Caris Life Sciences Partners with Debiopharm International SA to Develop Companion Diagnostic for Detection of Rare FGFR Fusions Using Novel Molecular Intelligence (MI) Transcriptome(TM)

Irving, Texas (ots) - Caris to develop CDx for Debiopharm's FUZE
Phase II Pivotal Trial of Debio 1347 in solid tumor patients with
FGFR fusions

Caris Life Sciences®, a leading innovator in molecular science
focused on fulfilling the promise of precision medicine, today
announced that it has entered into a strategic collaboration with
Debiopharm for the development of a companion diagnostic (CDx) test
using its newly-launched Whole Transcriptome Sequencing (WTS) assay
for mRNA analysis called MI Transcriptome(TM). The assay, which was
granted Breakthrough Device Designation by the U.S. Food and Drug
Administration (FDA) in early May, reliably detects rare fibroblast
growth factor receptor (FGFR1, FGFR2 and FGFR3) fusion events.

"This agreement supports our vision for optimizing the detection
of rare fusion events using RNA, and building value on our
multi-platform tumor profiling approach," said W. Michael Korn, M.D.,
Chief Medical Officer at Caris Life Sciences. "We continue to develop
novel technologies to provide the most comprehensive molecular
profiling possible."

Under this agreement, MI Transcriptome(TM) will be used to
identify eligible patients for Debiopharm's FUZE Phase II Pivotal
Trial of Debio 1347, a selective FGFR inhibitor that Debiopharm is
evaluating for the treatment of patients with non-central nervous
system solid tumors that have a specific FGFR gene fusion. Debio 1347
received Fast Track designation from FDA earlier this year.

In addition to developing MI Transcriptome CDx, Caris will use its
MI Trials service to improve the identification of patients eligible
to enroll in the FUZE trial, analyzing the tens of thousands of
patients profiled by Caris Life Sciences each year. The FUZE study is
an open-label, blinded, multicenter, pan-cancer international Phase
II Basket Trial that plans to enroll 125 patients across more than 20
countries.

"This collaboration represents a key milestone in the advancement
of a new tumor-agnostic approach," explained Angela Zubel, Chief
Development Officer at Debiopharm International SA. "We believe that
a whole transcriptome assay is particularly relevant to detect
oncogene fusions and to identify tumor expression profiles that could
benefit from Debio 1347 therapy."

"When investigating novel targeted therapies in small,
genetically-defined subpopulations which can be found in a broad
range of cancers, it is critical that molecular screening be
conducted in the broadest possible group of potential trial
participants," said Keith Flaherty, Director of Clinical Research at
the Massachusetts General Hospital Cancer Center.

"Kinase fusions across multiple histologies have become very
important targets in precision oncology but we know that detection
methods based purely on DNA can unfortunately miss some patients who
might otherwise benefit from these therapies," said David Hyman,
Chief of Early Drug Development at Memorial Sloan Kettering Cancer
Center. "We are excited to see the increasing adoption of RNA-based,
unbiased screening technologies in the clinic."

As opposed to DNA-only based methods, MI Transcriptome(TM) RNA
profiling has the ability to detect any fusion event independent of
breakpoint locations and fusion partners. It can distinguish between
different fusion or rearrangement types and has the potential to
discover previously uncharacterized events, which is critical to
identifying every potential patient who may benefit from targeted
therapies. MI Transcriptome(TM) also uses the capabilities of
high-throughput transcript sequencing to gain insight into the gene
expression profiles of patients' tumors and builds upon Caris'
offering of the most comprehensive tumor profiling approach, which
assesses DNA, RNA and proteins for every patient.

About Caris Life Sciences

Caris Life Sciences® is a leading innovator in molecular science
focused on fulfilling the promise of precision medicine through
quality and innovation. The company's suite of market-leading
molecular profiling offerings assess DNA, RNA and proteins to reveal
a molecular blueprint that helps physicians and cancer patients make
more precise and personalized treatment decisions. Caris is also
advancing precision medicine with Next Generation Profiling(TM) that
combines its innovative service offerings, Caris Molecular
Intelligence® and ADAPT Biotargeting System(TM), with its proprietary
artificial intelligence analytics engine, DEAN(TM), to analyze the
whole exome, whole transcriptome and complete cancer proteome. This
information, coupled with mature clinical outcomes on thousands of
patients, provides unmatched molecular solutions for patients,
physicians, payers and biopharmaceutical organizations. Headquartered
in Irving, Texas, Caris Life Sciences offers services throughout the
U.S., Europe, Asia and other international markets. To learn more,
please visit www.CarisLifeSciences.com or follow us on Twitter
(@CarisLS).

About Debiopharm

Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology. Bridging the gap between disruptive
discovery products and real-world patient reach, we identify
high-potential compounds for in-licensing and clinical development
and then select large pharmaceutical commercialization partners to
maximize patient access across the globe. Visit us
www.debiopharm.com. Follow us @DebiopharmNews.

About Debio 1347

Debio 1347 is an investigational novel orally available small
molecule highly selective FGFR 1, 2, 3 ATP competitive inhibitor.
Results from the phase 1 clinical trial showed that patients with
solid tumors with activating alterations in FGFR may benefit from
treatment with Debio 1347. Debio 1347 is expected to become a
tailored treatment which will be developed with a companion
diagnostic. For more information:
http://patients.debiopharm.com/genetic-alterations/

Pressekontakt:
Caris Life Sciences Company Contact & Media:
Srikant Ramaswami
Vice President, Chief Communications Officer
sramaswami@carisls.com +1-214-769-5510

Caris Life Sciences Investor Inquiries:
David Clair, CFA
Westwicke Partners
David.clair@icrinc.com
+1-646-277-1266

Debiopharm Company Contact:
Dawn Haughton
Communication Manager
dawn.haughton@debiopharm.com
+41 (0)21 321 01 11

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell