STONY BROOK N.Y.--(BUSINESS WIRE)--Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) announced today that LineaRx, Inc. (“LineaRx”), its majority-owned subsidiary focused on next-generation biotherapeutics and cancer diagnostics, has signed a licensing agreement with LifeSensors, Inc. (“LifeSensors”), to incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications (the “Agreement”). LifeSensors’ SUMO-fusion technologies enable the attachment of the C-terminus of SUMO (Small Ubiquitin Like Modifier) to the N-terminus of a protein of interest that can dramatically improve protein solubility, achieve native protein folding, and increase total yield by improving expression and decreasing degradation.
Under the terms of the Agreement, LineaRx will have a worldwide license to the applicable LifeSensors intellectual property to make, have made, use, and sell DNA constructs incorporating the SUMO-fusion technologies for therapeutic and diagnostic applications.
“We have already demonstrated expression levels for our linear DNA that meets or exceed that of plasmid-produced DNA,” stated Dr. James Hayward, president and CEO of Applied DNA. “The incorporation of the SUMO-fusion technologies into our linear amplicons we believe will further optimize protein expression and deliver yet another strength to linear DNA. We are in discussions with therapeutic companies on incorporating the SUMO-fusion technologies into their custom amplicon for the therapy of interest.”
“A roadblock to successful gene therapy today is the ability to effectively express and present the therapeutic product in the target cell. Fusion of gene constructs and chimeric genes with SUMOstar overcomes the hurdles of poor gene expression,” said Brenda Bausher, Manager of LifeSensors, Inc.
The companies will work together on initially developing and releasing two high expression amplicons; one for the generic Luciferase protein and one for our licensed anti-CD19 therapy.
Data showing the increased expression levels resulting from incorporation of SUMO-fusion technologies are expected to be available over the next few months.
“This Agreement demonstrates the commitment we have to optimize PCR-produced linear DNA for therapeutic applications. We expect that LifeSensors’ proven technology will further strengthen our higher performing alternative to plasmids for nucleic acid-based therapies,” concluded Dr. Hayward.
About LineaRx, Inc.
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.
In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.
When linear DNA enters the nucleus, it does not need to be incorporated into the genome in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.
Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.
About LifeSensors, Inc.
LifeSensors is a biotechnology company focused on SUMO and ubiquitin proteasome and PROTAC drugs, develops and markets technologies for application in protein expression and drug discovery. LifeSensors technologies are employed by academic, government research institutions, pharmaceutical and biotechnology companies worldwide in efforts to improve the quality of human life.
For more information on our new line of products, please refer to the LifeSensors web site at www.lifesensors.com.
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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and other reports we file 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.