Stem cell player ViaCyte expands collaboration with Gore to develop subcutaneous diabetes treatment
Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.
Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.
Such responses “basically can lead to a deposition of what’s called foreign-body giant cells on the surface of the device” and interfere with its processes, Laikind told Endpoints News. ViaCyte and Gore’s focus is cutting these reactions out entirely.
The product is designed to be implanted underneath the skin and deliver pancreatic progenitor cells that can secrete insulin and control blood glucose levels, in essence becoming functional tissue. Not only do the companies aim to provide this treatment but also protect the cells from the hosts’ immune systems, as the membrane allows for the creation of a vascular network on the surface of the device.
“Those pancreatic cells stay in the device, and we’re essentially replacing the normal human cells that are lost or dysfunctional in diabetes patients,” said ViaCyte CSO Kevin D’Amour. “They’re beholden to injecting exogenous insulin to control their blood sugar.”
Even though Laikind said the goal is to, essentially, cure type 1 diabetes by way of these cell and hormone replacements, the companies would be content by simply reducing the need for injectable insulin use as that would still constitute a significant therapeutic advance.
Erin Hutchinson, a business leader at Gore, said the tricky part in creating the right kind of membrane is getting the level of permeability exactly correct.
“You don’t want the cells inside to escape and you don’t want the immune system to get in,” Hutchinson said. “On the other hand, you do want to allow for transport, for things like oxygen, insulin, glucose, etc. And so that’s kind of the challenge, designing a membrane as part of an overall device that can do that.”
Stem cell R&D had been a hype train in early investments but has since turned into a long-running affair, and ViaCyte is no different from other such biotechs in this regard. The company had attempted pairing its stem cell technology with a different membrane before, but ran into trouble when patients developed those foreign body responses. That led them to collaborate with Gore, which first signed on to an agreement in 2017 and then chipped in with $10 million as part of a larger ViaCyte funding round in November 2018.
Phase I/II clinical trials of PEC-Encap with the new membrane are underway after some delays related to Covid-19. Early indications are promising, Laikind said, but the companies still need to go down the path of commercialization.
“The immune response is pretty consistent among patients, certainly some will react more aggressively than others,” Laikind said. “But the design of the device is meant to protect the cells from the immune response of any patient … We really believe we’re down to the final step toward a commercial product in proving the effective delivery of grafting.”