POTENTIAL TREATMENT OF SEVERAL SOLID TUMOR CANCERS
INCLUDING: NON-SMALL CELL LUNG CANCER, SQUAMOUS CELL CARNINOMA,
BREAST CANCER, RENAL CANCER, PANCREATIC CANCER, OVARIAN CANCER,
LIVER CANCER, COLORECTAL CANCER
BEVERLY
HILLS, Calif., Aug. 3,
2021 /PRNewswire/ -- GT Biopharma, Inc. (NASDAQ: GTBP),
a clinical stage biopharmaceutical company focused on developing
target-directed, tri-specific Natural Killer (NK) cell engager
therapies (TriKE™) incorporating interleukin 15 (IL-15) for the
treatment of cancer, announced preclinical results for GTB-5550,
its B7H3 TriKE™ product candidate as a prospective therapy for the
treatment of several different types of cancers.
GTB-5550 TriKE™ was evaluated in several preclinical models
overexpressing B7H3, and was found to be effective at promoting NK
cell killing of multiple cancer cell types. B7H3 is
over-expressed on several cancer types including non-small cell
lung cancer, squamous cell carcinoma, and breast, renal,
pancreatic, ovarian, liver and colorectal cancers. GTB-5550
TriKE™ is presently undergoing GMP manufacturing scale-up in
preparation for filing an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA) for
evaluation in humans.
B7H3 is a member of the B7 family of immune checkpoint
inhibitors which includes PD-1/PD-L1 and CTLA-4/CD80. Merck's
Keytruda® (pembrolizumab) and Bristol-Myer Squibb's YERVOY®
(ipilimumab) targeting the PD-1/PD-L1 and CTLA-4/CD-80 checkpoints,
respectively, have demonstrated significant survival benefit and
are blockbuster immune-oncology therapeutics.
B7H3 expression on cancer cells is highly associated with
undesirable treatment outcomes and survival time. Targeting
B7H3 on cancer cells with TriKE™ and redirecting NK cells to attack
and kill cancer cells expressing B7H3, could result in a
therapeutic treatment that limits the metastatic potential and
invasiveness of certain solid tumor cancers.
Anthony J. Cataldo, GT
Biopharma's Chairman and Chief Executive Officer, commented: "We
are pleased to report our GTB-5550 TriKE™ has passed this important
development milestone, and demonstrated effectiveness in promoting
redirected and target-specific killing by NK cells."
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
therapeutic products based our proprietary TriKE™ NK cell engager
platform. The TriKE™ platform is designed to activate and
redirect the target cell killing abilities of the patient's natural
killer cells (NK cells) without the need for supplemental ex
vivo engineered donor or autologous NK cells, or induced
pluripotent stem cells (iPSC). The Company has an exclusive
worldwide license agreement with the University of Minnesota to further develop and
commercialize therapies using TriKE™ technology. GT
Biopharma's lead TriKE™ product candidate, GTB-3550 TriKE™, is
being evaluated in a multicenter Phase I/II trial
(ClinicalTrials.gov NCT03214666) for the treatment of acute myeloid
leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+
hematopoietic malignancies.
Forward-Looking Statements
This press release contains certain forward-looking statements
that involve risks, uncertainties and assumptions that are
difficult to predict, including statements regarding the potential
acquisition, the likelihood of closing the potential transaction,
our clinical focus, and our current and proposed trials.
Words and expressions reflecting optimism, satisfaction or
disappointment with current prospects, as well as words such as
"believes", "hopes", "intends", "estimates", "expects", "projects",
"plans", "anticipates" and variations thereof, or the use of future
tense, identify forward-looking statements, but their absence does
not mean that a statement is not forward-looking. Our
forward-looking statements are not a guarantee of performance, and
actual results could differ materially from those contained in or
expressed by such statements. In evaluating all such
statements, we urge you to specifically consider the various risk
factors identified in our Form 10-K for the fiscal year ended
December 31, 2020 in the section titled "Risk Factors" in Part
I, Item 1A and in our subsequent Form 10Q Quarterly filings with
the Securities and Exchange Commission, any of which could cause
actual results to differ materially from those indicated by our
forward-looking statements.
Our forward-looking statements reflect our current views with
respect to future events and are based on currently available
financial, economic, scientific, and competitive data and
information on current business plans. You should not place
undue reliance on our forward-looking statements, which are subject
to risks and uncertainties relating to, among other things:
(i) the sufficiency of our cash position and our ongoing
ability to raise additional capital to fund our operations,
(ii) our ability to complete our contemplated clinical trials,
or to meet the FDA's requirements with respect to safety and
efficacy, (iii) our ability to identify patients to enroll in our
clinical trials in a timely fashion, (iv) our ability to
achieve approval of a marketable product, (v) design,
implementation and conduct of clinical trials, (vii) the
results of our clinical trials, including the possibility of
unfavorable clinical trial results, (vii) the market for, and
marketability of, any product that is approved, (viii) the
existence or development of treatments that are viewed by medical
professionals or patients as superior to our products,
(ix) regulatory initiatives, compliance with governmental
regulations and the regulatory approval process, and social
conditions, and (x) various other matters, many of which are
beyond our control. Should one or more of these risks or
uncertainties develop, or should underlying assumptions prove to be
incorrect, actual results may vary materially and adversely from
those anticipated, believed, estimated, or otherwise indicated by
our forward-looking statements.
We intend that all forward-looking statements made in this press
release will be subject to the safe harbor protection of the
federal securities laws pursuant to Section 27A of the
Securities Act, to the extent applicable. Except as required
by law, we do not undertake any responsibility to update these
forward-looking statements to take into account events or
circumstances that occur after the date of this press
release. Additionally, we do not undertake any responsibility
to update you on the occurrence of any unanticipated events which
may cause actual results to differ from those expressed or implied
by these forward-looking statements.
TriKE™ is a trademark of GT Biopharma, Inc.
Keytruda® is a registered trademark of Merck and Co., Inc.
YERVOY® is a registered trademark of Bristol-Myer Squibb, Inc.
For more information, please visit www.gtbiopharma.com.
Contact:
Investor & Media Relations:
David Castaneda
David@gtbiopharma.com
414-351-9758
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