Neuraly and Enigma Biomedical USA announce a Research License and Commercialization Option Agreement for PET Imaging Biomarker, PMI04

KNOXVILLE, Tenn.--(BUSINESS WIRE)--On January 16, 2025, Neuraly Inc. (Neuraly), a wholly owned subsidiary of D&D Pharmatech Inc., and Enigma Biomedical USA, Inc. (Enigma) announced the signing of a research license and commercialization option agreement for PMI04, a PET (Positron Emission Tomography) imaging biomarker of neuroinflammation developed by Neuraly.

Under the agreement, Enigma acquires an exclusive research license for PMI04, as well as the option to negotiate commercialization rights based on the research results. PMI04 is a PET imaging biomarker that selectively binds to CSF-1R (Colony Stimulating Factor 1 Receptor) expressed in activated microglia. It enables visualization of the pathological activity of microglia, the fundamental contributors to neuroinflammatory responses, aiding in the diagnosis of various neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. Enigma plans to focus its development efforts on utilizing PMI04 for the assessment of neurodegenerative diseases.

Currently, PET imaging targeting TSPO (Translocator Protein) is used in neuro research, but exhibits limited specificity, leading to challenging interpretation and quantitative assessment. In contrast, CSF-1R specifically binds to activated microglia, directly correlating with microglial proliferation and survival. This makes PMI04 a next-generation PET imaging biomarker capable of quantifying assessment, early detection, and pathological analysis of inflammation-related neurodegenerative diseases, which may ultimately benefit the development of therapeutics.

With successful conclusion of the research, a commercialization license agreement will be established between the two companies, granting Enigma exclusive development and commercialization rights for PMI04. Neuraly will receive an upfront payment and milestone payments based on development and commercialization progress, along with sales royalties upon the commercial sales in the future.

Seulki Lee, CEO of Neuraly stated "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."

“We are delighted to have been selected as a development partner by Neuraly,” said Rick Hiatt, President and CEO of Enigma. “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 disease. Our commitment is to expand the availability of this novel investigational imaging agent to the broader scientific community.”

About Enigma Biomedical USA, Inc.

Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. Enigma’s neuroimaging biomarkers provide Pharma and Academic researchers with state-of-the-art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In pursuit of this vision, subsidiaries of Enigma have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. Both tracers have recently been acquired by a third party for further development. Enigma also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers.

About D&D Pharmatech, Inc. and Neuraly Inc.

D&D Pharmatech Inc. (D&D), listed on the KOSDAQ in Korea, specializes in the development of GLP-1 receptor agonists. The company has established a long-term partnership with the Johns Hopkins University School of Medicine to develop imaging biomarkers related to neurodegenerative diseases. Additionally, D&D is conducting clinical trials for GLP-1 candidates in various indications, including a completion of a Phase 2 trial in the U.S. for the weekly injectable GLP-1 receptor agonist pegsebrenatide (NLY01) in Parkinson’s disease patients in 2023.

Neuraly Inc. (Neuraly), D&D's wholly-owned subsidiary located in Gaithersburg, Maryland, USA, specializes in IND-enabling studies and clinical development for D&D’s programs targeting neurodegenerative, metabolic, and fibrotic diseases. Neuraly has successfully cleared multiple INDs and conducted five clinical trials to date, including four completed studies and an ongoing Phase 2 trial of DD01 for metabolic dysfunction-associated steatohepatitis (MASH).