Regulatory Approval Showcases Clinical Advancement of Linea DNA™ as a Rapid and Effective Means of Producing CAR-T cell Therapies
STONY BROOK, N.Y., December 18, 2024 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, announced that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial of an investigational CD123-specific autologous CAR T-cell therapy by the Institute of Hematology and Blood Transfusion (ÚHKT/Eng: IHBT) in Prague for the treatment of relapsed and/or refractory acute myeloid leukemia (AML). UHKT-CAR123-01 utilizes Applied DNA’s synthetic DNA, Linea™ DNA, as a critical component in its manufacture.
AML is a hematologic malignancy with a high rate of treatment failure for which current treatment options are often restricted to palliative approaches. Novel emerging methods leveraging advancements in genetic medicines, such as CAR T-cell therapies, can potentially improve outcomes of patients after relapse but have been difficult to establish for clinical use due to high costs and long manufacturing times predominantly attributable to the use of viral vectors.
UHKT-CAR123 seeks to address these issues by generating CD123-specific CAR T-cells in a non-viral workflow utilizing Linea DNA to reduce manufacturing costs and timelines. Preclinical data showed that ÚHKT’s Linea DNA-empowered non-viral workflow resulted in the rapid production of substantial and cost-efficient CAR T-cell yields with high potency[1].
“The use of Linea DNA illustrates our innovative approach to finding new and best-in-class treatments for patients with relapsed or refractory AML,” stated Dr. Jan Vydra, principal investigator of the UHKT-CAR123 clinical trial.
Added Pavel Otáhal, Ph.D., scientific project leader at ÚHKT, “The Linea DNA platform enables the very rapid abiotic production of expression vectors usable for highly effective electroporation-based CAR-T manufacturing compared to plasmid-based vectors. The decreases in complexities and costs of developing autologous CAR-T technologies offer an innovative approach for the rapid clinical testing of novel types of CAR-T products. This is an incredible milestone for ÚHKT and one that we could not have achieved without the commitment of the Applied DNA team.”
Applied DNA CEO Dr. James A. Hayward, said, “We congratulate ÚHKT on their progress into the clinic. Their accomplishment is also a significant milestone for Linea DNA as we look to support additional customers expected to initiate clinical trials in calendar 2025.”
About Linea™ DNA
Linea™ DNA is an enzymatically produced, linear DNA manufactured by the Company’s proprietary, large-scale polymerase chain reaction (“PCR”) based manufacturing platform, the Linea™ DNA platform. As an alternative to plasmid-based DNA, Linea DNA can be used to manufacture of a wide range of nucleic acid-based therapies and in vitro diagnostics, including mRNA therapies, DNA vaccines, cell and gene therapies, and molecular and genetic diagnostic tests.
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid (“DNA”). Using the polymerase chain reaction (“PCR”) to enable both the production and detection of DNA, we currently operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase (“RNAP”) for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
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Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, the unknown future demand for its biotherapeutics and/or diagnostic products and services, the unknown amount of revenues and profits that will result from its Linea IVT and or Linea DNA platforms, the unknown outcome of the IHBT clinical trial, unforeseeable adverse events that could be encountered in the IHBT clinical trial, the fact that there has never been a commercial drug product utilizing the Linea DNA and/or the Linea IVT platform approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including its Annual Report on Form 10-K filed on December 17, 2024, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events unless otherwise required by law.
[1] LINEAR DNA PLATFORM FOR THE NON-VIRAL POINT-OF-CARE PRODUCTION OF. . . by Pavel Otáhal. Copyright (C) 2024 MULTILEARNING Group Inc. https://library.ehaweb.org/eha/2024/eha2024-congress/419809/pavel.othal.linear.dna.platform.for.the.non-viral.point-of-care.production.of.html
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