ICaPath is an emerging biotechnology company headquartered at Johns Hopkins Technology Ventures (JHTV) in Baltimore, MD, leveraging this premier academic ecosystem to advance a disruptive nanoparticle-based drug delivery platform. Our core therapeutic asset utilizes biocompatible PLGA nanoparticles to encapsulate highly potent cytokines, small molecules, and genetic constructs. Paired with our proprietary immune-surveillance diagnostic capabilities, this effective delivery vehicle creates a precision pipeline that empowers clinicians to safely deploy and dynamically monitor previously inaccessible immunotherapies.
The commercial centerpiece of our platform is the successful encapsulation of our proprietary recombinant human IL-12 (rHU IL-12), universally recognized as the gold standard cytokine for driving strong systemic immune responses against pleomorphic solid tumors. Historically, the clinical development of naked IL-12 has been derailed by severe, dose-limiting systemic toxicities. ICaPath’s proprietary formulation resolves this decades-old bottleneck by fundamentally altering the drug’s pharmacokinetic profile, achieving robust therapeutic efficacy at doses logarithmically lower than previous clinical minimums.
By ensuring the sustained elution of IL-12 exclusively within the extravascular interstitial space, ICaPath safely orchestrates a significant systemic immune response in metastatic diseases. This breakthrough ability to eliminate toxic systemic circulation while preserving profound anti-tumor efficacy establishes a highly de-risked pathway toward our upcoming IND submission. By safely unlocking systemic immune responses beyond limited target therapies, ICaPath offers a highly scalable therapeutic asset positioned to capture substantial value across the multi-billion-dollar oncology and advanced drug delivery markets.
Highlights
Since inception in 2021, the Company has achieved:
Developed and validated in pre-clinical studies three (3) standalone core assets to our novel immunotherapy solution: a nano-delivery platform, a surveillance diagnostic, and a low dose IL-12 therapeutic (LD IL-12).
Received repeated FDA endorsement to execute a solid CMC strategy to support a FIH clinical trial for Melanoma, Soft Tissue Sarcoma, Renal Cell Carcinoma, and Pediatric Osteosarcoma.
Secured GMP manufacturing for clinical grade drug product while building scale-up capabilities to support additional clinical applications.
Competitive Advantage
ICaPath is the only company delivering PLGA nanoparticle-encapsulated cytokines for systemic delivery in cancer immunotherapy. Encapsulating IL-12 with PLGA nanoparticles allows our therapeutic to be delivered in a way that maximizes its efficacy and eliminates the inherent IL-12 toxicity. This is accomplished through repeated low-dose tissue deposition, supported by a precise slow-release profile achieved through our proprietary nanoparticle formulation with superior IL-12 elution over time.
Our immunodiagnostic platform can support most immunotherapy programs by monitoring their ability to deliver the right dose, to the right place, over the right amount of time, allowing a truly personalized medicine approach guided by precise biomarkers. Our PLGA nanoparticles enable slow release, providing sustained progressive stimulation over time through periodic and precisely titrated dosing, resulting in an effective systemic immune response against primary and metastatic cancer cells in solid tumors.
Management
Deep experience in biotechnology management, operations, capital raising, and research and development.
Brock Lindsey – Founder and Chairman of the Board
Paulo Fontes – Co-Founder and Chief Medical Officer
Steve Norch – President, former CEO of Biomath
Rob Finizio – Vice Chairman of the Board, former Co-Founder and CEO of CareFusion and TherapeuticsMD, Chairman Emeritus of BioFlorida, and current Managing Director of MintPharma Capital.
