Neuraly and Enigma Biomedical USA Sign Licensing Agreement for PMI04

KNOXVILLE, Tenn. — On January 16, 2025, Neuraly Inc. (Neuraly), a subsidiary of D&D Pharmatech Inc., announced a significant partnership with Enigma Biomedical USA, Inc. (Enigma). This partnership involves a research license and commercialization option agreement for PMI04, a new PET (Positron Emission Tomography) imaging biomarker focused on neuroinflammation, developed by Neuraly.

Under this agreement, Enigma has obtained an exclusive research license for PMI04. They also have the option to negotiate commercialization rights based on the results of their research. PMI04 is designed to selectively bind to CSF-1R (Colony Stimulating Factor 1 Receptor), which is found in activated microglia. This binding capability allows for better visualization of the pathological activities related to microglia, the primary contributors to neuroinflammatory responses. This could greatly help in diagnosing various neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and multiple sclerosis.

Advancements in Neuroimaging

Enigma intends to concentrate its development efforts on assessing neurodegenerative diseases using PMI04. Previously, neuroimaging methods primarily targeted TSPO (Translocator Protein) but often faced challenges due to limited specificity. As a result, interpretation and quantitative assessment were complicated. In contrast, PMI04's focus on CSF-1R provides a more direct correlation with microglial activity, allowing for improved quantification and the early detection of inflammation related to neurodegenerative conditions.

Should the research yield successful results, Neuraly and Enigma will establish a commercialization license agreement, enabling Enigma to have exclusive rights for the development and commercialization of PMI04. Neuraly will benefit from upfront payments and potential milestone payments tied to the progress of development and sales royalties upon commercialization.

Statements from Company Leaders

Seulki Lee, CEO of Neuraly, expressed optimism regarding the partnership, stating, “We hope this collaboration will significantly advance the diagnosis and treatment of neurodegenerative diseases. Our goal is to ensure a swift commercialization of PMI04 through close cooperation with Enigma.”

Rick Hiatt, President and CEO of Enigma, shared his excitement about the partnership as well: “Being selected as a development partner by Neuraly is a great honor. We plan to build on our previous achievements with leading neuroimaging biomarkers such as MK-6240 and NAV-4694. We are confident that the unique properties of Neuraly’s CSF-1R PET imaging biomarker will be crucial in the development of current and future therapies for neurodegenerative diseases. Our goal is to make this innovative imaging agent widely available to the scientific community.”

About the Companies

Enigma Biomedical USA, Inc. aims to become the leading provider of imaging biomarkers for neurological disorders, along with the supporting technology to enhance the development and approval of effective therapies for neurodegenerative diseases. Their past contributions to the field include providing state-of-the-art Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, both of which have seen successful acquisition for further development.

D&D Pharmatech Inc., which focuses on developing GLP-1 receptor agonists, has partnered with Johns Hopkins University to create imaging biomarkers related to neurodegenerative conditions. Neuraly, its wholly-owned subsidiary, specializes in clinical development for various diseases and has cleared several Investigational New Drug applications, including a recent clinical development for Parkinson's disease.

research, biomarker, partnership