Seneca Biopharma has completed a stem cell-based therapy manufacturing facility to support clinical trials in Suzhou, China.
The initial focus is Seneca’s candidate stem cell therapy, NSI-566, which is in a Phase II trial at the BaYi Brain Hospital in Beijing for chronic ischemic stroke.
Thomas Hazel, Seneca’s senior vice president of R&D told us “The facility is designed to support clinical trial needs including our ongoing trial which will provide data this year in chronic ischemic stroke, not commercialization.
“We are employing single-use technologies for manufacturing,” he added.
NSI-566 is composed of human spinal cord derived neural stem cells. After injection the cells are able to differentiate into a variety of cell types, including those damaged in stroke patients.
According to a paper published in 2018 the original neural stem cells were isolated by dissociating a single piece of spinal cord tissue of lower cervical upper thoracic region and expanding it as a single line.
Three-tiered cell banks, consisting of a master cell bank (MCB), a working cell bank (WCB), and a clinical cell bank (CCB), were established and cryopreserved under cGMP.
ALS talks with US FDA
Completion of the stem cell production facility comes weeks after Seneca said it received positive feedback from a meeting with the US FDA.
The discussion focused on Seneca’s plan for a Phase III trial of NSI-566 in amyotrophic lateral sclerosis (ALS).
At the time it said, “As a result of the discussion and feedback received from the FDA, Seneca believes that the existing Phase I and II trial results support moving into a Phase III clinical study for ALS.”
Seneca was known as Neuralstem until last October.
It rebranded after shifting focus away from the development of neural stem cell treatments and initiated an out-licensing effort.
The new facility is part of that process according to Hazel, who said, “We are looking to partner or out-license the program, and our expectation is that the completion of this facility will support these objectives.”
Seneca established a clinical grade manufacturing facility in China a decade ago.
However, Hazel told us “The previous facility was not ideal for our long-term needs and we anticipated the potential need for increased capacity so we have moved to the new location.”