XBiotech (NASDAQ: XBIT) announced today that the FDA has granted
permission to commence clinical trials with its novel drug
candidate for treating patients with pancreatic cancer. From 1992
to 2018 the death rate from pancreatic cancer steadily increased in
the USA. It is now predicted that pancreatic cancer will claim
48,220 lives and be the 3rd leading cause of cancer death in the
USA in 2021 (National Cancer Institute’s Surveillance,
Epidemiology, and End Results (SEER) program).
Pancreatic cancer is typically identified at an
advanced stage and treatment often includes surgery and aggressive
chemotherapy. A current approved treatment involves combination
chemotherapy including ONIVYDE and 5-fluorouracil, drugs that have
significant toxicities and provide only modest response rates.
XBiotech’s new drug candidate (XB2001) specifically targets a
process potentially involved in the growth and spread of malignant
tumors; and the drug also blocks inflammation associated with
tissue injury, which may reduce toxicity associated with the
chemotherapy and allow these drugs to be better tolerated and more
effective.
The Phase I/II clinical study will evaluate
XBiotech’s new drug candidate when added to the ONIVYDE/5-FU
combination therapy. The clinical study is chaired by Dr. Shubham
Pant, a leading researcher and oncologist at MD Anderson Cancer
Center; and will involve at least 15 other top cancer centers
around the United States. The Phase 1 portion of the study will
examine increasing doses of XBiotech’s new drug and assess
tolerability of the combination at escalating doses. Once a safe
dose has been determined, the phase 2 portion will begin, enrolling
60 patients, which will be randomized to receive treatment with
ONIVYDE/5-FU or ONIVYDE/5-FU combined with XB2001. Clinical
endpoints in the study are safety, overall survival, objective
response rate, progression free survival, time to treatment
failure, clinical benefit response, number of severe adverse
advents, as well as biological measures of experimental drug
activity.
Dr. Razelle Kurzrock, M.D., Murray Professor of
Medicine, Clinical Science Director, Center for Personalized Cancer
Therapy, University of California, San Diego commented, “We need
more effective treatments for pancreatic cancer and I believe
IL-1a, the target of XB2001, represents an important novel target
in oncology. This novel drug approach may both antagonize the
biology of the tumor and mitigate chemotherapy-related
toxicities—offering hope for improved outcomes in cancer, including
tumors of the pancreas.”
John Simard, Chairman and CEO of XBiotech,
stated, “The launch of our new drug into this challenging area of
oncology speaks to our strong conviction to the mechanism of this
drug and the substantial unmet medical need for patients suffering
from pancreatic cancer.”
Several classes of therapeutics are undergoing
development for pancreatic cancer, such as new cytotoxic
chemotherapy, so called PKIs and immunotherapies. However, each of
these treatments approaches are expected to provide, at best,
modest improvements in survival and are not expected to replace
existing current cytotoxic agents. Thus, significant opportunity
exists for new drugs that could synergize with existing cytotoxic
agents to reduce treatment and disease-related morbidity, and
improve treatment outcomes. XBiotech believes its new drug is
strongly positioned for this opportunity.
Cytotoxic chemotherapy agents result in systemic
toxicity—which is considered 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 may be a key player in the tumor
and treatment related inflammatory pathway.
XBiotech’s new drug XB2001 is a naturally
occurring antibody that potently neutralizes IL-1⍺ and is thus a
safe and promising approach to block inflammation that occurs with
advanced malignancies and chemotherapy. Unchecked, IL-1⍺ can
stimulate angiogenesis, enhancing blood and nutrient supply to the
tumor; IL-1⍺ 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-1⍺ can mediate metabolic dysfunction, and cause
fatigue, anorexia, and anxiety. IL-1⍺ is thus a central player in
paraneoplastic inflammation and XBiotech’s new drug therapy holds
promise for treating a wide array of cancers.
About True Human™ Therapeutic Antibodies
XBiotech’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 XBiotechXBiotech 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.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements, including declarations regarding management's beliefs
and expectations that involve substantial risks and uncertainties.
In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "would," "could,"
"expects," "plans," "contemplate," "anticipates," "believes,"
"estimates," "predicts," "projects," "intend" or "continue" or the
negative of such terms or other comparable terminology, although
not all forward-looking statements contain these identifying words.
Forward-looking statements are subject to inherent risks and
uncertainties in predicting future results and conditions that
could cause the actual results to differ materially from those
projected in these forward-looking statements. These risks and
uncertainties are subject to the disclosures set forth in the "Risk
Factors" section of certain of our SEC filings. Forward-looking
statements are not guarantees of future performance, and our actual
results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements that we make in this
press release speak only as of the date of this press release. We
assume no obligation to update our forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
ContactEmily
Simoneauesimoneau@xbiotech.comTel. 737-207-4606
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Mar 2024 to Apr 2024
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Apr 2023 to Apr 2024