CareDx Partners with TC BioPharm to Support ACHIEVE Clinical Trial Using AlloCell for Pharmacokinetic Monitoring of Allogeneic Cell Therapy
December 11 2024 - 7:00AM
Business Wire
CareDx Continues Strategic Expansion into
Hematology Oncology with Pharmacokinetic and Monitoring Assays for
Cell Therapy Patients
CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a
leading precision medicine company focused on the discovery,
development, and commercialization of clinically differentiated,
high-value healthcare solutions for transplant patients and
caregivers – today announced that CareDx will partner with TC
BioPharm to perform pharmacokinetic analysis using its AlloCell™
solution in the ACHIEVE clinical trial.
AlloCell has been used in ten prior cell therapy clinical trials
and with the addition of the ACHIEVE trial is being actively used
in four clinical trials.
The ACHIEVE clinical trial is an adaptive, open-label, phase II
study designed to evaluate the efficacy and effectiveness of
TCB008, an allogeneic gamma-delta T-cell therapy for patients with
Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
“This partnership builds upon our growth strategy to expand into
hematology oncology with pharmacokinetic and monitoring assays for
patients undergoing cell therapy,” said Marica Grskovic, PhD,
CareDx Chief Strategy Officer. “We are thrilled to continue to
progress the science of allogeneic cell therapy for patients
battling acute myeloid leukemia.”
“Our partnership with CareDx is a significant milestone,” said
Alison Bracchi, Executive Vice President of Clinical Operations at
TC BioPharm. “The collaboration is pivotal to the development and
optimization of TCB008 as a therapy for acute myeloid leukemia and
other blood cancers.”
CareDx's AlloCell test, a sensitive solution for pharmacokinetic
monitoring of allogeneic immune and stem cell therapies will be
used to evaluate the expansion and persistence of TCB008 in
patients enrolled in the ACHIEVE trial. It is expected that the
expansion and persistence data will provide an understanding of the
duration and effect of TCB008 gamma-delta T-Cells in reconstituting
the immune system of acute myeloid leukemia patients enrolled in
the ACHIEVE trial.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, California, is a
leading precision medicine solutions company focused on the
discovery, development, and commercialization of clinically
differentiated, high-value healthcare solutions for transplant
patients and caregivers. CareDx offers testing services, products,
and digital healthcare solutions along the pre- and post-transplant
patient journey and is the leading provider of genomics-based
information for transplant patients. For more information, please
visit www.caredx.com.
Forward Looking Statements
This press release includes forward-looking statements related
to CareDx, Inc. and its strategic partnership with TC BioPharm,
including statements regarding the partnership’s ability to drive
innovation, the ACHIEVE clinical trial, and the potential benefits
and results that may be achieved with AlloCell. These
forward-looking statements are based upon information that is
currently available to CareDx and its current expectations, speak
only as of the date hereof, and are subject to numerous risks and
uncertainties, all of which are difficult to predict and many of
which are beyond CareDx’s control, that could cause actual results
to differ materially from those projected, including risks that
CareDx does not realize the expected benefits of the strategic
partnership of the ACHIEVE clinical trial, or of AlloCell itself.
These statements are also subject to general economic and market
factors; and other risks discussed in CareDx’s filings with the
Securities and Exchange Commission (the “SEC”), including, but not
limited to, the Annual Report on Form 10-K for the fiscal year
ended December 31, 2023 filed by CareDx with the SEC on February
28, 2024, the Quarterly Report on Form 10-Q for the quarter ended
March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly
Report on Form10-Q for the quarter ended September 30, 2024 filed
by CareDx with the SEC on November 4, 2024, and other reports that
CareDx has filed with the SEC. Any of these may cause CareDx’s
actual results, performance, or achievements to differ materially
and adversely from those anticipated or implied by CareDx’s
forward-looking statements. You are cautioned not to place undue
reliance on these forward-looking statements. CareDx expressly
disclaims any obligation, except as required by law, or undertaking
to update or revise any such forward-looking statements, whether as
a result of new information, future events or otherwise.
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CareDx Media Contacts Anna Czene 818-731-2203
aczene@caredx.com
Investor Relations Greg Chodaczek investor@caredx.com
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