Medicare Coverage of CAR T-Cell Therapy Holds Positive Implications for LineaRx
August 12 2019 - 9:00AM
Business Wire
LineaRx Positioned to Benefit from Increasing
Demand for Nucleic-Acid Dependent Therapies; Potential to Make
Redirected Cell Therapies, such as CAR T, Faster, Safer, More
Effective and with Lower Design and Manufacturing Costs
LineaRx, Inc. (“LineaRx”), a majority-owned subsidiary of
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the
“Company”) announced that, in a decision rendered on August 7,
2019, the Centers for Medicare and Medicaid Services (CMS) approved
chimeric antigen receptor (CAR) T-cell therapies that fit the CMS
criteria for Medicare beneficiaries nationwide. LineaRx believes
its unique method of manufacturing DNA is well poised to benefit
from the increasing demand for nucleic-acid dependent therapies,
like CAR T, as biotechnology companies pursue their gene and cell
therapies with reimbursement assured by the CMS decision.
CAR T-based treatments involve extracting and genetically
altering a patient’s T cells to attack a protein on the surface of
cancer cells. The cells are then infused back into the patient. All
approved CAR T and other redirected cell therapies are manufactured
using DNA that is bacterially derived and then delivered to the
patient’s T cells by a virus. Such plasmids-based treatments
require about three weeks to grow and are acknowledged to have the
potential for unintended side-effects. LineaRx offers a cleaner,
potentially higher-performing alternative to plasmid DNAs with
linear DNAs produced by PCR (Polymerase Chain Reaction) that are
used to reprogram CAR T cells. Applications for redirected cells
are broadly anticipated with more than 850 trials globally listed
on clinicaltrials.gov.
“The oncology community has greeted CAR T cell therapy with
extraordinary enthusiasm, but the use of these novel therapies to
combat cancer has been constrained by pricing and reimbursement.
With the CMS decision, redirected cell therapies are now a
permanent part of the toolbox of modern medicine, and with LineaRx,
we believe we have a more desirable manufacturing process than
plasmids, that will enable biotech companies to accelerate their
commercialization efforts,” stated Dr. James Hayward, president and
CEO of LineaRx. “With the LineaRx ability to provide massive
ultrapure DNA with shorter lead times than plasmids, its
manufacturing technology should enable gene therapy companies to
shorten time-to-market for their therapies and in a much more
cost-efficient manner. Patients will also benefit by a more rapid
turnaround. Moreover, we believe that our recent acquisition of
Vitatex, which just closed last week, facilitates our development
of redirected cell therapies by enabling us to study the
lymphocytes that we capture alongside the circulating tumor cells
from the blood of cancer patients. We believe these studies will
guide us toward optimal design of the engager that allows CAR T
cells to recognize their host’s cancer at a molecular level.”
Full text of CMS decision: Decision Memo for Chimeric Antigen
Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)
About LineaRx
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. LineaRx is a
majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN)
company.
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.
Visit adnas.com for more information. Follow us on Twitter and
LinkedIn. Join our mailing list.
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
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, ability to maintain its
NASDAQ listing in light of delisting notices received 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 18, 2018, as amended, and our subsequent quarterly
reports on Form 10-Q filed on February 7, 2019 and May 9, 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 to reflect the
occurrence of unanticipated events, unless otherwise required by
law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190812005143/en/
investors: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com program: Brian Viscount,
631-240-8877, brian.viscount@adnas.com web: www.adnas.com
twitter: @APDN, @LineaRxDNA
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Applied DNA Sciences (NASDAQ:APDN)
Historical Stock Chart
From Apr 2023 to Apr 2024