Institute of Hematology and Blood Transfusion (Prague) to Present on Successful Use of Applied DNA's Linea DNATM for the Non-Viral Manufacture of CAR T-Cell Therapy for Refractory AML

STONY BROOK, NY / ACCESSWIRE / May 13, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, and the Institute of Hematology and Blood Transfusion (ÚHKT/IHBT) today announced that an abstract relating to the development of a fully enzymatic, non-viral manufacturing workflow to enable the rapid and cost-effective production of clinical-grade (GMP) CAR T-cell therapies has been accepted for presentation at the prestigious European Hematology Association 2024 Hybrid Congress to be held in Madrid, Spain from June 13 - 16, 2024. Accepted abstracts will be available on the Congress' website starting on May 14, 2024. This current study extends the successful results previously published on the virus-free preparation of CD19-specific CAR T-cells against refractory B cell malignancies utilizing Applied DNA's Linea™ DNA.

The current study was designed to address the high cost of conventional CAR T-cell therapies, which is primarily due to conventional manufacturing processes that utilize difficult-to-manufacture viral vectors. By generating CD123-specific CAR T-cells in a non-viral workflow via piggyBac transposons made from Linea DNA at substantial and cost-efficient yields with no risk of antibiotic-resistance gene transfer, we believe the study could offer a promising solution for the rapid manufacture of CAR T-cell therapies. IHBT is currently seeking SÚKL-EMA approval to initiate clinical trials using its Linea DNA-enabled CD123-specific CAR T-cells in patients with refractory acute myeloid leukemia.

Details of the oral presentation:

Abstract Title: "Linear DNA Platform For The Non-Viral Point-Of-Care Production Of Car-T Cells"

Abstract Number: P1722

Presenting Author: Dr. Pavel Otáhal

About the Linea™ DNA and Linea™ IVT Platforms

The Linea DNA platform is a completely cell-free DNA production platform founded on Applied DNA's long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea™ RNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.

Learn more about the Linea™ DNA and Linea™ IVT platforms: LineaRx, an Applied DNA Sciences company

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 operate in three primary business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. ("Spindle"), 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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About ÚHKT

Ústav hematologie a krevní transfuze/Institute of Hematology and Blood Transfusion (IHBT) was founded in Prague on 1 January 1952, together with a number of other departmental research institutes of the Ministry of Health. Over the sixty years of its existence, it has become a prestigious institution combining specialized medical care and diagnostics with intensive research activities in the field of hematology and blood transfusion.

IHBT in numbers:

• We carry out more than 21,000 treatments a year in our Outpatient Department
• We admit more than 500 patients a year on 40 beds
• We perform over 6,000 procedures a year in the Day Hospital
• IHBT has 467 staff members

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 substantial doubt about its ability to continue as a going concern, unknown future demand for its biotherapeutics products and services, the inherent risk and unknown outcome of research and development projects, the unknown amount of revenues and profits that will result from the Linea DNA™ and/or Linea™ IVT platforms, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT or Linea DNA platforms approved for human therapeutic use, the unknown ability of IHBT to gain regulatory approval for the clinical use of its CAR T-cell therapies, 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 7, 2023, its Form 10-Q filed on February 8, 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.

Contacts:

Applied DNA Sciences
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
Web: www.adnas.com
Twitter: @APDN

IHBT
Program contact: doc.MUDr. Pavel Otáhal, Ph.D., +420 221 977 222, pavel.otahal@uhkt.cz
Web: www.uhkt.cz/uhkt

SOURCE: Applied DNA Sciences, Inc.