Inflammation-Targeting Technology

(ALV-107)

Immune System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
Inflammation-Targeting Technology
Inflammatory Bowel Disease, Interstitial Cystitis/Bladder Pain Syndrome (IC/IBS)
Alivio
(ALV-107)

Immune System

Inflammation-Targeting Technology
INDICATION(S):Inflammatory Bowel Disease, Interstitial Cystitis/Bladder Pain Syndrome (IC/IBS)
NAME:Alivio (ALV-107)
STAGE:Preclinical
Inflammation-Targeting Technology

Our affiliate Alivio is pioneering targeted disease immunomodulation as a novel strategy to treat a range of acute and chronic inflammatory disorders. Targeted disease immunomodulation involves tuning the immune system exclusively at the site of disease in the body, with minimal impact on the rest of the immune system. This long sought-after approach has the potential to treat a range of chronic and acute inflammatory disorders, including ones that would otherwise be difficult to treat. Our proprietary inflammation-targeted technology is the first known engineered technology to reproducibly target immunomodulatory compounds to inflamed tissue and release them in response to heightened inflammation, which can lead to dramatic improvements in treatment efficacy with major reductions in systemic effects.

  • Patient Need & Market Potential
    • Existing therapies for inflammatory diseases are limited by toxicity, side effects, or lack of efficacy, primarily due to an imbalance between drug exposure in inflamed and healthy tissues
    • There is a substantial opportunity for targeted therapies that selectively reduce disease associated inflammation without leading to broad immunosuppression or other systemic effects.
    • Our inflammation-targeting technology platform has the potential to produce important new medicines in the inflammatory disease space with a superior safety profile.
    • Results in preclinical models suggest the Alivio technology could be applied to diseases such as IBD, inflammatory arthritis, organ transplantation, and interstitial cystitis. These diseases collectively impact tens of millions of patients in the US alone and have limited treatment options.
  • Our Approach to Solving the Problem
    • Our approach to developing targeted therapies for treating inflammatory disease is based on an innovative and proprietary new material based on work started at the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital (BWH)
    • Our inflammation-targeted technology platform is designed to help immunomodulatory compounds specifically target inflamed tissue and become bioavailable based on signals from the diseased tissue on the severity of the local inflammation.
    • The innovative properties of our technology may enable currently approved drugs to be used in existing as well as new indications with a better safety profile and improved efficacy. The technology also has the potential to allow drugs with challenging pharmacokinetics or safety profiles to come to market when they would not otherwise have done so.
  • Intellectual Property
    • We have broad intellectual property coverage worldwide, currently owning or having exclusive rights to 14 patent applications in 7 families of patent filings, two of which patent applications were recently allowed in the U.S. in 2018
    • Our IP estate covers composition of matter, novel formulations and methods of using nanostructured gels for the delivery of therapeutic agents
  • Team
    • Our team has strong backgrounds in drug delivery, biomaterials, animal model development, and analytical chemistry 
    • Key advisors include inventor Dr. Jeff Karp, Associate Professor at Brigham and Women's Hospital, Harvard Medical School, Principal Faculty at the Harvard Stem Cell Institute and Principal Investigator at Karp Lab; Dr. Robert Langer, Non-Executive Director at PureTech Health known for his groundbreaking discoveries in the fields of materials chemistry, controlled drug delivery, and tissue engineering; Dr. Michael Brenner, Chief of the Division of Rheumatology, Immunology, and Allergy at the Brigham and Women’s Hospital; Dr. Ulrich H. von Andrian, the Mallinckrodt Professor of Immunopathology at Harvard Medical School;  Dr. Ralph Weissleder, Professor of Radiology and Professor of Systems Biology at Harvard Medical School, Director of the Center for Systems Biology at Massachusetts General Hospital (MGH), and Attending Clinician (Interventional Radiology) at MGH
  • Milestones Achieved
    • Our Alivio Inflammation-Targeting Technology was exclusively licensed in 2016 from the lab of Jeff Karp, PhD, Associate Professor at Brigham and Women's Hospital (BWH), Harvard Medical School and Robert Langer, ScD, Institute Professor, MIT. In March of 2017, the Bill & Melinda Gates Foundation awarded a $1.2 million grant to Professor Jeff Karp’s Lab at BWH to support additional research on the technology
    • The novel properties of our Alivio Inflammation-Targeting Technology have been published twice in Science Translational Medicine. The published data showed improvements in safety, efficacy, and dosing by delivering drugs using our proprietary Inflammation-Targeting Technology platform in IBD and transplant rejection animal models [See publications below]
    • Data were presented at the 2017 Drug Discovery and Therapy World Congress for lead product candidate, ALV-107, showing durable pain control throughout a 24-hour study period, lasting at least 12 times longer than lidocaine at a comparable dose (ALV-107 16 mg/kg, conventional lidocaine 16 mg/kg), in a validated preclinical model for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) 
    • Multiple active pharmaceutical ingredients (APIs) were shown to be successfully incorporated into the Alivio Inflammation-Targeting Technology at clinically relevant levels. The APIs covered a range of solubilities, molecular weights and potential dosage forms. These findings confirm and expand the range of new therapeutic opportunities
  • Expected Milestones and Timing
    • We anticipate that our lead product candidate, ALV-107, will enter clinical trials in 2019

There are numerous health conditions caused by chronic and acute inflammation. Despite the magnitude of the unmet need and the substantial progress in basic research, few truly novel drugs have come to market in the last decade. A major complicating factor has been that the pathways that modulate inflammation act broadly, so agents that seek to dampen inflammation locally can have substantial side effects and toxicity. Targeted disease immunomodulation using our inflammation-targeting technology is a new approach to address this challenge in inflammatory disorders.


Targeting Inflammation