|Oliver Fetzer, CEO of Cerulean Pharma|
Cerulean Pharma will come to a crossroads in 2013. Its lead drug program is slated to deliver Phase IIb data in the early part of the year, offering a clear readout on its potential against lung cancer with overall survival (OS) data. There are two more studies in the pipeline, with more on the drawing board. Partnership discussions are under way, with a plan to start talking deal terms once the JP Morgan confab rolls around. And now the Cambridge, MA-based biotech's CEO tells FierceBiotech that the company has topped up its accounts with $13 million in fresh venture cash from its consortium of A-list backers.
The new injection of venture cash--an extension of its Series D announced late last year--brings Cerulean's total raise to more than $80 million, says CEO Oliver Fetzer. That money has financed a series of studies of CRLX101, a treatment that ties nano-sized particles of a particularly toxic therapy to a polymer, creating a structure designed to thread its way through the unique tissue found in the leaky vasculature (blood vessels) of a tumor in a carefully targeted attack on cancer.
A midstage study for ovarian cancer is also under way, along with another study for renal cell carcinoma in a combo with Avastin. But it's the Phase IIb non-small-cell lung cancer study with 150 patients that will offer the most advanced illustration of its potential, with investigators tracking survival rates as opposed to a softer progression-free survival target. Solid OS data in Phase IIb could lay the foundation for a larger, confirmatory Phase III study that would look quite attractive to potential partners.
"The great news is we are running late," Fetzer tells FierceBiotech. "The patients are living longer."
Now, of course, the data have to demonstrate that the drug is working as planned. If it does, all of Cerulean's technology will look more appealing to a broad number of possible partners. Conjugating a polymer with explosively toxic particles targeted at tumors could work in a number of cancers. And there's also a variety of possible combination programs that can be set up.
However it all sorts out, says Fetzer, Cerulean--a 2011 Fierce 15 company--plans to hang on to some rights to the drug, with an eye to jump into commercialization at some point. CVF, an affiliate of Henry Crown and Company, jumped in the latest venture raise along with Polaris Venture Partners, Venrock Associates, Lilly Ventures, Lux Capital and Bessemer Venture Partners.