|Cerulean CEO Christopher D. T. Guiffre|
AstraZeneca ($AZN) is teaming up with Cambridge, MA-based Cerulean, launching a combo study that marries the biotech's nano-polymer drug conjugate with the pharma giant's Lynparza (the PARP inhibitor olaparib) to test its synergistic effects on tumors. And the National Cancer Institute is stepping in to fund the study and carry it out.
The companies note that this is the first in a series of planned combination drug studies, a popular field in oncology as drugmakers mix and match therapies to see how experimental drugs can amp up the effects of approved therapeutics. In this case, AstraZeneca is tying up with a biotech ($CERU) that had to regroup following a catastrophic setback for their lead drug two-and-a-half years ago.
Cerulean's CRLX101 uses a nano delivery vehicle to dispatch small doses of the highly toxic camptothecin directly to targeted cancer cells. But in a Phase IIb drug study back in 2013, the drug flopped badly. The biotech wrote it off to the site selections in Russia and the Ukraine, though its shares tabled badly on the news. Since then, founding CEO Oliver Fetzer jumped ship and the company is now run by former business chief Christopher D. T. Guiffre, who was promoted to the helm.
Cerulean has never fully recovered from its clinical-stage disaster. The company--which raised more than $80 million in venture cash--went public in the spring of 2014, selling discounted shares at $7. The stock is trading this morning at $3.14 with a market cap of only $85 million. Data from a Phase II study combining the drug with Avastin is expected in the first half of next year. And the company says it has enough cash on hand to fund operations into 2017.
"Preclinical data generated by AstraZeneca with the LYNPARZA-CRLX101 combination demonstrate the synergistic anti-tumor effect of targeting two validated pathways," said the CEO in a statement. "While PARP-Top1 combos have traditionally been limited by toxicity, we believe that our NDC and the work AstraZeneca carried out to define a dose and schedule that could be taken into the clinic may allow for the LYNPARZA-CRLX101 combination to be delivered safely and effectively."
- here's the release