IRVING, Texas and SOUTH SAN FRANCISCO, Calif., Oct. 25, 2016 /PRNewswire/ -- Caris Life
Sciences, a leading biotechnology company focused on fulfilling the
promise of precision medicine, and Threshold Pharmaceuticals, Inc.
(Nasdaq: THLD), a clinical-stage biopharmaceutical company
specializing in the development of novel pharmaceutical products
for the treatment of cancer, today announced that they have entered
into a development and commercialization agreement to utilize
Caris' patented and proprietaryADAPT Biotargeting
System™ to develop a tissue-based clinical diagnostic
assay for pancreatic cancer patients to predict the likelihood of
response to evofosfamide, Threshold's lead drug candidate for the
potential treatment of patients with cancer. Under the terms of the
agreement, Caris is eligible to receive several million dollars in
clinical development milestones and undisclosed downstream royalty
payments. Through Caris' proprietary ADAPT Biotargeting System,
Threshold may gain access to a diagnostic tool that will enable
physicians to determine which patients would be most likely to
benefit from treatment with evofosfamide.
"We are pleased to work with Threshold Pharmaceuticals to
support the development of their novel potential therapy, which has
shown promising results in this difficult-to-treat disease," said
Bart Howe, Executive Vice President
of Business Development and Corporate Strategy at Caris. "Our
innovative and revolutionary ADAPT Biotargeting System is uniquely
positioned to support the pharmaceutical clinical development
process by identifying complex molecular signatures that can
predict a patient's likelihood of response to a particular
therapy."
"Since it is well understood that patients exposed to the same
chemotherapy often respond differently, we look forward to working
with Caris and their innovative ADAPT Biotargeting System to help
physicians identify those patients most likely to benefit from
evofosfamide," said Barry Selick,
Ph.D., Chief Executive Officer of Threshold. "We remain optimistic
about the potential role of evofosfamide for the treatment of
cancer, and we continue to pursue discussions with Japanese
regulatory authorities regarding potential registration pathways
for evofosfamide and other development opportunities with
evofosfamide."
Caris and Threshold will work together, leveraging tumor samples
and outcomes data from the previously completed Phase 3 MAESTRO
study in patients with advanced pancreatic cancer, to develop a
novel, multiplexed diagnostic assay designed to classify a
patient's likely clinical outcome from the use of evofosfamide.
Evofosfamide (previously known as TH-302) is an investigational
hypoxia-activated prodrug of a DNA cross-linking agent that is
preferentially activated under hypoxic tumor conditions, a feature
of many solid tumors. In December
2015, Threshold announced that a Phase 3 study (MAESTRO) of
evofosfamide had not met its primary endpoint. However, data
from the MAESTRO study demonstrated meaningful improvement in
overall survival in a subgroup of 116 patients from Japan, in which the risk of death was reduced
by 48 percent for patients receiving evofosfamide compared to
patients in the control arm.
Caris' ADAPT Biotargeting System is a proprietary platform that
uses libraries of synthetically manufactured molecules trained to
bind to biological targets of interest in order to characterize
complex biological systems. Currently being utilized in discovery
research, advanced diagnostics and drug development programs across
multiple diseases, the ADAPT Biotargeting System also has potential
utility in drug delivery, disease monitoring and direct therapeutic
applications.
About Caris Life Sciences®
Caris Life
Sciences® is a leading biotechnology company focused on
fulfilling the promise of precision medicine through quality and
innovation. The company's ADAPT Biotargeting System™ is a
revolutionary and unbiased profiling platform with applications
across therapy development, drug delivery, advanced diagnostics and
disease monitoring. Currently being developed for cancer and other
complex diseases, the ADAPT Biotargeting System is able to
simultaneously measure millions of molecular interactions within
complex biological systems in their natural state(s). Caris also
offers comprehensive tumor profiling services through its patented
and proprietary product, Caris Molecular Intelligence®
(CMI). With more than 100,000 clinical cases, CMI provides
oncologists with the most clinically actionable treatment options
available to personalize cancer care today. Headquartered in
Irving, Texas, Caris Life Sciences
offers services throughout the U.S., Europe, Australia and other international markets. To
learn more, please visit www.CarisLifeSciences.com.
About Threshold Pharmaceuticals
Threshold
is a clinical-stage biopharmaceutical company focused on the
discovery and development of drugs and diagnostic agents targeting
tumor hypoxia, the low oxygen condition found in microenvironments
of most solid tumors as well as the bone marrows of some
hematologic malignancies. This approach offers broad potential to
treat a variety of cancers. By selectively targeting tumor cells,
we are building a pipeline of drugs that hold promise to be more
effective and less toxic to healthy tissues than conventional
anticancer drugs. For additional information, please visit the
Company's website at www.thresholdpharm.com.
Threshold Pharmaceuticals Forward-Looking
Statements
Except for statements of historical fact, the
statements in this press release are forward-looking statements,
including all statements regarding the therapeutic potential of
evofosfamide and a companion diagnostic; Threshold's plans to
continue to focus its resources on evofosfamide and a companion
diagnostic; anticipated development activities related to
evofosfamide and a companion diagnostic, and the anticipated timing
thereof; Threshold's plans to continue to pursue discussions
regarding potential registration pathways for evofosfamide
in Japan, and the potential for evofosfamide to be approved
for marketing in Japan. These statements involve risks and
uncertainties that can cause actual results to differ materially
from those in such forward-looking statements. Potential risks and
uncertainties include, but are not limited to: the difficulty and
uncertainty of pharmaceutical and companion diagnostic product
development, including the risks that the design of, or data
collected from the Phase III MAESTRO clinical trial of evofosfamide
may be inadequate or insufficient to support development of a
companion diagnostic for evofosfamide; the uncertain and
time-consuming regulatory approval process, including the risk that
data from the completed MAESTRO clinical trial will not be
sufficient to support the approval of evofosfamide for the
treatment of patients with pancreatic cancer in Japan;
Threshold's need for and the availability of resources to develop
evofosfamide or a companion diagnostic and to support Threshold's
operations, including the risks that Threshold's
currently-available resources may be insufficient to further
current development plans for evofosfamide or a companion
diagnostic and that Threshold will otherwise need to raise
substantial additional capital in order to advance the clinical
development of evofosfamide or a companion diagnostic; the risks
that Threshold could determine to abandon the development of
evofosfamide or a companion diagnostic as a result of inadequate
resources, negative or inconclusive clinical trial or toxicology
study results, the failure to obtain regulatory approval of
evofosfamide in Japan, or otherwise. Further information
regarding these and other risks is included under the heading "Risk
Factors" in Threshold's Quarterly Report on Form 10-Q, which has
been filed with the Securities and Exchange
Commission on August 1, 2016 and is available from
the SEC's website (www.sec.gov) and on our website
(www.thresholdpharm.com) under the heading "Investors." We
undertake no duty to update any forward-looking statement made in
this news release.
Caris Media Inquiries:
Brian
Stengle
Caris Life Sciences Media Relations & Corporate Affairs
CorpComm@carisls.com
214-294-5606
Threshold Media Inquiries:
Denise Powell
denise@redhousecomms.com
510.703.9491
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SOURCE Caris Life Sciences