Inflammation-Targeting Technology

(ALV-107)

Immune System

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

Immune System

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

Our Inflammation-Targeted Technology is pioneering a novel platform for treating chronic and acute inflammatory disorders. Our platform, the proprietary Alivio Inflammation-Targeting Technology, is designed to preferentially adhere to inflamed tissue, then titrate the level of immune-modulating drugs based on the local levels of inflammation.

  • 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 Alivio Inflammation-Targeting Technology platform has the potential to produce important new medicines in the inflammatory disease space with a superior safety profile
  • 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 MIT and the Brigham & Women’s Hospital of Harvard Medical School
    • The Alivio Inflammation-Targeting Technology platform is designed to help drugs specifically target inflamed tissue and release the drug based on the severity of inflammation
    • The unique properties of our technology can potentially enable current approved drugs to be used in existing as well as new indications with a much superior safety profile and at optimal doses to improve the 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
    • Our Inflammation-Targeted Technology has broad worldwide intellectual property coverage, including exclusive rights to three issued patents and several patent applications on composition of matter, novel formulations and methods
  • 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 that agents that seek to dampen inflammation locally can have substantial side effects and toxicity. Our Inflammation-Targeting Technology is a new approach to addressing this challenge in inflammatory disorders.


Targeting Inflammation