Agreement Between Neuraly and Enigma Biomedical USA on PET Imaging Biomarker PMI04
On January 16, 2025, Neuraly Inc., a wholly owned subsidiary of D&D Pharmatech Inc., and Enigma Biomedical USA, Inc. revealed that they have signed a research license and commercialization option agreement for PMI04, a PET imaging biomarker for neuroinflammation developed by Neuraly.
This biomarker, developed by Neuraly, targets neuroinflammation by selectively binding to the CSF-1R (Colony Stimulating Factor 1 Receptor), which is expressed on activated microglia. Microglia are key contributors to the brain’s immune response and play a critical role in neuroinflammatory processes. By using PMI04, researchers can visualize the pathological activity of microglia, which is important for diagnosing and understanding the progression of neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis.
Enigma will have exclusive rights to research PMI04, with the option to negotiate commercialization rights based on the results of the research. The company plans to focus its efforts on leveraging PMI04 for evaluating neurodegenerative diseases. The agreement marks a significant step in advancing neuroimaging technology that could enhance early detection, monitoring, and understanding of diseases associated with neuroinflammation.
Currently, PET imaging is often used to study neuroinflammation, with the most common target being TSPO (Translocator Protein). However, TSPO imaging suffers from limited specificity, which makes it challenging to interpret results and obtain accurate quantitative assessments. In comparison, PMI04 specifically binds to CSF-1R on activated microglia, providing a direct link to microglial activation, proliferation, and survival. This specific binding ability makes PMI04 a next-generation PET imaging biomarker that could improve the quantification, early detection, and pathological analysis of inflammation-related neurodegenerative diseases. Ultimately, it has the potential to advance the development of therapeutics by providing more precise and reliable data for clinical research.
The agreement includes provisions for future commercialization. If the research yields positive results, Enigma will have the option to enter into a commercialization license agreement, granting them exclusive rights to develop and market PMI04. In return, Neuraly will receive an upfront payment, milestone payments tied to the progress of development and commercialization, and royalties on future sales once PMI04 reaches the market.
Seulki Lee, CEO of Neuraly, expressed optimism about the partnership, saying, “We hope this partnership will represent a significant step forward in providing alternatives for the diagnosis and treatment of neurodegenerative diseases. We will do our utmost to ensure that PMI04 is commercialized swiftly through close collaboration with Enigma.” This statement underscores Neuraly’s commitment to advancing neurodegenerative disease research and providing new tools to improve patient outcomes.
Rick Hiatt, President and CEO of Enigma, also voiced his enthusiasm for the collaboration, stating, “We are delighted to have been selected as a development partner by Neuraly. We will build on demonstrated successes with the best-in-class neuroimaging biomarkers MK-6240 (Cerveau Technologies) and NAV-4694 (Meilleur Technologies). We believe the Neuraly CSF-1R PET imaging biomarker has unique properties and will prove useful in developing current and future therapeutics for neurodegenerative diseases. Our commitment is to expand the availability of this novel investigational imaging agent to the broader scientific community.” This partnership highlights Enigma’s strategic focus on advancing cutting-edge neuroimaging technologies to support the development of new therapies for neurological conditions.
Enigma Biomedical USA, Inc. is a leading provider of imaging biomarkers for neurological pathologies and related technologies. The company aims to accelerate the development, approval, and adoption of effective therapies for neurodegenerative diseases. Enigma’s biomarkers, including MK-6240 and NAV-4694, are used by pharmaceutical and academic researchers to enable the development of disease-modifying therapies with high precision. Enigma’s commitment to advancing neuroimaging technology is further demonstrated by its recent partnership with AbbVie to explore novel Tau PET imaging biomarkers.
D&D Pharmatech Inc., listed on the KOSDAQ in Korea, specializes in the development of GLP-1 receptor agonists and has a long-term partnership with Johns Hopkins University School of Medicine to develop imaging biomarkers for neurodegenerative diseases. The company is also advancing clinical trials for GLP-1 receptor agonists in various indications, including Parkinson’s disease, with the successful completion of a Phase 2 trial for its weekly injectable candidate, pegsebrenatide (NLY01).
Neuraly Inc., D&D’s wholly-owned subsidiary based in Gaithersburg, Maryland, focuses Agreement on clinical development and IND-enabling studies for D&D’s programs targeting neurodegenerative, metabolic, and fibrotic diseases. Neuraly has conducted five clinical trials to date, including four completed studies and an ongoing Phase 2 trial of DD01 for metabolic dysfunction-associated steatohepatitis (MASH).
This new agreement between Neuraly and Enigma highlights the growing importance of advanced imaging biomarkers in the study of neurodegenerative diseases. By Agreement focusing on PMI04, both companies aim to pave the way for better diagnostic tools and more targeted therapies for conditions that have long posed challenges in the medical community.
