OKLAHOMA CITY, Sept. 17, 2025 – Wheeler Bio, Inc., a U.S.-based contract development and manufacturing organization (CDMO), announced today a strategic partnership with MindImmune Therapeutics, Inc., a biopharmaceutical company pioneering therapies in neuroinflammation. The collaboration will support the advancement of MITI-101, MindImmune’s lead monoclonal antibody (mAb) program targeting immune cell infiltration in Alzheimer’s disease.
The agreement grants MindImmune access to Wheeler’s ModularCMC™ platform, a proprietary system designed to accelerate the transition from discovery to clinical study initiation, while ensuring scalability, transparency, and scientific rigor. This alliance highlights the growing role of specialized CDMOs in enabling biotech companies to bring novel therapies into the clinic more efficiently.
Science Significance
MITI-101 represents a first-in-class approach that blocks CD11c+ immune cell recruitment from the blood into the brain, addressing a key driver of neuroinflammation in Alzheimer’s disease. Unlike current treatments focused on amyloid or tau pathology, MITI-101 directly targets the inflammatory cascade believed to underlie neurodegeneration. If successful, this approach could redefine therapeutic strategies for Alzheimer’s and related neurodegenerative disorders.
Regulatory Significance
The partnership leverages Wheeler’s cGMP-ready ModularCMC™ platform, which delivers drug substance manufacturing supported by a full Common Technical Document (CTD) Module 3 package for IND submissions. This regulatory-ready framework ensures MindImmune can pursue accelerated pathways toward first-in-human studies, while meeting the FDA’s stringent standards for biologics development.
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Business Significance
For Wheeler Bio, this deal further validates its position as a high-science/high-touch CDMO capable of supporting innovative biotech firms at critical preclinical-to-clinic inflection points. For MindImmune, the partnership offers both operational efficiency and economic incentives through Wheeler’s prior collaboration with Alloy Therapeutics, enabling cost-effective advancement of MITI-101. This transaction underscores the growing ecosystem of CDMOs empowering early-stage biotech innovation in Alzheimer’s research.
Patients’ Significance
Alzheimer’s disease continues to impose a devastating burden, with limited treatment options offering only modest benefits. By targeting neuroinflammation, MITI-101 offers patients and families a new form of hope—the possibility of preserving neuronal health, slowing disease progression, and maintaining dignity in the face of a debilitating illness. If proven safe and effective, this therapy could address a critical unmet need and improve the quality of life for millions worldwide.
Policy Significance
The Wheeler–MindImmune collaboration reflects broader policy priorities encouraging biotech innovation in neurodegeneration, a therapeutic area receiving increasing global attention. With Alzheimer’s costs projected to overwhelm healthcare systems, novel strategies that delay or prevent disease progression align with public health and sustainability goals. Policymakers are likely to watch closely as MITI-101 advances, potentially shaping frameworks for reimbursement, access, and early adoption of neuroinflammation-targeting biologics.
Transaction Highlights
Under the terms of the agreement, Wheeler Bio will provide integrated process development and cGMP drug substance manufacturing services to MindImmune via its ModularCMC™ platform, specializing in antibody-based modalities. MindImmune’s MITI-101, a monoclonal antibody designed to block CD11c+ immune cell recruitment into the brain, represents a novel therapeutic strategy to halt harmful immune cell infiltration, a major driver of neuroinflammation in Alzheimer’s disease. The Wheeler scientific team, with extensive expertise across more than 1,400 unique molecules, will ensure that MITI-101 progresses with maximum speed, agility, and scalability from preclinical discovery toward first-in-human clinical studies. MindImmune previously collaborated with Alloy Therapeutics during the discovery phase, and this new partnership with Wheeler Bio enables the company to leverage significant economic and operational advantages from the Alloy–Wheeler alliance. Both companies expressed commitment to bringing MITI-101 to patients urgently, highlighting the shared vision of translating groundbreaking science into meaningful clinical impact.
Source: Wheeler Bio, Inc. Press Release
