On November 9, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported that it has successfully manufactured and shipped its first research use only quantity of self-amplifying mRNA (saRNA) template generated by its Linea DNA platform (the "Platform") to an unidentified preclinical therapeutic mRNA developer (Press release, Applied DNA Sciences, NOV 9, 2023, View Source [SID1234637350]).
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saRNA is a promising new form of mRNA therapy engineered to possess a self-replicating capability. Unlike conventional non-amplifying mRNA, saRNA carries the machinery necessary for its replication, resulting in a higher therapeutic index at a lower dose. Due to these advantages, interest in saRNA is rapidly growing, as evidenced by 10 active saRNA vaccine clinical trials as of Jan. 20231 and numerous companies engaged in preclinical studies to use saRNA to treat indications ranging from cancer to protein replacement therapies. Like mRNA, saRNA is also produced from a DNA template.
The manufacturing of saRNA, however, has proven to be challenging due to the large size and complexity of saRNA and its associated DNA IVT templates. The DNA templates for saRNA are often 3x-5x larger than the DNA templates for conventional non-amplifying mRNA. saRNA can also be challenging to produce efficiently in DNA plasmids, often leading to heterogeneous DNA sequences, low yields, and long manufacturing timelines.
In contrast, the Company’s Platform can rapidly and efficiently enzymatically produce the challenging DNA sequences necessary to produce saRNA with high levels of homogeneity, particularly in challenging sequences such as the poly(T) homopolymers required to produce saRNA. Due to these Platform advantages, the Company is working with additional customers to produce preclinical saRNA IVT templates.
"RNA technology is today central to the development of biologics for human health, and DNA is its manufacturing starting point," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Development pipelines are beginning to see an uptake of saRNA for next-generation mRNA therapies. We believe our Platform’s ability to enzymatically produce the challenging and large DNA sequences needed to manufacture saRNA at scale puts us at the forefront of template manufacturing for this promising and growing mRNA modality."