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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 2017-10-30T09:08:09+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 2017-10-30T09:08:09+00:00

ViaCyte Featured in PharmaVOICE’s Innovator’s Corner

PharmaVOICE talked with Dr. Paul Laikind, ViaCyte’s President and CEO, about how the company is developing a unique stem cell-derived therapy for type 1 diabetes.  Type 1 diabetes affects an estimated 1.25 million people in the US, many of whom suffer from severe complications including kidney failure, heart disease, and stroke.

Type 1 diabetes occurs when the body attacks and destroys the insulin-producing beta cells in the pancreas.  These cells produce insulin in response to high levels of glucose (sugar) in the bloodstream.  Improperly regulated blood glucose can cause loss of consciousness, coma, and even death.  Replacing insulin through injections helps people with type 1 diabetes manage their blood glucose levels.

ViaCyte is developing PEC-EnCap (also known as VC-01), a first-in-class product candidate designed to provide replacement pancreatic islet cells, including the insulin-producing beta cells.  ViaCyte’s product candidate comprises pancreatic precursor cells made from human stem cells and a semi-permeable pouch that protects these cells from the body’s immune system.  After the pancreatic precursor cells in the pouch are implanted under the skin, they are designed to mature into functioning pancreatic islet cell types that produce insulin and other blood-glucose regulating hormones.  PEC-EnCap is currently being tested in a Phase 1/2 clinical trial, and preliminary results have been promising.

Read more in PharmaVOICE.

ViaCyte Featured in PharmaVOICE’s Innovator’s Corner 2017-10-30T09:08:09+00:00

ViaCyte Acquires Rights to BetaLogics Assets

For more than a decade, ViaCyte and BetaLogics have been independently working toward a stem cell-derived therapy for diabetes.  In February of 2016, ViaCyte and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, agreed to consolidate the assets of the Janssen BetaLogics group into ViaCyte.

As Paul Laikind, Ph.D., ViaCyte President and CEO, explained to FierceBiotech, “By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on insulin-dependent diabetes and solidify our leadership in the field.”

The acquisition occurred as ViaCyte reported positive preliminary results in the first clinical trial of a stem cell-derived therapy in patients with type 1 diabetes.  Diego Miralles, global head of innovation at Johnson & Johnson San Diego, told FierceBiotech that these results showed “it’s clear that ViaCyte has pulled ahead (of BetaLogics).”

Read more in Fortune, Xconomy, California Stem Cell Report, and FierceBiotech.

ViaCyte Acquires Rights to BetaLogics Assets 2017-10-30T09:08:09+00:00

ViaCyte Reports Promising Preliminary Results

ViaCyte reported positive preliminary results from the Company’s Phase 1/2 clinical trial of PEC-EnCap (also known as VC-01) product candidate.  The company is the first to advance an encapsulated islet cell replacement therapy for type 1 diabetes into clinical trials.

NBC interviewed ViaCyte’s President and CEO, Dr. Paul Laikind, who explained that “ViaCyte hopes to turn (type 1 diabetes) into a disease that patients don’t have to think about.”

To achieve this goal, ViaCyte has differentiated pancreatic precursor cells from a human stem cell line.  ViaCyte has also developed an encapsulation device to protect the cells from the immune system once implanted into a patient.

Dr. Laikind explains, “These cells are human cells, but they’re not the patient’s cells, so the patient’s immune system would want to remove those cells – attack those cells.”

The encapsulation device is also semi-permeable allowing oxygen and nutrients to flow to the implanted cells, and the diffusion of blood-glucose regulating hormones produced by the cells into the patient’s blood.

Once implanted, the cells are designed to differentiate into the various cell types that make up the pancreatic islet, which could allow for production of insulin and other hormones, such as glucagon, needed to control blood sugar levels.

While discussing preliminary clinical trial results, Dr. Laikind told Xconomy that “Three months after implantation, the cells are surviving, they are proliferating…the device is vascularized, and they are differentiating.”

Xconomy also interviewed Derek Rapp, president and CEO of JDRF, who said that these results “move us closer to our goal of a world without type 1 diabetes.”

Randy Mills, president of the California Institute for Regenerative Medicine told California Stem Cell Report that “the latest clinical data from ViaCyte are very encouraging and a clear sign of progress.”

Read more in NBC, Fortune, San Diego Business Journal, and Xconomy.

ViaCyte Reports Promising Preliminary Results 2017-10-30T09:08:09+00:00