Oncocyte’s VitaGraft™ Kidney Used to Monitor Effect of Daratumumab on Anti-body Mediated Rejection in New Case Series Study
12 Agosto 2024 - 5:10PM
Oncocyte Corp. (Nasdaq: OCX), a molecular diagnostics technology
company, announced the recent publication of a case series of two
kidney transplant patients who were monitored for antibody-mediated
rejection (AMR) using its proprietary VitaGraft™ Kidney
diagnostic test. Patients were tested before, during and after
treatment with daratumumab, an anti-CD38 monoclonal antibody1. The
study underscores the significant potential of using repeated
VitaGraft Kidney measurements to monitor the efficacy of anti-CD38
therapy.
VitaGraft Kidney is a noninvasive biomarker2 that quantifies the
concentration of donor kidney DNA in the patient’s blood after
transplantation. This donor-derived cell-free DNA (dd-cfDNA) test
is currently approved by CMS for identifying signs of graft damage
in patients with clinical suspicion of rejection.
The case series reports on two patients with biopsy-confirmed
chronic active AMR, one of the leading causes of allograft kidney
failure, treated with monthly daratumumab infusions and monitored
longitudinally with VitaGraft Kidney dd-cfDNA testing. After
daratumumab treatment, both patients showed stabilization of kidney
function parameters and a steep decline in dd-cfDNA levels below
the clinical threshold for rejection. Biopsies six months after
treatment demonstrated complete histologic resolution of AMR
activity in one patient and partial resolution in the other. The
patient with complete resolution showed a significant decline in
dd-cfDNA levels to the lower limit of detection, and although the
patient with partial improvement in AMR showed slightly higher
dd-cfDNA levels, the patient still remained below the rejection
threshold.
Today’s announcement represents the second publication that
shows Oncocyte’s ability to monitor therapeutic efficacy. In a
recent phase 2 randomized controlled trial published in The New
England Journal of Medicine, VitaGraft Kidney was also used to
measure the response to another anti-CD38 antibody, felzartamab,
for patients with AMR after kidney transplantation. The study noted
that dd-cfDNA levels after treatment corresponded to the rejection
observed in biopsies at 52 weeks.
“VitaGraft Kidney has high potential to be the most useful
biomarker for monitoring the effectiveness of anti-CD38 therapy for
AMR,” said Dr. Ekkehard Schütz, Oncocyte’s Chief Science Officer
and one of the authors of both studies. “This test could facilitate
not only early diagnosis of AMR but also longitudinal measurements
of treatment response and possible post-treatment graft recurrence
over the long term.”
These new use cases could guide individual management decisions,
such as dosing and duration of anti-rejection therapy, while
reducing the need for repeated biopsies. By enabling detection,
management and monitoring of AMR, VitaGraft could improve graft
longevity.
Oncocyte’s mission is to democratize access to
molecular diagnostic testing to improve patient outcomes. The
company is investing in developing products to serve the separate
verticals of organ transplant testing and oncology. Oncocyte
presently is commercializing its transplant product line, which
includes the VitaGraft™ and GraftAssure™ dd-cfDNA tests.
Specifically, GraftAssure is being launched globally with the
support of Bio-Rad Laboratories, a leading diagnostics equipment
company. Oncocyte received a positive coverage determination from
Palmetto GBA, a Medicare Administrative Contractor for the Centers
for Medicare & Medicaid Services (CMS), for VitaGraft Kidney in
2023.
About Oncocyte
Oncocyte is a molecular diagnostics technology
company. The company’s tests are designed to help provide clarity
and confidence to physicians and their patients. VitaGraft™ is a
clinical blood-based solid organ transplantation monitoring test.
GraftAssure™ is a research use only (RUO) blood-based solid organ
transplantation monitoring test. DetermaIO™ is a gene expression
test that assesses the tumor microenvironment to predict response
to immunotherapies. DetermaCNI™ is a blood-based monitoring tool
for monitoring therapeutic efficacy in cancer patients. For more
information about Oncocyte, please
visit https://oncocyte.com/. For more information about our
products, please visit the following web pages:
VitaGraft Kidney™
- https://oncocyte.com/vitagraft-kidney/VitaGraft Liver™
- https://oncocyte.com/vitagraft-liver/GraftAssure™
- https://oncocyte.com/graftassure/DetermaIO™
- https://oncocyte.com/determa-io/DetermaCNI™
- https://oncocyte.com/determa-cni/
VitaGraft™, GraftAssure™, DetermaIO™ and DetermaCNI™ are
trademarks of Oncocyte Corporation.
Forward-Looking Statements
Any statements that are not historical fact (including, but not
limited to statements that contain words such as “will,”
“believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,”
and similar expressions) are forward-looking statements. These
statements include those pertaining to, among other things,
VitaGraft Kidney’s potential utility, Oncocyte’s ongoing
commercialization efforts, and other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management. Forward-looking statements involve risks and
uncertainties, including, without limitation, risks inherent in the
development and/or commercialization of diagnostic tests or
products, uncertainty in the results of clinical trials or
regulatory approvals, the capacity of Oncocyte’s third-party
supplied blood sample analytic system to provide consistent and
precise analytic results on a commercial scale, potential
interruptions to supply chains, the need and ability to obtain
future capital, maintenance of intellectual property rights in all
applicable jurisdictions, obligations to third parties with respect
to licensed or acquired technology and products, the need to obtain
third party reimbursement for patients’ use of any diagnostic tests
Oncocyte or its subsidiaries commercialize in applicable
jurisdictions, and risks inherent in strategic transactions such as
the potential failure to realize anticipated benefits, legal,
regulatory or political changes in the applicable jurisdictions,
accounting and quality controls, potential greater than estimated
allocations of resources to develop and commercialize technologies,
or potential failure to maintain any laboratory accreditation or
certification. Actual results may differ materially from the
results anticipated in these forward-looking statements and
accordingly such statements should be evaluated together with the
many uncertainties that affect the business of Oncocyte,
particularly those mentioned in the “Risk Factors” and other
cautionary statements found in Oncocyte’s Securities and Exchange
Commission (SEC) filings, which are available from the SEC’s
website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Oncocyte undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
CONTACT:Jeff RamsonPCG Advisory(646)
863-6893jramson@pcgadvisory.com
1 CD38 is a protein found on the surface of many immune cells
and targeted in some therapies for cancer. Daratumamab is a
targeted cancer drug. Anti-CD38 antibodies such as daratumumab are
being studied for the treatment of allograft injury and rejection
mediated by immune cells that express CD38, such as natural killer
cells in AMR. 2 VitaGraft Kidney measures the amount of DNA in
transplant patients’ blood that comes from the donor organ, a key
biomarker for assessing graft health. This process is commonly
referred to as donor-derived cell-free DNA (dd-cfDNA) testing and
is widely used in clinical practice today. Oncocyte has previously
demonstrated that VitaGraft Kidney can detect AMR up to 10 months
earlier than current transplant rejection monitoring protocols.
Oncocyte (NASDAQ:OCX)
Gráfico Histórico do Ativo
De Jul 2024 até Ago 2024
Oncocyte (NASDAQ:OCX)
Gráfico Histórico do Ativo
De Ago 2023 até Ago 2024