease, but says “there is evidence that the 80-plus strains that are not covered by the vaccine are increasing.”
The Phase 1 study will involve about 90 healthy adult volunteers, and will test the safety and effectiveness of GEN-004 in a range of doses. The company expects results in the second quarter of 2014.

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