Clene Nanomedicine has quadrupled production capacity to support candidate CNM-Au8, a gold nanocrystal suspension it says could be a gamechanger in the neurodegenerative disease space.

The Utah-based biotech has entered into both a 10 year lease for a manufacturing space located in Elkton, Maryland and a seven year lease to further expand its existing manufacturing capacity nearby. The expanded capabilities will serve to support lead candidate CNM-Au8, currently in Phase II studies for amyotrophic lateral sclerosis (ALS).

“In our existing space in North East, Maryland, we originally had about 21,000 square feet of space and are increasing that space by 11,000 square feet,” Mark Mortenson, chief science officer at Clene told BioProcess Insider.

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“The new Elkton facility is 74,000+ square feet. In total, we’ve more than quadrupled our production capacity and now have over 100,000 square feet of space associated with making CNM-Au8.”

Furthermore, Mortenson said Clene has future plans to further increase manufacturing capacity by using undeveloped land adjacent to the Elkton facility to build a facility of up to 300,000 square feet in size when needed.

Nanocatalysis platform

Developed using its nanotherapeutic platform, CNM-Au8 is described by the firm as an aqueous suspension of catalytically-active, clean-surfaced, faceted gold nanocrystals that drive critical cellular energetic metabolism in the central nervous system (CNS). If successful, it could offer a new treatment option for patients with neurodegenerative diseases.

“Many neurodegenerative diseases, including ALS, are characterized by multiple interrelated pathological mechanism, including impaired energy metabolism, which culminates in motor neuron energetic failure and results in degeneration and subsequent death of neurons,” Mortenson explained.

Clene’s nanocatalytic therapies are designed to reduce energetic failure by stimulating the production of ATP and reducing oxidative stress, thereby stopping or reversing the neurodegeneration that causes ALS and other diseases.”

He added the candidate’s unique mechanism of action enables neurorepair and neuroprotection by increasing neuronal resilience to energetic failure, collectively resulting in CNS cells’ survival in response to disease-relevant stressors. “To our knowledge, no other treatment under investigation targets energetic failure. This novel approach represents a new paradigm for neuroreparative therapies.”

Water and gold

To make its nanotherapies, Clene flows purified water around wires of highly pure metals – for CNM-Au8, the company uses gold. An alternating current (AC) is then used to remove electrons while inputting gold ions.

“The truly unique part of Clene’s manufacturing process is that the resulting nanocrystals are substantially clean-surfaced and do not have toxic surface residues associated with other techniques for forming metal nanoparticles.”

He continued: “What’s different about Clene’s approach from other companies is that our electrochemical crystal growth process produces clean-surfaced, highly faceted gold nanocrystals. Other metal nanoparticle suppliers generally use chemical reduction techniques, which result in varying levels of toxicity due to, for example, undesirable residual surface chemistries.”