The Cell and Gene Therapy Catapult (CGT) has teamed up with the University of Aberdeen to found Islexa, a startup focused on hustling a cell therapy for Type I diabetes into the clinic. Islexa’s founders think the technology could dramatically increase the number of patients who can receive transplants of insulin-producing islets.
As it stands, the U.K. performs around 50 islet transplants a year, a figure that is constrained by a lack of donated islets and the risk of complications associated with the procedure and the long-term use of immunosuppressants it requires. A desire to find solutions to these problems has attracted heavy hitters such as Johnson & Johnson ($JNJ), which ran an in-house program before pooling resources with ViaCyte earlier this year. The ViaCyte approach, which is already in the clinic, starts with human embryonic stem cells.
Islexa is pursuing a different approach to the same problem. “The technology essentially takes the exocrine tissue from donated pancreas, once the islets have been removed from it, ... reprograms it and forward differentiates it from a kind of mesenchymal stem cell state. That makes functional islets,” CGT CEO and Islexa Director Keith Thompson told FierceBiotech.
Islets are organoids found in the pancreas. Insulin-producing beta cells make up around 70% of the content of an islet. The remaining 30% is largely made up of alpha and delta cells, which, respectively, produce the peptide hormones glucagon and somatostatin. Both of the hormones are involved in the feedback system that regulates blood sugar levels.
Islexa thinks it can replicate this composition. “What's really excited us is that not only do these things looks like islets and have the full mix of cells that islets have, but the tests that we've had show they do biphasic insulin production ... at the kind of levels and quantities that are seen in normal islets,” Thompson said.
Kevin Docherty, the University of Aberdeen professor involved with the founding of Islexa, published details of the approach in the journal Diabetes in 2013. And Thompson and the rest of CGT have seen enough potential in the process to bankroll its advance into the clinic.
Before then, Islexa needs to build the preclinical safety case for its islets and bring its process up to the scale and standard needed for human trials, tasks Thompson expects to take two to three years. “Our aim is to get into first-in-man studies. And then of course we'll be looking for more investment after that,” he said.
Islexa is currently relying on Docherty’s lab and CGT staffers to carry out the preclinical work, but it will start to transition away from this fully virtual model as the program advances. Once the program gets toward the clinic, Thompson expects Islexa to benefit increasingly from its ties to the Scottish transplant and academic sectors, members of which will carry out the first-in-human study. “It's a very, very experienced group that are doing the work,” he said.
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