SymbioCellTech Demonstrates Preclinical Efficacy of Proprietary and Novel Human Neo-Islets™ Technology in STZ-Diabetic NOD-SCID Mice

Clinically relevant model validates Neo-Islets™ as a durable and potentially curative therapy for Type 1 Diabetes that does not require toxic anti-rejection drugs

SALT LAKE CITY, Oct. 28, 2021 (GLOBE NEWSWIRE) -- SymbioCellTech (SCT) announced today the publication of a paper demonstrating the potency and efficacy of its innovative and proprietary human Neo-Islet™ in a third, clinically relevant model of human Type 1 Diabetes (T1D). Published in PLOS ONE, the paper describes SCT's creation of a "new endocrine pancreas" that delivers islet hormones into the hepatic portal vein. This is the only non-transplant therapy to provide physiologic delivery of insulin and other islet hormones without the need for non-cellular encapsulation devices or anti-rejection drugs.

Christof Westenfelder, MD, founder and CEO of SCT, stated, "We continue to advance our durable cure for those suffering from Type 1 Diabetes towards investigation in a Phase I Clinical trial and the curative effect of human Neo-Islets™ in STZ-diabetic NOD/SCID mice adds further support to our translational expectations of the therapy." Westenfelder added, "We're excited to bring forward a durable mechanism of insulin delivery through particular insights into Mesenchymal Stromal/Stem Cells, the most exquisite of encapsulation technologies." The design of Neo-Islets™ provides permanent auto-immune and allo-immune isolation, a critical activity that most other encapsulation technologies lack because they induce a foreign body reaction that leads to failure of the transplant.

Previously, in an article published in Stem Cells Translational Medicine, the SCT team demonstrated allogeneic Neo-Islets™ (three-dimensional organoids composed of approximately equal numbers of Mesenchymal Stromal Cells and culture-expanded Islet Cells) permanently restore blood sugar levels to normal in diabetic NOD mice after spontaneous engraftment of Neo-Islets™ into the omentum. Furthermore, in an article published in PLOS ONE, treatment of insulin-dependent pet dogs with allogeneic canine Neo-Islets™ (ongoing FDA-INAD Pilot Study being conducted in a clinical setting) showed stable and durable statistically significant reduction in need for insulin, as well as consistently improved glycemic control without antirejection drugs.  

Anna Gooch, PhD, Chief Scientific Officer, commented, "The fact that our human Neo-Islet™ has a similar gene expression profile to that of our dog and mouse Neo-Islets™ further suggests this therapy holds promise for successful translation to the clinic." 

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Virbac and Symbiocelltech sign exclusive option agreement to develop novel technology for treatment of type 1 diabetes in companion animals.

SALT LAKE CITY, UT, USA and CARROS, France, January 12, 2020 – SymbioCellTech, LLC (SCT), a biotechnology company in Salt Lake City, pioneering stem cell therapy for diabetes, sign with Virbac (VIRP), the world’s sixth largest veterinarian pharmaceutical group, an agreement for the co-develop and commercialize their proprietary “Neo-Islet” cellular therapy to treat animals suffering from insulin-dependent diabetes.

Type-1 Diabetes Mellitus (T1DM) is a disease in which the islet cells of the pancreas fail to produce the essential hormone, insulin. Approximately one dog in 3001 develops it. Currently, the standard therapy for T1DM in companion animals includes blood glucose monitoring and subcutaneous injection of insulin. However, this approach is cumbersome and expensive with most animals continuing to suffer from sub-optimal compliance to the drug administration regime and from long-term complications from the disease inducing a shortened life expectancy. 

“Neo-Islets” are small cellular clusters easily administered into the abdominal cavity in an outpatient procedure, which provide durable blood sugar control without the need for subcutaneous insulin, toxic anti-rejection drugs or encapsulation devices. In order to avoid the need for immunosuppressive agents to prevent rejection of this long-lasting cellular therapy, scientists at SymbioCellTech have employed adult mesenchymal stem cells to block the immune attack on transplanted pancreatic islet cells, a proprietary and patented process they term “natural encapsulation.” Also, by using this approach rather than placing an artificial delivery device in the body, the Neo-Islets do not mount a foreign body reaction that often leads to therapy failure. Neo-Islets are biologically pure cellular structures that possess all functions of normal pancreatic islet cells, while permanently shielding their pancreatic islet cell component from rejection and immune-mediated destruction. “SCT-c001” is Neo-Islets formulated specifically to treat dogs with insulin dependent DM. It was initially tested under an Investigational New Animal Drug (INAD) in a small number of insulin dependent pet dogs where it demonstrated promising long-lasting efficacy and an excellent safety profile.

