Medicare Coverage of CAR T-Cell Therapy Holds Positive Implications for LineaRx
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.”