NW Bio, a Bethesda, Maryland-based company, says it’s getting a “head start” on the manufacturing of DCVax-L and DCVax-Direct as the regulatory requirements for cell therapy products are more rigorous for commercialization than for Phase III trials.
Linda Powers, CEO of NW Bio, told Outsourcing-Pharma.com, “We’ll have topline results by next year and if we meet the endpoint, we’ll submit for product approval.”
She used Denderon as an example of a company that NW Bio has learned from, noting that small biotech companies should not wait to set up the infrastructure necessary to begin commercialization.
As far as the manufacturing process for the two products, Powers mentioned that ten years ago it took five months to manufacture the immunotherapies and now it takes eight days. In addition to the efficiencies, “there’s high purity as well…that’s the dramatically positive results you get if you focus on the practical aspects.”
NW Bio chose Cognate because it’s a sister company with common shareholders, in addition to having a decade-long relationship. “If you look around – should you do it all yourself or hire a specialists? And again we think one of the things that contributed to Denderon’s difficulties ” was the idea that they could do it alone, she noted.
The agreements with Cognate allow NW Bio to begin a scale-up program for expanding clinical programs in the US and Europe, and for any compassionate use programs or other early access or expanded access programs which the company might undertake. They also allow for long-term preparations for potential commercialization and product validation.
“I don’t want to give people the wrong impression but we want to take it into a number of different regions, especially those with regulatory pathways that can accelerate cell therapy products,” such as in Japan, Australia and Singapore, Powers said.
“We are excited to enter into a broad program to expand capacity and build large scale infrastructure, systems and operations under these Agreements with Cognate,” commented Les Goldman, Senior VP of business development at NW Bio.