Wheeler Bio and MindImmune Therapeutics Sign CDMO Partnership Agreement to Support MindImmune's Lead Alzheimer's Prevention Program, MITI-101

OKLAHOMA CITY, Sept. 17, 2025 /PRNewswire/ -- Wheeler Bio, a U.S.-based contract development and biomanufacturing organization (CDMO), today announced it has entered into an agreement with MindImmune Therapeutics, a biopharmaceutical company focused on neuroinflammation and Alzheimer's disease. Under the agreement, Wheeler Bio will provide integrated process development and cGMP drug substance manufacturing services via its ModularCMC™ platform specializing in antibody-based modalities to support the advancement of the MITI-101 program, MindImmune's lead monoclonal antibody (mAb) program under development for the treatment of Alzheimer's disease.

Wheeler's ModularCMC platform is designed to streamline the path from discovery to clinical study initiation

MITI-101 is designed to block CD11c+ immune cell recruitment from the blood into the brain and to prevent their pathologic effects in Alzheimer's disease. The mAb is a first-in-class approach targeting the trafficking of peripheral immune cells into the brain, a key driver of neuroinflammation believed to underlie Alzheimer's and other neurodegenerative disorders.

As a High-Science/High-Touch biologics CDMO, the Wheeler Bio scientific team is deeply talented with aggregate industry experience that includes working on over 1,400 unique molecules. Wheeler's ModularCMC platform is designed to streamline the path from discovery to clinical study initiation, with maximum speed, agility and scalability while offering a High-Touch approach based on timely transparency, scientific rigor and a true partnering mindset. 

"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," said Patrick Lucy, President & CEO of Wheeler Bio. "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."

"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. 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," said Stevin Zorn, President and CEO of Mindimmune Therapeutics, Inc.

About MindImmune Therapeutics

MindImmune Therapeutics is a preclinical-stage, venture-backed company with offices at the University of Rhode Island, that is focused on neuroinflammation as 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. This could represent a fundamental therapeutics breakthrough for the field. 

About Wheeler Bio

Wheeler Bio is a contract development and manufacturing pioneer who has established the ModularCMC™ platform that enables the rapid translation of antibody-based therapeutics from discovery to clinical studies while ensuring scalability in support of advanced development and commercialization. ModularCMC streamlines the path between drug discovery and clinical manufacturing through well-defined systematic work packages ultimately resulting in cGMP product supported by a comprehensive Common Technical Document (CTD) Module 3 for Investigational New Drug Applications (INDs). Wheeler's High Science/High Touch approach combines cutting edge development and cGMP manufacturing technologies with a deeply experienced scientific team committed to timeline transparency, scientific rigor and a true partnering mindset. Wheeler Bio's mission is to accelerate the translation of drug discoveries into clinical impact for our partners and the patients they seek to serve. 

For Further Information: 

Wheeler Bio, Inc. 

Contact: jpolston@wheelerbio.com 

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SOURCE Wheeler Bio, Inc.