August 19, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. – Following the failure of its Phase II renal carcinoma trial earlier this week, Cerulean Pharma Inc. is terminating approximately 48 percent of its workforce in an effort to reduce operating expenses as the company refocuses its clinical strategies.
Shares of Cerulean have plunged more than 56 percent on the announcement of the layoffs and the failed clinical trial. The stock is currently trading at $1.20 per share, down from $2.80 per share on Wednesday.
The job loss will impact 23 full-time employees, the company said this morning. Christopher D. T. Guiffre, president and chief executive officer of Cerulean, said the job cuts are “difficult but necessary steps” to take as the company refocuses its priorities on CRLX101.
On Thursday, Aug. 18, the company announced its Phase II trial studying the combination of its lead candidate, CRLX101, in combination with Genentech ’s Avastin (bevacizumab) failed to show a statistical significance in progression free survival when compared to standard care agents such as axitinib, bevacizumab, everolimus, pazopanib, sorafenib, sunitinib and temsirolimus. In fact, patients who received the Cerulean cocktail showed less efficacy than standard choice of care, 5 percent to 14 percent, respectively.
CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. The experimental drug is a topoisomerase inhibitor. The drug inhibits the enzyme that can alter the supercoiled form of a DNA molecule. In earlier trials, CRLX101 has shown activity in multiple tumor types, both as monotherapy and in combination with other cancer treatments. Following the trial failure, Guiffre said the company will continue to focus development of CRLX101 as a treatment option for in topoisomerase 1-sensitive tumors. The company is running additional trials with CRLX101 in combination with other drugs, including paclitaxel and AstraZeneca ’s Lynparza (olaparib). Those two trials are examples of studies that “leverage CRLX101’s topoisomerase 1 inhibition in combination with chemotherapies and DNA damage repair agents,” Guiffre said.
“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,” Guiffre said in a statement.
CRFX101 received orphan drug designation for ovarian cancer from the U.S. Food and Drug Administration as well as 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 renal cell carcinoma.Cerulean said it expects to see about $5 million in reduced annualized operating expenses once the plan is fully implemented. The layoffs are expected to be finalized by the end of this year.
