Localized Modulation of Immune and Inflammatory
Responses for Treatment of Diabetes and Other Conditions

Home2022-01-28T21:17:24+00:00

MISSION AND PURPOSE

It has become increasingly apparent that inappropriate inflammatory and ineffective immune responses are at the center of many chronic disease states.  Direct systemic modulation of these critical pathways however can have severe negative consequences as these are central pathways affecting multiple organ systems.

Vicapsys is focused on leveraging natural pathways in a localized manner in order to achieve beneficial therapies without systemic negative consequences.  At the core of Vicapsys technology is a pleiotropic cytokine, CXCL12 that can be optimally formulated to achieve therapeutic outcomes in different indications.

Vicapsys is currently focused on curing Type 1 diabetes through long-term survival of transplanted islet cells using a formulation that inhibits development of the foreign body response and immune protection.   Vicapsys is also leveraging its core technology to address the consequences of diabetes (diabetic foot ulcers) and the consequences of localized fibrosis (abdominal adhesions).

History

Company History and Highlights

  • Platform technology exclusively licensed from Massachusetts General Hospital in 2013
  • Broad portfolio (8 patent families) of issued and pending applications covering multiple indications/applications of the platform
  • Platform is broadly divided into cellular and non-cellular product lines
  • Cellular applications initially targeted to treatment of Diabetes Mellitus Type 1 through pancreatic islet cell transplantation
  • Feasibility and long-term maintenance of transplanted human islet cells established in non human primate models
  • Other indications include treatment of diabetic foot ulcers and peritoneal adhesions

Management

Federico Pier Managing director of YPH, LLC a Multifamily office investing in Life Sciences, Energy, and Technology. Mr Pier has more than 25 years of experience in reverse mergers, structured finance, convertible debt and straight equity. He has served as a Senior Director at Oppenheimer & Co, and Managing Director at Bear Stearns. He holds a Bachelors’ degree from the University of North Texas and a Master’s of Business Administration from the Graduate School of Management at the University of Dallas. Chief Executive Officer Mark Poznansky, MD, PhD Dr. Poznansky is an Associate Professor of Medicine at Harvard Medical School and Attending Physician in Infectious Diseases Medicine and Director of the Vaccine and Immunotherapy Center at MGH. Dr. Poznansky is the discoverer of the use of AMD3100 for cancer. His laboratory defines molecular mechanisms for novel immune processes and explores the relevance of these mechanisms to novel approaches to vaccines and immunotherapies for cancer and infectious diseases. He is the scientific founder of a number of spinoff biotech companies from MGH including Celtaxsys, ACTx and Vicapsys. Chief Scientific Advisor and Founder Jeffery Wright Mr. Wright is a Certified Public Accountant with 17 years of finance and accounting experience in both the public and private sectors. Mr. Wright joined Vicapsys Life Sciences in June 2019 as the Controller and has served as the Chief Financial Officer since February 2020. Mr. Wright has served in multiple capacities as both the Controller and Chief Financial Officer for both small biotech and technology Companies in various stages of development and has been involved with their exits and mergers. Mr. Wright holds Master of Professional Accountancy and Bachelor of Business Administration degrees from the Georgia State University Robinson College of Business and is a member of the Georgia Society of Certified Public Accountants. Chief Financial Officer

