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ViaCyte Receives $10M in Financing and ‘Go-ahead’ for Clinical Trials with PEC-Direct

With $10 million raised in financing and the ‘go-ahead’ from both the U.S. Food and Drug Administration (FDA) and Health Canada, ViaCyte is ready to begin human clinical trials of the PEC-Direct product candidate.

The PEC-Direct product candidate is designed to allow blood vessels to directly interact with the pancreatic progenitor cells contained inside the device.  As such, PEC-Direct will require immunosuppression therapy, and is being developed for type 1 diabetes patients that are at a higher risk of death due to complications, such as severe hypoglycemic episodes, extreme glycemic lability and hypoglycemia unawareness.

When asked about working with the FDA for initiation of this clinical trial, president and CEO, Paul Laikind, Ph.D., told Medical Device Daily, “The FDA recognizes that we’re breaking new ground here and they are very engaged in what we’re doing.”

FierceBiotech reported the funding comes from Gore, who ViaCyte partnered with in March, JDRF and Asset Management Partners as well as one other undisclosed investor.  Some of this funding will also be used to support the development of ViaCyte’s other product candidate, PEC-Encap.

Read more about these announcements in CIRM’s The Stem Cellar, FierceBiotech, Medical Device Daily (subscription required), The Wall Street Journal, and Xconomy.

ViaCyte Receives $10M in Financing and ‘Go-ahead’ for Clinical Trials with PEC-Direct 2017-06-27T10:21:54+00:00

ViaCyte to Present at ARM’s 5th Annual Cell & Gene Therapy Investor Day in Boston

ViaCyte to also present at World Advanced Therapies and Regenerative Medicine Congress in London

SAN DIEGO, April 24, 2017 ViaCyte, Inc., a privately-held regenerative medicine company, today announced two presentations on April 27 at the Alliance for Regenerative Medicine’s 5th Annual Cell & Gene Therapy Investor Day in Boston.  ViaCyte is developing novel stem cell-derived islet replacement therapies for insulin-requiring diabetes.  The company’s lead PEC-DirectTM product candidate is entering clinical development as a potential functional cure for patients with type 1 diabetes with the highest risk of life threatening acute complications.  The related PEC-EncapTM product candidate in development has the potential to provide a functional cure for essentially all patients with type 1 diabetes as well as become an important therapy for patients with type 2 diabetes that depend on insulin to help control their disease.

A live webcast at the 5th Annual Cell & Gene Therapy Investor Day will be available at the time of the presentations here: http://www.arminvestorday.com/webcast.

ViaCyte will also present at the upcoming World Advanced Therapies and Regenerative Medicine Congress in London on May 19.

Details of the presentations are as follows:

Event:                         5th Annual Cell & Gene Therapy Investor Day
Speaker:                     Dr. Paul Laikind, President and Chief Executive Officer
Panel:                         Cell Therapy Beyond Oncology: Where Does the Greatest Potential Lie?
Date/Time:                 April 27, 10:25 AM EDT
Location:                    The State Room, Boston

Event:                         5th Annual Cell & Gene Therapy Investor Day
Speaker:                     Dr. Mark Zimmerman, Vice President, Strategy and Business Development
Fireside Chat:            Hosted by Edward Tenthoff, Managing Director & Sr. Research Analyst, Piper Jaffray
Date/Time:                April 27, 5:00 PM EDT
Location:                   The State Room, Boston

Event:                        World Advanced Therapies and Regenerative Medicine Congress
Speaker:                    Dr. Mark Zimmerman, Vice President, Strategy and Business Development
Date/Time:                May 19, 9:40 AM BST
Location:                   Business Design Centre, London

For more information about ViaCyte’s participation in industry events, please visit: http://viacyte.com/news-events-2/viactye-events/

About ViaCyte

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells, which are then implanted in  durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two products in development.  The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device that allows direct vascularization of the implant in order to insure a robust and consistent engraftment and is being developed for type 1 diabetes patients who have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired awareness of hypoglycemia.  The PEC-Encap™ (also known as VC-01) product candidate is designed to deliver the same pancreatic progenitor cells in an immunoprotective device and is currently in active development as a therapy for all patients with type 1 diabetes as well as insulin requiring patients with type 2 disease.  ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

ViaCyte to Present at ARM’s 5th Annual Cell & Gene Therapy Investor Day in Boston 2017-04-24T06:08:21+00:00

ViaCyte Establishes Collaborative Research Agreement with Gore

As the first company to advance a cell replacement therapy for type 1 diabetes into the clinic, ViaCyte is committed to developing a functional cure for all type 1 diabetes patients.  As part of the product development work, ViaCyte entered into a collaborative research agreement with materials science company W.L. Gore & Associates (“Gore”) to improve the Company’s novel implantable cell therapy delivery devices.

The PEC-Encap product candidate is made of two separate components: 1) PEC-01 pancreatic progenitor cells, which are designed to differentiate into all of the cells of the pancreatic islet after implantation, and 2) the Encaptra Cell Delivery Device, a macro-encapsulation device that has been shown to protect the delivered cells from the host patient’s immune system. Positive preliminary clinical data from the STEP-ONE clinical trial with the PEC-Encap product candidate showed, once implanted, the Encaptra Device protects the PEC-01 cells from the immune system and the cells were capable of differentiating to beta cells when evidence of vascularization and engraftment was observed. However, vascularization and engraftment was found to be inadequate. ViaCyte believes that improvements to the macroencapsulation device could make the vascularization and engraftment more robust and consistent.

President and CEO, Paul Laikind, Ph.D., told Xconomy, “We needed to improve the ability to vascularize across the surface of that [device] membrane, and that’s where Gore comes in.”  The goal is to combine Gore’s expertise in engineering biocompatible materials with ViaCyte’s experience in cell therapeutic approaches to make the PEC-Encap product candidate a more effective therapy for all patients with type 1 diabetes.

While these improvements in PEC-Encap are taking place, ViaCyte is continuing to move forward with their product candidate for the patients with the greatest need, called PEC-Direct.  The PEC-Direct product candidate has the same PEC-01 cells, but the encapsulation device is engineered with larger pores to allow blood vessels to directly contact the cells, which it is expected to allow for robust vascularization and engraftment.  The PEC-Direct product has the potential to complete clinical trials first and be a functional cure for type 1 diabetes patients with severe life-threatening hypoglycemia unawareness and related risks.

Read more about the collaboration with Gore in FierceBiotech, MedCity News, Medical Device Daily (subscription required), and Xconomy.

ViaCyte Establishes Collaborative Research Agreement with Gore 2017-06-18T20:37:05+00:00