Jobs Lost as Cellectar Biosciences Shutters Manufacturing Operations
Published: Jan 09, 2018 By Mark Terry
Cellectar focuses on developing phospholipid drug conjugates (PDCs) to provide cancer targeted delivery of chemotherapeutics to a range of cancer types. Its lead product, CLR 131, uses iodine-131, a cytotoxic radioisotope, as its payload. It is being studied in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma and in a Phase II clinical trial in B-cell malignancies.
The manufacturing shutdown and layoffs are expected to cost the company about $1.4 million. “It allows us to invest precious dollars and resources in our science,” said Jim Caruso, Cellectar’s chief executive officer, to Xconomy. He added that the decision to close its local manufacturing operations was because it was “difficult to justify maintaining a pretty significant footprint and space” at its headquarters in Madison.
It will contract out the manufacturing to the Ontario, Canada-based Centre for Probe Development and Commercialization. Cellectar has been working with them since late 2016.
On Dec. 14, 2017, Cellectar filed an Investigational New Drug (IND) application with the Division of Oncology at the U.S. Food and Drug Administration (FDA). It was for a Phase I trial of CLR 131 in children and adolescents with various rare and orphan designated cancers. About 30 children and adolescents with neuroblastoma, sarcomas, and lymphomas including Hodgkin’s lymphoma, as well as brain tumors, will be evaluated for safety and tolerability of a single intravenous administration of the drug. Preliminary antitumor activity is a secondary endpoint, as well as to identify the recommended dose for a Phase II trial.
The trail will be conducted with pediatric oncologists and Nuclear Medicine/Radiology Group at The University of Wisconsin Carbone Cancer Center.
“The University of Wisconsin group makes an ideal partner for the development of CLR 131 in pediatric cancers because of the quality of their investigators, prominence as a leading U.S. pediatric treatment center and extensive experience with beta-emitting radioisotope therapies,” said John Friend, Cellectar’s chief medical officer, in a statement. “Together, our hope is to bring new and effective treatment options for children battling life-threatening cancers.”
Only a week or so earlier, the company announced it was increasing the enrollment in its Phase II trial of CLR 131 for relapsed/refractory (R/R) multiple Myeloma (MM). Data from the MM arm of the trial showed that it “exceeded pre-specified criteria for clinically meaningful benefit.”
“The initial results from the multiple myeloma arm of this Phase II study underscore the potential for CLR 131 to benefit these heavily pre-treated and relapsed patients,” Caruso said in a statement. “We continue to see clinical benefit with CLR 131 in both our Phase I and Phase II clinical studies and look forward to reporting additional data from both of these clinical studies next year. Furthermore, we are pleased to have achieved this key clinical milestone within our projected timelines.”
The Phase II trial is being performed in about 10 cancer centers across the U.S.