Wheeler Bio, a U.S.-based contract development and biomanufacturing organization (CDMO), has announced a strategic partnership with MindImmune Therapeutics to advance MITI-101, a first-in-class monoclonal antibody targeting neuroinflammation in Alzheimer's disease. The collaboration will leverage Wheeler Bio's specialized ModularCMC platform to support the development and manufacturing of this novel therapeutic approach.
Novel Mechanism Targets Neuroinflammation
MITI-101 represents a groundbreaking strategy in Alzheimer's treatment, designed to block CD11c+ immune cell recruitment from the blood into the brain and prevent their pathologic effects. This first-in-class approach specifically targets the trafficking of peripheral immune cells into the brain, addressing what researchers believe is a key driver of neuroinflammation underlying Alzheimer's and other neurodegenerative disorders.
"MITI-101 represents a first-in-class strategy to stop harmful innate immune cells from driving brain inflammation in Alzheimer's and other neurodegenerative diseases," said Stevin Zorn, President and CEO of MindImmune Therapeutics. "By blocking the infiltration of innate immune cells into the brain, MITI-101 offers a new way to target neuroinflammation — and partnering with Wheeler Bio enables us to advance this groundbreaking science into the clinic with urgency, bringing new hope to patients and families facing these devastating illnesses."
Comprehensive Manufacturing Support
Under the partnership agreement, Wheeler Bio will provide integrated process development and cGMP drug substance manufacturing services through its ModularCMC platform, which specializes in antibody-based modalities. The platform is designed to streamline the path from discovery to clinical study initiation with maximum speed, agility and scalability while maintaining scientific rigor.
Wheeler Bio's scientific team brings aggregate industry experience working on over 1,400 unique molecules, positioning the company as what it describes as a "High-Science/High-Touch biologics CDMO." The ModularCMC platform aims to accelerate the translation from drug discovery to clinical manufacturing through systematic work packages, ultimately resulting in cGMP product supported by a comprehensive Common Technical Document (CTD) Module 3 for Investigational New Drug Applications (INDs).
Strategic Partnership Benefits
The collaboration builds on MindImmune's previous work with Alloy Therapeutics during the discovery phase. Patrick Lucy, President & CEO of Wheeler Bio, highlighted the strategic advantages of this partnership: "We are thrilled to establish this partnership with MindImmune to advance this promising therapeutic focused on a disease where there is significant unmet medical need. MindImmune previously worked with Alloy Therapeutics in the discovery phase and their selection of Wheeler to support their CMC efforts will enable them to take advantage of the significant economic incentives provided by the Wheeler-Alloy partnership."
Company Backgrounds
MindImmune Therapeutics is a preclinical-stage, venture-backed company with offices at the University of Rhode Island, focused on neuroinflammation as a means of addressing neurodegenerative disease. The company's lead program, MITI-101, seeks to inhibit deleterious immune cell recruitment from the blood into the brain in response to pathology in patients with Alzheimer's and other neurodegenerative diseases, potentially representing a fundamental therapeutic breakthrough for the field.
Wheeler Bio positions itself as a contract development and manufacturing pioneer, with its ModularCMC platform enabling rapid translation of antibody-based therapeutics from discovery to clinical studies while ensuring scalability for advanced development and commercialization. The company's mission focuses on accelerating the translation of drug discoveries into clinical impact for partners and the patients they serve.
