Welcome to ICaPath /EYE-SEE-A-PATH/
Pioneering Therapies for the most important people in our lives
Pioneering Therapies for the most important people in our lives
Pioneering Therapies for the most important people in our lives
- Non-specific Immunotherapies
- Interleukins (e.g., IL-12), Interferons, Immunomodulators (IMiDs)
- Monoclonal antibodies and immune checkpoint inhibitors
- Naked mAb, Conjugated mAb, Biospecific mAb
- PD-1, PD-L1, CTL-4 inhibitor, TF inhibitor
- Oncolytic virus therapy
- T-cell therapy
- TIL, Engineered TCR, CART-cell, NK-cell therapy
- Cancer vaccines
- Cervarix, Gardasil, HBV, Sipuleucel-T, T-VEC, BCG
- Non-specific Immunotherapies
- Interleukins (e.g., IL-12), Interferons, Immunomodulators (IMiDs)
- Monoclonal antibodies and immune checkpoint inhibitors
- Naked mAb, Conjugated mAb, Biospecific mAb
- PD-1, PD-L1, CTL-4 inhibitor, TF inhibitor
- Oncolytic virus therapy
- T-cell therapy
- TIL, Engineered TCR, CART-cell, NK-cell therapy
- Cancer vaccines
- Cervarix, Gardasil, HBV, Sipuleucel-T, T-VEC, BCG
PLGA nanoparticle move from intra to extra vascular (EV) space
PLGA nanoparticle releases rHu-IL12 into EV space
rHU-IL12 activates T and NK cells to recognize/destroy tumor
PLGA nanoparticle move from intra to extra vascular (EV) space
PLGA nanoparticle releases rHu-IL12 into EV space
rHU-IL12 activates T and NK cells to recognize/destroy tumor
INNOVATION
What Sets ICaPath apart from the Rest
What Sets ICaPath apart from the Rest
What Sets ICaPath apart from the Rest
Systemic delivery of proprietary PLGA nanoparticle platform has best-in-class elution profiles with a fully biodegradable construct
Leading asset PLGA nanoparticle delivering rHuIL-12:
- Precision delivery of specific doses of IL-12 over a specific time
- Only non liposome compound to be approved for systemic delivery, allowing effective treatment for metastatic cancer
- Reliable PLGA encapsulated delivering system to avoid IL-12 early intravascular activation and degradation prior to achieve the tissue targets
- Broad size range for PLGA nanoparticles provides unique opportunities to induce desired biological effects (intracellular and intercellular)
Proprietary immunodiagnostics platform precisely specify and quantify the patient’s immune response during treatment, & subsequent immunosurveillance
Systemic delivery of proprietary PLGA nanoparticle platform has best-in-class elution profiles with a fully biodegradable construct
Leading asset PLGA nanoparticle delivering rHuIL-12:
- Precision delivery of specific doses of IL-12 over a specific time
- Only non liposome compound to be approved for systemic delivery, allowing effective treatment for metastatic cancer
- Reliable PLGA encapsulated delivering system to avoid IL-12 early intravascular activation and degradation prior to achieve the tissue targets
- Broad size range for PLGA nanoparticles provides unique opportunities to induce desired biological effects (intracellular and intercellular)
Proprietary immunodiagnostics platform precisely specify and quantify the patient’s immune response during treatment, & subsequent immunosurveillance
RESEARCH & TECHNOLOGY
Unique Intellectual Property and Portfolio
Unique Intellectual Property and Portfolio
Unique Intellectual Property and Portfolio
- Provisional patent filed November 2019
- PCT filed December 2020 (over 60 claims)
- International PCT filed Feb 2021 WSGR
- FTO completed by WSGR completed Jan 2021
- US Track One application filed with the USPTO 6.2.22
- International Coverage filed as well WSGR
- Provisional patent filed November 2019
- PCT filed December 2020 (over 60 claims)
- International PCT filed Feb 2021 WSGR
- FTO completed by WSGR completed Jan 2021
- US Track One application filed with the USPTO 6.2.22
- International Coverage filed as well WSGR
Introduction to our projects
rHul L-12
- IL-12 is a strong stimulator of both innate and adaptive immunity via T-cells and natural killer cells that has shown great efficacy against pleomorphic neoplastic diseases (e.g., osteosarcomas)
- IL-12 has shown major toxicity and undesirable adverse events when utilized systemically and unencapsulated in initially much higher doses
- IL-12 broad immunostimulation allows the human immune system to react, adapt, and mount effective cell and antibody mediated cytotoxic responses against fast growing neoplastic cells while blocking the development of cancer-driven angiogenesis
PLGA
- Proprietary PLGA nanoparticle technology capable of providing efficient delivery options for companies working with drugs and biologics, including genetic constructs currently being utilized in breakthrough vaccines
- The final product of PLGA encapsulated IL-12 having a range of particle size from 100nm-1000nm, zeta potentials less than -30 mV, encapsulation efficiency between 20-40%, and with an average elution of 1ng of IL-12/1 gram of particles/day.