“Even if the research and development will take time and prove complex, this agreement opens a very new and promising door for pet owners throughout the world, ultimately giving them the chance for a one-time therapy for their diabetic companion animals, which eliminates daily glucose monitoring and insulin injections, while hopefully avoiding the many complications of long-term diabetes,” said Russ Reiss, MD, Chief Operating Officer of SymbioCellTech. 

In conclusion, a partnership dedicated to animal health! Thanks to the new "Neo-islets" therapy, entirely biological, created by SymbioCellTech and in co-development for marketing by Virbac, this solution has the potential to revolutionize the global treatment of T1DM in animals.

1 Canine diabetes mellitus; can old dogs teach us new tricks? Catchpole B, Ristic JM, Fleeman LM,Davison LJ. Diabetologia 48:1948-1956, 2005.

Interim report on the effective intraperitoneal therapy of insulin-dependent diabetes mellitus in pet dogs using “Neo-Islets,” aggregates of adipose stem and pancreatic islet cells (INAD 012-776)

Anna Gooch, Ping Zhang, Zhuma Hu, Natasha Loy Son, Nicole Avila, Julie Fischer, Gregory Roberts, Rance Sellon, Christof Westenfelder

Abstract

We previously reported that allogeneic, intraperitoneally administered "Neo-Islets," composed of cultured pancreatic islet cells co-aggregated with high numbers of immunoprotective and cytoprotective Adipose-derived Stem Cells, reestablished, through omental engraftment, redifferentiation and splenic and omental up-regulation of regulatory T-cells, normoglycemia in autoimmune Type-1 Diabetic Non-Obese Diabetic (NOD) mice without the use of immunosuppressive agents or encapsulation devices. Based on these observations, we are currently testing this Neo-Islet technology in an FDA guided pilot study (INAD 012-776) in insulin-dependent, spontaneously diabetic pet dogs by ultrasound-guided, intraperitoneal administration of 2x10e5 Neo-Islets/kilogram body weight to metabolically controlled (blood glucose, triglycerides, thyroid and adrenal functions) and sedated animals. We report here interim observations on the first 4 canine Neo-Islet-treated, insulin-dependent pet dogs that are now in the early to intermediate-term follow-up phase of the planned 3 year study (> 6 months post treatment). Current results from this translational study indicate that in dogs, Neo-Islets appear to engraft, redifferentiate and physiologically produce insulin, and are rejected by neither auto- nor allo-immune responses, as evidenced by (a) an absent IgG response to the allogeneic cells contained in the administered Neo-Islets, and (b) progressively improved glycemic control that achieves up to a 50% reduction in daily insulin needs paralleled by a statistically significant decrease in serum glucose concentrations. This is accomplished without the use of anti-rejection drugs or encapsulation devices. No adverse or serious adverse events related to the Neo-Islet administration have been observed to date. We conclude that this minimally invasive therapy has significant translational relevance to veterinary and clinical Type 1 diabetes mellitus by achieving complete and at this point partial glycemic control in two species, i.e., diabetic mice and dogs, respectively.

Full article here: https://dx.doi.org/10.1371%2Fjournal.pone.0218688

SymbioCellTech Completes Pre-IND Meeting with FDA: Critical Step Toward Human Trials

SALT LAKE CITY, September 5th. SymbioCellTech (SCT) and the FDA completed a successful Pre-IND meeting pertaining to SCT’s proprietary “NeoIslet”cell therapy for Type I Diabetes. The regulatory pathway for cellular therapy is long and complicated, requiring extensive in vitro and in vivo pre-clinical studies. SCT has completed much of this work in preparation for upcoming clinical trials and has taken the next step in the pathway by presenting it’s data and plan to the FDA. Feedback from this meeting will shape the regulatory course taken by SCT moving forward. SymbioCellTech is optimistic that First in Human (FIH) clinical trials could begin as early as 2022.

FDA Grants SymbioCellTech Pre-IND Meeting for Novel Neo-Islet Stem Cell Therapy for Diabetes

Earlier this week, SymbioCellTech received confirmation that a Pre-IND Meeting has been granted with the Center for Biologics Evaluation and Research (CBER) at the FDA to discuss plans to move into human clinical trials with Neo-Islet therapy. “This represents another favorable step toward realizing a better therapy and potential cure for millions of people suffering from insulin-dependent diabetes,” states Christof Westenfelder, MD, Chief Executive Officer of SymbioCellTech, LLC.

