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Genocea Ditches Pneumococcus Vaccine After Phase 2 Flop, Shares Fall

Xconomy Boston — 

Genocea Biosciences may develop a successful vaccine someday, but given results the Cambridge, MA-based company revealed this morning, it will likely be for something other than pneumococcus.

Genocea’s (NASDAQ: [[GNCA]]) experimental vaccine for pneumococcus, a treatment called GEN-004, failed a mid-stage trial. Though Genocea claimed the vaccine reduced the “rate and density” of the colonization of the pneumococcus infection, the results weren’t statistically significant.

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. Genocea recently disclosed positive news from that program, and could begin a late-stage trial next year.

“At this time, we believe it is possible that future trials would require a change in some combination of dose, adjuvant or trial population to confirm any effect,” Clark said of GEN-004 in a statement.

Genocea will discuss the trial results when it releases its third quarter earnings next month. Shares plummeted about 37 percent in pre-market trading on Monday.

The trial was a placebo-controlled study in 98 healthy adults who were randomized, split into two evenly sized groups and given either three doses of GEN-004—once every four weeks—or a placebo. After dosing, patients were inoculated with a strain of pneumococcus and monitored for results—changes in the presence of pneumococcus, and how quickly it colonized—after two, seven, and 14 days. Genocea said none of the differences were statistically significant.

Genocea had billed GEN-004 as a potential “universal vaccine” for all strains of pneumococcal bacteria, which can cause deadly pneumonia and meningitis infections. The World Health Organization estimates that pneumococcus kills some 1.6 million people every year. Pfizer’s Prevnar 13, as its name suggests, protects against 13 of the most common strains and generates billions in sales every year. But there are more than 90 known pneumococcus strains, which is why Genocea and other companies—a Boston area startup called Affinivax, for instance—have been searching for a better solution.

The pneumococcus and herpes vaccines are Genocea’s only programs in clinical trials. Other candidates for chlamydia, malaria, and prevention of genital herpes (rather than treatment) aren’t in human testing as of yet.

Genocea went public in February 2014 at $12 per share. At about $4.52 early Monday, shares were worth less than half the IPO price and a fraction of its roughly $22 per share high in mid-2014. Genocea’s most significant shareholders as of an April proxy filing were FMR (14 percent), Polaris Partners (8.5 percent), Skyline Venture Partners (8.3 percent), SR One (8.2 percent) and Johnson & Johnson Development Corp. (5.9 percent). The company was formed in 2009 and spun out of Darren Higgins’s lab at Harvard Medical School.