Board of Directors

Federico Pier, Chairman Managing director of YPH, LLC a Multifamily office investing in Life Sciences, Energy, and Technology. Mr Pier has more than 25 years of experience in reverse mergers, structured finance, convertible debt and straight equity. He has served as a Senior Director at Oppenheimer & Co, and Managing Director at Bear Stearns. He holds a Bachelors’ degree from the University of North Texas and a Master’s of Business Administration from the Graduate School of Management at the University of Dallas. Richard Rosenblum Mr. Richard Rosenblum is Innovative Payment Solutions Inc.’s President, Chief Financial Officer, and Director, and has served in these roles since July 22, 2021. Mr. Rosenblum has served on the Board of H-Cyte since February 1, 2022. Since its founding in 1994, Richard has served as Chief Executive Officer and Principal at Harborview Capital Advisors LLC., providing strategic advisory services in capital formation, merchant banking and management consulting. He is the owner of Harborview Property Management where he invests and manages in commercial real-estate. Mr. Rosenblum was a Director, President, and Executive Chairman of Alliqua Biomedical Inc. which developed hydrogel manufacturing technology. He has served on the Board of Directors of the Chilton Hospital Foundation. Mr. Rosenblum graduated Summa Cum Laude from SUNY Buffalo with a B.A. in Finance & Accounting. Dorothy Jordan, DNP Dr. Dorothy Jordan, Board Member - graduated with a BS in Nursing from East Stroudsburg University, a Masters in Child Health from Emory University, a Post-Masters Certificate in Psychiatric Mental Health from Georgia State University, and a Doctor of Nursing Practice from the University of Tennessee Health Science Center. Dr. Jordan served for many years on the Juvenile Diabetes Research Foundation board, the Camp Kudzu board and currently serves on the advisory board of the Emory University Winship Cancer Institute, the Emory University Child and Adolescent Mood Program. Frances Toneguzzo, Ph.D., CEO Dr. Toneguzzo has served in multiple strategic roles including as Executive Vice President, Strategic Alliances at Nantkwest Inc, a clinical stage public cell therapy company in the immune-oncology space, managing corporate and academic alliances and intellectual property protection. She also has served as head of IP strategy for Life Biosciences, developing therapies to enhance longevity. Dr. Toneguzzo previously led Partners HealthCare’s efforts related to international and national collaboration and has unique experience in building and executing high value partnerships to commercialize life science innovations During her 12-year tenure, she increased licensing revenues by a consistent 20% year over year and oversaw the launching of 73 startups in areas such as aesthetic dermatology, diagnostics and pharmaceuticals. She comes from the biotech industry, having played various technical and business development roles. She holds a Ph.D. in Biochemistry from McMaster University in Canada. Colleen Delaney, MD Dr. Colleen Delaney is the Scientific Founder, Chief Scientific Officer, and Executive Vice President of Research and Development at Deverra Therapeutics, Inc., a cellular therapy company focused on the development of universal donor, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases. Additionally, Dr. Delaney is a stem cell transplant physician and an Affiliate and former Professor of the Fred Hutchinson Cancer Research Center, Clinical Research Division, where she was Physician Investigator (PI) of an NIH/government funded laboratory and where she established and became the Director of the Program in Cord Blood Transplant and Cord Blood Research at the Fred Hutch/Seattle Cancer Care Alliance. Dr. Delaney’s research interests focus on the development of methods to expand the number of umbilical cord blood stem cells and to then direct these cells to further differentiate into mature blood and immune cells for clinical application. She has more than 20 years of experience in the development of cord blood derived allogeneic cell therapies from bench to bedside and is an inventor on numerous patents. Dr. Delaney received her MSc from Oxford University, her MD from Harvard Medical School, and is the recipient of numerous awards, including the prestigious Damon Runyon Foundation Clinical Investigator Award; the Dr. Ali Al-Johani Award in recognition of exemplary clinical medical care and compassion to patients and families; the Seattle Business Journal’s Leaders in Health Care Award for Outstanding Medical Research; and the Seattle American Women in Science’s Award for the Scientific Advancement and Leadership in STEM. Charles Farrahar Mr. Charles “Charlie” Farrahar is a Certified Public Accountant with over 30 years of managerial finance, administration, human resource, investor relations, and risk management experience in the public, private and non-profit sectors. Mr. Farrahar served as the Chief Financial Officer of ViCapsys from its inception in 2014 through its merger with SSGI to become a public entity. He has served as CFO for several small biotech startups in various stages of development and has been involved with their exits or mergers. Currently he serves as CFO for a privately-held biotech company headquartered in Rochester, MN that licenses a platform technology from Mayo Clinic. In addition to his prior work with ViCapsys, Mr. Farrahar was the CFO of Credit Depot Corp, Medovex Corp, and Roadie Inc. Mr. Farrahar received his B.B.A. in Accounting from Georgia State University.