lL-12 + PLGA
- The systemic use of IL-12 has major and potentially lethal toxicity (Lee et al., 1998).
- systemic flu-like symptoms (fever, chills, fatigue, arthromyalgia, headache)
- bone marrow toxicity leading to important hematologic complications (neutropenia and thrombocytopenia)
- hepatotoxicity leading to direct hepatic dysfunction manifested mainly and dose-dependently by significant hepatocellular necrosis
- systemic effects characterized by undesirable inflammation in their mucus membranes (e.g., oral mucositis, stomatitis, or colitis).
Historically, free non-encapsulated IL-12 was developed and utilized under a MTD paradigm that was common decades ago. However, this approach led to one of two extreme immune pathways, with potentially severe and even fatal outcomes. The immune consequences of high dose therapy from prior development programs were:
- Overstimulation of the immune system leading to systemic inflammatory response syndrome (SIRS), characterized by tachycardia, tachypnea, hypo/hyperthermia, and leukocytosis/leukopenia.
- Immune exhaustion, leading to a further immunocompromised state
Diagnostic
- Fluorescently labeling both surface and intracellular components of isolated human leukocytes allows the real-time analysis of immune status using flow cytometry. methods include Live/Dead staining, blocking of Fc receptors, epitope-specific cell-surface staining, cell fixation and permeabilization, and epitope-specific intracellular staining; staining is via fluorescently conjugated antibodies and amine reactive dyes. Methods described enable downstream analysis for the identification of live cells that are subsequently categorized by the presence or absence of the cellular epitopes and expression markers CD45RA, CD45RO, CD56, CD11b, cd14, cd15, Lox-1, HLA-DR, CD3, CD4, CD8, CD25, Fox-P3, CD127, CTLA-4, Pd-L1, PD-1, and Tim-3.
rHul L-12
- IL-12 is a strong stimulator of both innate and adaptive immunity via T-cells and natural killer cells that has shown great efficacy against pleomorphic neoplastic diseases (e.g., osteosarcomas)
- IL-12 has shown major toxicity and undesirable adverse events when utilized systemically and unencapsulated in initially much higher doses
- IL-12 broad immunostimulation allows the human immune system to react, adapt, and mount effective cell and antibody mediated cytotoxic responses against fast growing neoplastic cells while blocking the development of cancer-driven angiogenesis
PLGA
- Proprietary PLGA nanoparticle technology capable of providing efficient delivery options for companies working with drugs and biologics, including genetic constructs currently being utilized in breakthrough vaccines
- The final product of PLGA encapsulated IL-12 having a range of particle size from 100nm-1000nm, zeta potentials less than -30 mV, encapsulation efficiency between 20-40%, and with an average elution of 1ng of IL-12/1 gram of particles/day.
lL-12 + PLGA
- The systemic use of IL-12 has major and potentially lethal toxicity (Lee et al., 1998).
- systemic flu-like symptoms (fever, chills, fatigue, arthromyalgia, headache)
- bone marrow toxicity leading to important hematologic complications (neutropenia and thrombocytopenia)
- hepatotoxicity leading to direct hepatic dysfunction manifested mainly and dose-dependently by significant hepatocellular necrosis
- systemic effects characterized by undesirable inflammation in their mucus membranes (e.g., oral mucositis, stomatitis, or colitis).
