Microcap Cerulean Pharma ($CERU) announced it will cut 48% of its workforce as it reels from this week’s failed Phase II combo study with its lead candidate CRLX101.
The drug, a nanoparticle-drug conjugate, was being tested alongside Roche’s ($RHHBY) aging angiogenesis inhibitor Avastin (bevacizumab) in patients with advanced renal cell carcinoma (RCC), a form of kidney cancer.
The cocktail treatment was being tested against a standard-of-care (SOC) option, which included a host of marketed cancer meds--but it posted midstage results this week showing no statistically significant difference in median progression-free survival and objective response rate for the CRLX101 combo compared with SOC.
Cue the inevitable “reduction in workforce” release that will see its staffers cut down to just 23 full-time equivalent employees, with those being axed set to be gone by the end of the year.
“This reduction in force is a difficult but necessary step as we refocus our development priorities for CRLX101, our lead NDC candidate,” said Christopher Guiffre, president and CEO of Cerulean.
“I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Cerulean and CRLX101. We remain committed to unlocking the power of this potential best-in-class topoisomerase 1 inhibitor, as well as realizing the promise of our pipeline and platform.”
The Waltham, MA-based biotech said it hopes to save about $5 million a year through the cuts. It did not however provide details on which areas it would be taking the ax to.
To date, CRLX101 has been granted by the FDA: orphan drug designation for the treatment of ovarian cancer; fast track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma; fallopian tube or primary peritoneal cancer; and fast track designation in combination with Avastin in metastatic RCC.
Cerulean’s shares were down 56% yesterday on the news as it nears penny-stock territory, although in after-hours trading it nudged up slightly by just under 1%. Its market cap is now just $31.5 million.
This is not, however, the first time it has flubbed a major test, as three years’ ago, CRLX101 missed an ambitious main endpoint of overall survival in patients with non-small cell lung cancer in a Phase IIb study. It touted its tie-up with Avastin as key to moving on from this failure, meaning this week’s news will only be a huge setback for the small biotech.
It’s been a tough year for nanoparticle cancer drug developers, and Cerulean’s unsuccessful test comes just a few months after fellow Massachusetts nanoparticle biotech Bind Therapeutics--which was seen as the leader in a wave of next-generation nanotechnology companies--filed for bankruptcy and recently sold off its assets to Pfizer ($PFE) for just $40 million.
The big idea driving this field is to ferry cancer drugs directly to tumors, reducing contact with healthy tissue and therefore reducing the risk of side effects. But the clinical results from Bind and Cerulean have simply not delivered on the early promise of this new method, leaving an open question about the future of nanoparticle research in cancer.
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