Industry Update: Capital market and finances

Written by Dusko ILIC
Industry developments Journal articles Spotlight on cell therapy regulation

Latest market and finance developments compiled from July 01 — August 31 2016

Latest capital market and finance developments in the field of stem cell research
and regenerative medicine compiled from publicly available information
and press releases from non-academic institutions from July 01 — August
31 2016, scheduled to be published in Volume 11 Issue 8 of Regenerative Medicine.

AiVita

AiVita Biomedical (CA, www.aivitabiomedical.com) announced that the California Institute for Regenerative Medicine (CIRM; CA, www.cirm.ca.gov) has awarded a grant of circa USD 4 million and approved the collaboration with the University of California, Irvine (UCI; http://stemcell.uci.edu), for the development of stem cell-derived 3D-transplantable retinas to treat vision loss. Safety and efficacy of 3D-retinal organoids consisting of human stem cells differentiated into sheets of retinal tissue will be tested by UCI in relevant models of retinal degeneration, such as models of macular degeneration and retinitis pigmentosa.

HumaCyte

Humacyte® (NC, USA; www.humacyte.com), has received a grant of nearly USD 10 million from the California Institute for Regenerative Medicine (CIRM; CA, www.cirm.ca.gov). The grant, payable in installments upon satisfaction of certain milestones, will help fund a Phase III clinical trial which commenced in May 2016 on Humacyte’s investigational human acellular vessel (HAV), HUMACYL®. Humacyte’s HUMANITY® trial will compare HUMACYL to expanded polytetrafluoroethylene (ePTFE) grafts, the standard of care for End-Stage Renal Disease (ESRD) patients undergoing hemodialysis not suitable for fistula. The trial will be conducted across approximately 35 sites in the US, Europe and Israel with 350 evaluable subjects, making it the largest study of any bioengineered vascular tissue to date. HUMACYL received Fast Track status from the FDA in 2014.

Viacyte

ViaCyte (CA, USA; http://viacyte.com) has been granted USD 3.9 million from the California Institute for Regenerative Medicine (CIRM; CA, www.cirm.ca.gov) to support preclinical development of ViaCyte’s pancreatic endoderm cells (PEC)-Direct cell therapy product candidate which is being developed for a subset of type 1 diabetes patients. The PEC-Direct product candidate delivers stem cell-derived PEC-01 in a device designed to allow direct vascularization of the cells, and is being developed for type 1 diabetes patients that have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired awareness of hypoglycemia. This direct vascularization is expected to allow for a robust engraftment and cellular performance similar to the anatomy of a normal islet. Given the open nature of the device, patients implanted with PEC-Direct, as with other transplants, would require chronic immune suppression. ViaCyte has two products in development. The other product candidate, PEC-EnCap (formerly VC- 01â„¢), delivers PEC in the Encaptra® immunoprotective device, and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin ViaCyte producing beta cell function.