LEVERAGING THE BODY’S NATURAL MECHANISMS

Multiple activities of CXCL12 for different applications

Key CXCL12 Discoveries

  • Repulses Effector T cells and recruits Regulatory T cells to create an immune-privileged environment
  • Permits and promotes the survival of transplanted β-Islet cells
  • Promotes Anti-inflammatory and subsequently anti-fibrotic processes preventing post-surgical adhesions
  • Promotes angiogenesis and recruits endogenous stem cells for the promotion of wound healing

Schematic of the CXCL12 Cellular Actions

Two Product Lines

CXCL12 Protects Insulin Producing Cells

 

CXCL12-BASED  THERAPIES IN DEVELOPMENT

ViCapsyn™

DIABETES TREATMENT BY β ISLET STEM CELL TRANSPLANTATION
Allogenic Human Stem Cells differentiated into β-cells to produce Insulin

  • Transplanted in a matrix of an alginate containing CXCL12
  • Rodent and NHP results indicate cell survival and glucose modulating function up to 6 months posttransplantation

ViBrin™

TO ACCELERATE HEALING OF DIABETIC FOOT ULCERS (DFUs)

  • CXCL12 complexed into a bioabsorbable polymer and applied directly to the DFU following debridement surgery
  • Inhibit inflammation, promote stem cell recruitment, angiogenesis to accelerate ulcer healing

ViBrin™

INHIBITING ADHESIONS POST-PERITONEAL SURGERY

  • CXCL12 formulated in a bioabsorbable, moldable polymer applied to the incision site
  • Inhibit inflammation and block formation of adhesions

THERAPEUTIC APPLICATIONS

ViCapsyn™ Treatment of Type 1 Diabetes

Diabetes Market Scope

  • The global treatment market for type 1 diabetes will expand from $6.6b in 2013 to an estimated $13.6b by 2023.
  • From 2000-2015 diabetes costs in the U.S. nearly doubled, from $12.05 to $23.35 million.
  • The number of adults living with diabetes has almost quadrupled since 1980.
  • Diabetes is one of the leading causes of death in the world, and in 2012, was the direct cause of 1.5 million deaths.

Cell Transplantation Program For Type 1 Diabetes

  • Funded by and developed in partnership with the JDRF
  • Diabetes Allotransplant Experiments in Non-Human Primates (NHP) are On-Going
  • Identifying the optimal β-stem cell partner for clinical studies

ViBrin™ Treatment of Diabetic Foot Ulcers & Adhesions

Diabetic Foot Ulcer (DFU) Market Scope

  • Between 1.0 – 3.5 million diabetic patients in the United States have a history of foot ulceration

Adhesions Market Scope

  • Demand for adhesion barriers surgeries poised to grow at a CAGR of 9.2% between 2016 and 2024
  • Estimated global market of greater than US$ $USD2.7 Billion by 2020
  • North America market is expected to be US$ 1.6 Billion during 2016 to 2026

Non-Cellular Program Addresses Two Conditions

TREATMENT OF DIABETIC FOOT ULCERS DFUs
are a significant financial burden to health care systems and significantly impact the Quality of Life indices for patients and their families

PREVENTION OF POST-PERITONEAL SURGERY ADHESIONS
An unmet medical need with more than 10 million patients at risk in the US and 25 million patients globally

NEWS & EVENTS

Publications

Preliminary Studies of the Impact of CXCL12 on the Foreign Body Reaction to Pancreatic Islets Microencapsulated in Alginate in Nonhuman Primates

We previously demonstrated that the incorporation of the chemokine CXCL12 into alginate microbeads supported long-term survival of microencapsulated auto-, allo-, and xenogeneic islets in murine models of diabetes without systemic immune suppression. The purpose of this study was to test whether CXCL12 could abrogate foreign body responses (FBRs)...

Long-term Survival of Transplanted Allogeneic Cells Engineered to Express a T Cell Chemorepellent

Alloantigen specific T cells have been shown to be required for allograft rejection. The chemokine, stromal cell derived factor-1 (SDF-1) at high concentration, has been shown to act as a T-cell chemorepellent and abrogate T-cell infiltration into a site of antigen challenge in vivo via a mechanism termed fugetaxis or chemorepulsion. We postulated that this mechanism could be exploited therapeutically and that allogeneic cells engineered to express a chemorepellent protein would not be rejected...

Events

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