French National Cancer Institute and XBiotech Join forces to Conduct Innovative Phase II/III Adaptive Multicenter Clinical St...
May 03 2021 - 8:00AM
XBiotech (NASDAQ: XBIT) announced today that it had reached an
agreement to supply its new cancer drug XB20-01 to INSERM, and its
Federation of Digestive Oncology group, a French organization which
supports world-leading innovation for treating colorectal cancer.
Colorectal is one of the most common forms of
cancer in Europe and the United States, with nearly 150,000 new
cases and 53,000 deaths expected in the US alone in 2021. The
current chemotherapy regimen uses a Trifluridine/Tipiracil
combination, drugs that interfere with the genetic material of
cells in an effort to kill tumors. However, inflammation and
toxicity from the chemotherapy is offset only by modest response
rates and less than ideal outcomes. Thus, there is significant
unmet medical need for this group of colorectal cancer patients.
XBiotech’s new drug candidate XB20-01 targets an inflammatory
process potentially involved in the growth and spread of colorectal
cancer; and the new drug may also block inflammation caused by
chemotherapy, potentially reducing side effects and improving the
treatment effect of chemotherapy.
The chair and lead investigator of the
multicenter clinical study is Dr. François Ghiringhelli M.D. Ph.D,
Director of INSERM, and Professor of Oncology at the University of
Burgundy, Genetic and Immunotherapy Medical Institute. Dr.
Ghiringhelli, a world-leading researcher in colorectal cancer,
designed the study which features an innovative interim analysis to
assess improvement in overall survival. If patients receiving
XB20-01 have a predetermined improvement in survival compared to
the placebo treated group, the randomized study will be expanded to
enroll a phase III portion with overall survival as the primary
outcome.
Professor Ghiringhelli, also a Director at the
prestigious INSERM center and Head of a Division specializing in
"Cancer and adaptive immune response", commented, “This is a very
exiting clinical trial, granted by the French Cancer Institute, for
a very frequent and devastating disease. Currently very few drugs
give promising results for these patients. In case of success, this
trial could be practice changing.”
John Simard CEO XBiotech stated, “We are honored
to be able to provide our new candidate drug to INSERM, an
institution that is setting a global standard for public
involvement in the promotion of innovation in medicine. François
has developed a brilliant study design that we are very excited to
support.”
Cytotoxic chemotherapy agents result in systemic
toxicity—considered to be a trade-off for potential anti-tumor
activity. Toxicity is of acute importance clinically, but
consequences of inflammatory responses induced by cytotoxic agents
may also have a more profound impact, promoting tumor growth, and
compromising the efficacy and durability of the therapy itself.
Cytotoxic agents upregulate inflammatory pathways, including
activation of leukocytes, vascular endothelium, and stromal cells
of the tumor microenvironment. IL-1a is believed to play a key role
in pro-tumor and treatment related inflammatory pathways.
XBiotech’s new drug XB20-01 is a naturally
occurring antibody that potently neutralizes IL-1a and is thus a
safe and promising approach to block inflammation that occurs with
advanced malignancies and chemotherapy. Unchecked, IL-1a can
stimulate angiogenesis, enhancing blood and nutrient supply to the
tumor; IL-1a may also act to recruit unwanted leukocytes (such as
myeloid suppressor cells) into the tumor, that can suppress the
ability of the body’s immune system to fight off the tumor; and
systemically, IL-1a can mediate metabolic dysfunction, and cause
fatigue, anorexia, and anxiety in cancer patients. IL-1a is thus a
unique target for addressing paraneoplastic inflammation—with
XBiotech’s new drug therapy holding promise for treating a wide
array of cancers.
About True Human™ Therapeutic
AntibodiesXBiotech’s True Human™ antibodies are derived
without modification from individuals who possess natural immunity
to certain diseases. With discovery and clinical programs across
multiple disease areas, XBiotech’s True Human antibodies have the
potential to harness the body’s natural immunity to fight disease
with increased safety, efficacy and tolerability.
About XBiotech XBiotech is
a fully integrated global biosciences company dedicated to
pioneering the discovery, development and commercialization of
therapeutic antibodies based on its True Human™ proprietary
technology. XBiotech currently is advancing a robust pipeline of
antibody therapies to redefine the standards of care in oncology,
inflammatory conditions and infectious diseases. Headquartered in
Austin, Texas, XBiotech also is leading the development of
innovative biotech manufacturing technologies designed to more
rapidly, cost-effectively and flexibly produce new therapies
urgently needed by patients worldwide. For more information, visit
www.xbiotech.com.
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Contact
Emily
Simoneauesimoneau@xbiotech.comTel. 737-207-4606
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