Biopharma to refit former Gore building near Del. border for use as manufacturing site

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Clene Inc., a research-stage biopharma company, focusing on treating degenerative neuological disease, completed two lease agreements in Cecil County, MD, that will add manufacturing capacity for CNM-Au8, a gold crystal suspension.

The publicly traded Salt Lake City company is pursuing the use of nanotechnology  (the use of tiny matter) to treat ALS, multiple sclerosis, and Parkinson’s disease. The current focus is on a promising trial for ALS or Lou Gehrig’s Disease.

Endpoints reported the gold crystal nanotechnology could aid in nerve cell survival and communication.

The first of these agreements is a ten-year lease for manufacturing space at 100 Chesapeake Boulevard in Elkton.

The 74,210 square foot building near the Delaware border and formerly occupied by W.L. Gore & Associates will be redeveloped to support Clene’s electrochemical processes for manufacturing CNM-Au8. They will increase its manufacturing capacity in advance of the late-stage 2022 data release from its Phase 3  trial evaluating the technology. Phase 1 of production is to be underway in the first half of 2022.

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Clene also entered into a seven-year lease to further expand its existing manufacturing capacity at its site located at 500 Principio Parkway West, North East, to a total of 32,229 square feet. The expansion enables additional R&D and manufacturing capacity for CNM-Au8 and further positions Clene to address its potential long-term needs in its efforts to treat neurodegenerative diseases.

Rob Etherington, CEO of Clene, stated, “All emerging pharmaceutical companies face the delicate balance of striving to align manufacturing capacity with the rigors of regulatory approvals and ultimately patient needs. As we move towards a readout from our registration trial in patients with ALS, we concluded this was the most appropriate time to undertake this expansion of our manufacturing capabilities.”

Mark Mortenson, chief science officer of Clene, stated, “Completion of these lease agreements could not have been accomplished without the tireless work of our landlord, the Town of Elkton, Cecil County, and the State of Maryland. The foresight, professionalism, and commitment by the leadership teams in the town, the county, and the state were wonderful to experience and are a perfect example of the teamwork that abounds in the State of Maryland.”

Mortenson is active in Cecil County civic affairs and serves as a trustee for Cecil Community College. 

 

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