Novo Nordisk plans to file an IND for cell therapy for type 1 diabetes in the next few years, setting the stage for a battle with Vertex which aims to start Phase I/II trials of its candidate this year.

Denmark’s Novo Nordisk shared details of its stem cell-based candidate during its Q4 call recently, explaining it will submit the therapy along with several investigation new drug (IND) applications over the next few years.

CSO Mads Thomsen told analysts “The first indication will be in Parkinson’s disease and not in diabetes. Diabetes is going to come in the second place. This also means that you should imagine an IND towards the end of next year or thereabouts depending on the progress.”

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Spokesman Martin Havtorn Petersen confirmed the plan, telling us “The project is still at a preclinical stage, but we hope to be able to take it into clinical testing in the coming years.”

If the cell therapy progresses, Novo Nordisk plans to make it in-house according to Petersen, who said, “In June 2019 a Novo Nordisk Stem Cell R&D site dedicated to the manufacturing of stem cells and stem cell-based therapies was inaugurated in Fremont California.”

Vertex plans trials

Novo Nordisk’s announcement comes just weeks after the FDA accepted the IND for VX-880, Vertex’s type 1 diabetes cell therapy.

Vertex spokeswoman Heather Nichols told us “We expect to begin the Phase I/II study for VX-880 in the first half of 2021 and we intend to move as quickly as possible to open our clinical sites so that we can begin dosing patients.”

The firm plans to make the product for trials and commercial supply itself according to Nichols, who told us “We are focused on a scalable approach, including the ability to cryopreserve our cells such that they can be thawed on demand.

“Our strong manufacturing team from our acquisition of Semma has been growing to ensure long-term success and are committed to building world-class cell and genetic therapy capabilities through our continued investments in people, facilities and technology.”

She added that, “Our manufacturing approach will be scalable, and will include the ability to cryopreserve our cells such that they can be thawed on demand, hopefully to address some of the shipping challenges.”

Pipeline

VX-880- which was previously known as STx-02, is a stem cell-derived islet cell therapy that is designed to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production.

According to Vertex, the planned trial will involve an infusion of fully differentiated, functional islet cells, as well as the chronic administration of concomitant immunosuppressive therapy, to protect the islet cells from immune rejection.

In addition, Vertex is working on an encapsulated diabetes cell therapy. Nichols told us “In addition to our cells alone approach, we are pursuing another unique therapeutic opportunity for the transplant of the fully differentiated, functional islet cells into patients.

“This second approach, cells in device, involves the implantation of cells inside a novel immunoprotective device that allows the cells to survive and function in vivo without the use of immunosuppressive therapy.

She added, “We are currently working to progress this program through preclinical studies. This approach has the potential to reach a broader range of patients with T1D.”