Pre-IND Package Submitted to Center for Biologics Evaluation and Research (CBER) by SymbioCellTech

Today, June 20th, 2019, the FDA’s Center for Biologics Evaluation and Research (CBER) confirmed receipt of SymbioCellTech’s Pre-IND Package notifying the company that a decision on scheduling a meeting this summer to discuss human Neo-Islet therapy will be communicated by July 8th.

This Pre-IND submission and interaction with the agency represents another milestone achieved toward SymbioCellTech initiating clinical trials, which are currently planned to begin in 2020.

SymbioCellTech Scientific Team Presents Neo-Islet Data at ADA 2019

Drs. Westenfelder and Gooch presented their SymbioCellTech scientific work on Neo-Islet therapy at the 79th Scientific Sessions of the American Diabetes Association (ADA 2019). In independent presentations, Dr. Westenfelder delivered a moderated talk entitled, INAD 012-776 Pilot Study: Allogeneic “Neo-Islets,” Composed of Mesenchymal Stem and Islet Cells, are Immune Protected and Dose-Dependently and Durably Control Autoimmune T1DM in Pet Dogs, and Dr. Gooch presented a poster entitled, Optimal Control of Glucose and Lipid Profiles is Critical to the Effective “Neo-Islet” Therapy of Insulin Dependent Pet Dogs.

Both presentations exemplify significant progress in demonstrating safety and efficacy of SymbioCellTech’s novel Neo-Islet therapy in a large animal model comparable to humans. “This is more validation that the therapeutic discoveries our scientists have made in their relentless pursuit of a cure for diabetes are both safe and feasible for moving into clinical trials,” comments Dr. Russell Reiss, Chief Operating Officer of SymbioCellTech.

Both scientific presentations generated significant interest from other national and international scientific groups, including representatives from both industry and research.

SymbioCellTech Earns Certificate of Achievement for Being Amongst Most Downloaded Papers of 2017 & 2018

Amongst articles published between January 2017 and December 2018, SymbioCellTech’s paper discussing Neo-Islet therapy was one of the most downloaded of all in the 12 months following online publication, generating immediate impact and visibility, and contributing significantly to the advancement of the field of cell therapy and regenerative medicine (see e-letter below).

Dear CHRISTOF WESTENFELDER ,

We are pleased to let you know that your article, Durable Control of Autoimmune Diabetes in Mice Achieved by Intraperitoneal Transplantation of "Neo-Islets,- Three-Dimensional Aggregates of Allogeneic Islet and "Mesenchymal Stem Cells-<onlinelibrary.wiley.com/doi/full/10.1002/sctm.17-0005utm_source=eloqua&utm_medium=email&utm_campaign=W26CS_topauthorq1fy19&utm_content=singletemplateelq_mid=36091&elq_cid=5393580&elqCampaignId=23090&elqTrack=true>, published in STEM CELLS Translational Medicine, is one of the journal's top downloaded recent papers!
* Amongst articles published between January 2017 and December 2018, your paper received some of the most downloads in the 12 months following online publication.
* Your work generated immediate impact and visibility, contributing significantly to the advancement of your field.
In recognition of your work, we’re pleased to offer you a certificate of achievement.
Thank you for helping to grow the profile of our journal so that work like yours is more discoverable.

Best wishes,
STEM CELLS Translational Medicine

SymbioCellTech Greenlighted to Submit FDA Pre-IND to CBER

SymbioCellTech received written notification from the U.S. Food & Drug Administration yesterday that the current state of their Neo-Islet technology was such that an INTERACT meeting was not necessary and SymbioCellTech’s regulatory questions for the agency could be discussed in the context of a Pre-IND meeting. “This represents a significant step toward SCT advancing through the arduous FDA regulatory pathway for biologics and securing additional funding for our upcoming human trials planned to begin in late 2020,” states Russ Reiss, MD, Chief Operating Officer for SymbioCellTech.

SymbioCellTech submits INTERACT Package to FDA Center for Biologics Evaluation and Research (CBER)

After demonstrating initial pre-clinical safety and efficacy in both rodents and pet dogs, today, SymbioCellTech, LLC, a Salt Lake City, Utah based biotechnology company submitted a complete INTERACT Package to the FDA Center for Biologics Evaluation and Research (CBER) in preparation for their Investigational New Drug (IND) application to begin human trials using their proprietary “Neo-Islet” technology to cure Type I Diabetes.