Historically, free non-encapsulated IL-12 was developed and utilized under a MTD paradigm that was common decades ago. However, this approach led to one of two extreme immune pathways, with potentially severe and even fatal outcomes. The immune consequences of high dose therapy from prior development programs were:
- Overstimulation of the immune system leading to systemic inflammatory response syndrome (SIRS), characterized by tachycardia, tachypnea, hypo/hyperthermia, and leukocytosis/leukopenia.
- Immune exhaustion, leading to a further immunocompromised state
Diagnostic
- Fluorescently labeling both surface and intracellular components of isolated human leukocytes allows the real-time analysis of immune status using flow cytometry. methods include Live/Dead staining, blocking of Fc receptors, epitope-specific cell-surface staining, cell fixation and permeabilization, and epitope-specific intracellular staining; staining is via fluorescently conjugated antibodies and amine reactive dyes. Methods described enable downstream analysis for the identification of live cells that are subsequently categorized by the presence or absence of the cellular epitopes and expression markers CD45RA, CD45RO, CD56, CD11b, cd14, cd15, Lox-1, HLA-DR, CD3, CD4, CD8, CD25, Fox-P3, CD127, CTLA-4, Pd-L1, PD-1, and Tim-3.
PIPELINE
We are developing a broad portfolio of products designed to cure serious diseases in new ways
We are developing a broad portfolio of products designed to cure serious diseases in new ways
We are developing a broad portfolio of products designed to cure serious diseases in new ways
Technology
Preclinical
Clinical
Phase 1
Phase 2
Phase 3
approval
IL12 Protein
PLGA
IL12+PLGA
Diagnostic
Our Current Research
ICaPath is currently manufacturing rHu IL-12 and PLGA nanoparticles under GMP guidelines in 2 world-class CDMOs to support the upcoming phase first in human clinical trial
Dedicated to the improvement of lives
Dedicated to the improvement of lives
Dedicated to the improvement of lives
From our founder
ICaPath has spent over a decade to pioneer the use of prolonged and very low dose IL-12 encapsulated into a new delivery PLGA nanoparticle platform while providing a new diagnostic test to provide continuous immunosurveillance for patients undergoing immunotherapy.
ICaPath has spent over a decade to pioneer the use of prolonged and very low dose IL-12 encapsulated into a new delivery PLGA nanoparticle platform while providing a new diagnostic test to provide continuous immunosurveillance for patients undergoing immunotherapy.
BROCK LINDSEY MD
BROCK LINDSEY MD
Safe delivery, precise and adaptable dosing and assuring efficacy are our main goals.
Our Team
Our Team
ICaPath is made up of members and researchers located across the North Eastern region of the United States. We have assembled a team of the most qualified people to work with us, regardless of location. Our practice locations include some of the nations’ leading healthcare facilities.
Founder & CSO
BROCK LINDSEY MD
BROCK LINDSEY MD
Associate Professor Department of Orthopaedic Surgery John Hopkins University
Medical/Strategic Advisor
PAULO FONTES, MD, FACS
PAULO FONTES, MD, FACS
Chief Scientific/Medical Officer, Eikonoklastes Inc., Cincinnati, OH
Co-Founder & Medical Advisor LyGenesis, Pittsburgh, PA
Co-Founder, VirTech Bio, Natick, MA
Former Professor of Surgery & Deputy Director, McGowan Institute for Regenerative Medicine, School of Medicine, University of Pittsburgh
CHIEF EXECUTIVE OFFICER
Steve Norch
Steve Norch
Former CEO Biomath Solutions
Former CEO EK Norch Inc
CEO Ocius Intelligence
CHIEF OPERATIONS OFFICER
Phil Farabaugh, MBA
Phil Farabaugh, MBA
COO VirTech Bio, Natick, MA
CHIEF FINANCIAL OFFICER
John Kennedy
John Kennedy
Career Investment Banker
Morgan Stanley & Co.
Laidlaw & Co.
Former Chief Financial Officer
SeqLL Inc.
Resource Holdings Inc.
Intercontinental Telecom Corp.
Get in Touch
Get in Touch
We take pride in the work we do, and are always willing to talk about the impact our research will have. For more information, or to discuss collaboration or investments please reach out.
We take pride in the work we do, and are always willing to talk about the impact our research will have. For more information, or to discuss collaboration or investments please reach out.
Send a message
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