Mucus may be the butt of many a second grader’s jokes, but it actually plays a vital biological role—protecting our organs from harmful foreign particles by trapping them and shuttling them out of the body. Sometimes, though, mucus itself becomes the problem. In the lung disease cystic fibrosis, for example, super-thick mucus impedes breathing and causes infections. And the mucus in the eye is so dense that getting medications through it is nearly impossible.
Those are some of the problems Waltham, MA-based startup Kala Pharmaceuticals plans to tackle with the funding it announced last week. Kala, which has been in stealth mode since it was founded in early 2010, raised $6.2 million in equity financing from Lux Capital, Polaris Venture Partners, Third Rock Ventures, and Lighthouse Capital Partners. That brought the total seed funding raised by the startup to $11.2 million. The company was co-founded by MIT professor and prolific entrepreneur, Robert Langer (also one of our Xconomists).
The technology behind Kala originated in the lab of Justin Hanes, a former graduate student in Langer’s lab who went on to Johns Hopkins, where he is now a professor and director of the medical school’s Center for Nanomedicine. Several years ago, Hanes and a colleague started studying the mechanisms by which viruses are able to break through mucus barriers. They focused on the surfaces of the viral particles, discovering specific characteristics that cause viruses to interact differently with mucus than other foreign invaders do.
Kala took that know-how and used it to develop particles with specialized coatings that allow them to bust through mucus, says Colin Gardner, a veteran of Merck and Johnson & Johnson who is serving as an advisor to Kala. “We can modify the surface of the particles so that they penetrate the mucus and then stay there and release the drug over an extended period of time,” Gardner says.
Langer says that even though the technology didn’t emerge directly from his lab, he was sure enough of its potential therapeutic value that he co-founded the company and took a board seat. “This is a totally untapped area—nobody has figured this out before,” Langer says. “If you can get through the mucus barrier, you can hit some important targets.”
One of Kala’s priorities is to try to develop medications that can penetrate the thick mucus that forms in cystic fibrosis patients. Kevin Pojasek, Kala’s vice president for corporate development, says the startup’s scientists actually tested their particles in mucus samples from patients. “When you compare that mucus to normal, healthy mucus it’s almost like rubber,” says Pojasek, who has worked at several biotech startups, including Satori Pharmaceuticals and Solace Pharmaceuticals. Kala’s experiments, he adds, “gave us confidence that we can use our technology to address this challenging clinical problem.”
Kala received a grant from the National Heart, Lung, and Blood Institute, a unit of the National Institutes of Health (NIH), to develop an inhaled treatmentfor cystic-fibrosis related infections. The amount of the award wasn’t disclosed, and Pojasek says Kala is not yet ready to discuss details about the project. He says the company plans to talk publicly about its pipeline later this year.
A separate division of the NIH, the National Eye Institute, is supporting Kala on a project aimed at improving eye drops. The company has not yet identified the best use for its technology in eye diseases, but the opportunities are vast, Gardner says. “Think about the eye drop,” he says. “It drips onto your lid or into your nose and vanishes from the surface of the eye in about 20 seconds. If there’s a way to incorporate the drug into something that can reside in the eye for a longer period of time, then you can treat any number of ophthalmic diseases.”
Kala’s technology could be applied to already marketed drugs in addition to new molecules under development, and Kala is open to partnering with pharmaceutical companies that want to use it to advance their own projects, Pojasek says. He says that Kala’s financing will be enough to get it through the first quarter of 2013, by which time he hopes the company will have secured some partnerships.
Gardner says one of Kala’s biggest challenges will be persuading potential pharma partners that the particles can be manufactured in a scalable, cost-effective way. A bit of fortuitous timing allowed the startup to snag some valuable expertise in that arena. In 2009, Gardner retired from TransForm Pharmaceuticals, a formulation company based in the Boston area that was owned by J&J. Shortly thereafter, J&J closed the site and offered all its employees jobs in New Jersey. “A lot of them didn’t want to go there. So we hand picked four people from TransForm, who are helping us think about how scale up an industrial process that will be efficient,” Gardner says.
Dozens of companies are working on drug-delivery systems based on nanoparticles, including two Langer-connected, Boston-area startups, BIND Biosciences and Selecta Biosciences. But those companies aren’t focusing on penetrating mucus. Most efforts that are aimed at breaking through the mucosal barrier take an “adhesive approach,” Pojasek says. In other words, they’re designing particles to stick to the mucus rather than penetrate it. “In most circumstances, if something sticks it’s going to lead to rapid clearance, and you’re not going to access the underlying tissue,” Pojasek says. “We’ve taken the contrarian view. We believe penetrating the barrier will give us better access to the underlying disease.”
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