Full Press Release Details
Assets and Intellectual Property of Vitatex
for Functional Isolation of Invasive Circulating Tumor Cells Empowers Three LineaRx Product Categories: Diagnostics, Prognostics
Integrated Product and Service Offering
STONY BROOK, NY. August 8,
2019 - LineaRx, Inc. ("LineaRx"), a wholly-owned subsidiary of Applied DNA Sciences, Inc. ("Applied
DNA or the Company," NASDAQ: APDN), announced today that it has acquired the physical assets and Intellectual Property (IP)
of Vitatex Inc. ("Vitatex"), a private biotechnology company focused on advancing personalized medicine with
an innovative solution that isolates Invasive Circulating Tumor Cells (iCTCs) from standard patient blood samples. Vitatex's
solution identifies metastatic cells often before primary tumors are visible to other diagnostic technologies, when preventative
care for impending cancer is still an option.
"We are honored to now
include Vitatex executives on our team and employ its powerful technology within our platform," said Dr. James Hayward,
president and CEO of LineaRx. "We believe that the sophisticated technology sets us apart and integrates closely with the
LineaRx service and technology offerings, broadening our addressable markets and shortening our development cycle."
Invasive Circulating Tumor Cells
(iCTCs) are isolated from the blood using Vitatex's patented, novel functional assay that requires the cells to duplicate
the metastatic behaviors of intravasation (leaving a primary tumor and initiating escape through a capillary or lymphatic vessel)
and extravasation (exiting capillaries and lymphatic vessels and entering organs to form aggressive secondary tumors.) These assays
are highly personalized and offer information regarding the metastatic potential of each individual's unique cancer. The
worldwide market for CTC technologies is projected to reach $17.6 billion by 2025 at a 20% CAGR over the period[1].
In contrast to competitive technologies
that only recognize parts of cancer DNA, the Vitatex platform captures living cancer cells that enter the blood stream at very
low rates. As such, they can be cultured and challenged against panels of cancer therapies to optimize selection of treatment
tailored to each patient. Genomic information gathered from the iCTCs and associated lymphocytes that have already recognized
the iCTCs as cancer can be used to target individualized cancer antigens (neoantigens) in immune therapies such as CAR T.
"We are thrilled to be
joining LineaRx, whose technologies we believe will alter the future of cancer therapy. Our combined platforms offer opportunities
to diagnose cancer early, personalize redirected cell therapies, and predict outcomes across many cancer indications," stated
Dr. Wen-Tien Chen, Research Professor of Medical Oncology at Stony Brook University, and the founder and president of Vitatex.
Dr. Chen, who joins LineaRx as
a Consulting Emeritus Scientist and Principal Investigator, discovered the enzyme seprase while serving as Director of the Tumor
Invasion and Metastasis Program at Georgetown University. Seprase is a protease (a protein-digesting enzyme) secreted at the invasive
front of metastasizing cancers. Included in the IP acquired by LineaRx, are several hybridoma cell lines, including one that produces
antibodies directed against seprase. These antibodies have potential both as therapeutics as well as for characterizing iCTCs
Dr. Michael Pearl, Professor of Gynecological Oncology and Medical
Director of the Cancer Center Clinical Trials Office at Stony Brook University Hospital, and author of multiple papers on iCTCs,
stated: "Although the prevalence of ovarian cancer is very low there is a high unmet need for better therapies. As we have
recently shown, the positive predictive value (PPV) of using iCTCs as a screening test for patients who are at high risk, raises
the PPV to well over 97%."
LineaRx plans to work with existing companies in the diagnostic
market and enhance the functionality and sensitivity of their cancer diagnostic assays. Longer term, the Vitatex platform is intended
to be used to generate ultra-personalized redirected cell therapies, produced at the point of care, to cancers with high mutation
burdens that also have the greatest metastatic potential. LineaRx intends to develop and out-license the technology as an early
cancer diagnostic, and a prognostic to follow the course of contemporary cancer therapies including such redirected cell therapies
as CAR T (T cells redirected against a patient's cancer by an inserted nucleic acid that codes for Chimeric Antigen
Receptors), and, to develop therapeutics that utilize LineaRx's unique DNA manufacturing based upon large-scale polymerase
chain reaction (PCR).
LineaRx intends to design synthetic genes to redirect immune
cells against antigens that are recognized by leukocytes that comigrate with the iCTCs, one of the unique features of the Vitatex
platform. Vitatex has been the beneficiary of more than $7 million of NCI funding over the course of its history, and LineaRx has
already begun the application for a new contract to support commercialization, with matching funds from commercial partners. Dr.
Chen continued, "We believe LineaRx has the commercial and compliance experience to bring our technologies quickly to commercial
practice to aid the cancer community."
Two senior members of the Vitatex team have joined the parent
company of LineaRx, Applied DNA: Qiang Zhao, MD and Huan Dong, Ph.D. A Licensing Agreement was also signed between LineaRx and
The Research Foundation for The State University of New York, since the discoveries claimed in the licensed patents were made on
the campus of Stony Brook University. Peter Donnelly, Associate Vice President for Technology Partnerships for Stony Brook University
stated: "We are pleased to expand our relationship with one of our community's most productive and insightful entrepreneurs.
The management at LineaRx has the experience, technical and compliance insights, and indefatigable drive to bring these technologies
The acquisition of Vitatex by LineaRx was structured as an "earn-out,"
allowing LineaRx to realize value before paying for it. Initial payment comprised $300,000 worth of equity in LineaRx at a valuation
of $25 million for LineaRx. Subsequent payments are milestone-based, rising to a maximum of $1 million in value, comprising a total
of $800,000 in LineaRx equity (based on the then-current market capitalization of LineaRx) and $200,000 in cash.
Dr. Kenneth Kaushansky, senior vice president of Health Sciences
for Stony Brook University, and Dean of the Renaissance School of Medicine, and himself an expert on myeloproliferative cancers,
stated: "Dr. Chen has invented and patented a fundamentally new technology for the capture and subsequent analysis of CTCs.
With much excitement, we have watched the commercial progress of that technology as it has developed via multiple rounds of highly
competitive SBIR funding, here at the Stony Brook University Medical Center. As have many others, we have been fascinated by the
potential for such CTC-based approaches to cancer diagnostics. But arguably, what has been generally lacking in the field of CTC
diagnostics is the ability to capture such CTCs based on the functional characteristics of a tumor cell, which the Vitatex technology
is uniquely positioned to deliver. The recent pairing with LineaRx will provide the opportunity to take the Vitatex CTC technology
to the next level, in terms of manufacturing scale-up, ISO and cGMP validation and the direct coupling of the Vitatex technology
to a wide range of "best in breed" DNA-based and protein-based diagnostic assay technologies, which LineaRx already
supports with its other commercial partners."
Dr. Hayward summarized: "Dr. Chen's lifetime contribution
to the understanding of the mechanisms of cancer metastasis are inestimable. We are very fortunate to be able to work with his
team to evolve and commercialize these technologies to improve the lives of cancer patients."
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. Go to www.adnas.com for more information on LineaRx
and to learn more about how Applied DNA makes life real and safe.
| About Applied DNA Sciences | |
| 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. |
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Common stock listed on NASDAQ under
the symbol APDN, and warrants are listed under the symbol APDNW.
Forward-Looking Statements
The statements made by
Applied DNA in this press release may be "forward-looking" in nature within the meaning of the Private Securities Litigation
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 risk that the acquisition will not be successfully integrated
with LineaRx or that the potential benefits of the acquisition will not be realized, the Company's 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 product candidates will advance further in the preclinical research