Novartis signs Regenerex deal
pharmafile | September 9, 2013 | News story | Sales and Marketing | CLL, Novartis, kidney, regenerex
Novartis has signed a deal with US biopharma firm Regenerex to use its novel stem cell-based platform, which may have a key application in helping kidney transplant patients.
The Kentucky-based firm’s novel Facilitating Cell Therapy (FCRx) platform is the subject of the global licensing and research collaboration, which will see Novartis examine its potential benefit in a variety of areas.
Transplant patients currently have to take immunosuppressive drugs for life to prevent the body from rejecting the donated organ.
Using FCRx, a Phase II study in 15 kidney transplant recipients showed that six patients were able to withdraw from this therapy with no ill effects, and two more were in line to give up such drugs at one year.
There is the possibility that this approach could be expanded to treat inherited metabolic conditions like metachromatic leukodystrophy or sickle cell disease.
The idea behind FCRx is that – as it contains cells derived from a donor – it can support the development of bone marrow chimerism (tolerance) in transplant recipients, providing fewer side effects than current human haematopoietic stem cell transplantation techniques.
For Novartis the deal is a chance to augment its cell therapy portfolio, which includes two novel platforms which are already being investigated in hematological malignancies.
HSC835, a novel cell therapy approach allowing an expanded single umbilical cord blood-derived hematopoietic stem cell transplant in patients with limited treatment options, is currently in Phase II.
Meanwhile Novartis is looking at CTL019, a chimeric antigen receptor T cell therapy, in Phase II studies in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).
The company has been keen to reference its own historical work in the field when announcing the Regenerex agreement.
“Thirty years ago, Novartis developed ciclosporin, which changed transplantation treatment paradigms and enabled countless lives to be saved,” said Timothy Wright, the company’s global head development. “Now, this collaboration, along with our internal cell therapy assets, has the potential to transform medicine once again through innovation.”
Adam Hill
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