BEVERLY HILLS, Calif.,
March 4, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical
company focused on the development and commercialization of its
disruptive, target-directed Natural Killer (NK) cell engager
immunotherapy protein biologic platform technology: TriKE™ for
cancer and infectious diseases, today announced the addition of a
new clinical trial site for its ongoing GTB-3550 TriKE™ multicenter
Phase I/II trial (ClinicalTrials.gov NCT03214666). The University of Wisconsin – Madison Carbone Cancer
Center will serve as the second site for this program, with
Kalyan Vara Ganesh Nadiminti M.D.,
UW Assistant Professor in Hematology, Oncology and Palliative Care,
serving as lead investigator. Dr. Nadiminti will be working closely
with Jeffery S. Miller, M.D., GT
Biopharma's Consulting Chief Medical Officer and developer of
TriKE™ and the trial design, and Erica
Warlick, M.D., Principal Investigator, both of the
University of Minnesota. UM's Masonic
Cancer Center is the initial site of the GTB-3550 TriKE™ Phase 1/2
trial.
Anthony J. Cataldo, GT
Biopharma's Chairman and Chief Executive Officer, commented: "It is
exciting to announce the addition of a second clinical trial site
for our Phase I/II program of our novel GTB-3550 TriKE™ program.
With this progress, we are closer to bringing our disruptive and
target-directed NK cell engager approach to patients in need. We
are grateful to the valiant patients and their families, as we
continue to progress this initial indication trial of our
first-in-class NK cell protein biologic cancer therapy."
GTB-3550 TriKE™ is being evaluated in patients age 18 and older
with CD33+ malignancies (primary induction failure or relapsed
acute myeloid leukemia [AML] with failure of one reinduction
attempt, or high-risk myelodysplastic syndromes [MDS] progressed on
two lines of therapy). The primary endpoint is to identify the
maximum tolerated dose and safety of GTB-3550 TriKE™ therapy.
Correlative objectives include the number, phenotype, activation
status and function of NK cells and T cells. Interim results
presented at the American Society of Hematology meeting on
December 5, 2020 demonstrates
GTB-3550 TriKE™ reduces bone marrow blast levels in AML and MDS
patients with reported no toxicities, and improves NK cell function
and proliferation.
About GTB-3550 TriKE™
GTB-3550 is the Company's first TriKE™ product candidate being
initially developed for the treatment AML. GTB-3550 is a
single-chain, tri-specific scFv recombinant fusion protein
conjugate composed of the variable regions of the heavy and light
chains of anti-CD16 and anti-CD33 antibodies and a modified form of
IL-15. The natural killer (NK) cell stimulating cytokine
human IL-15 portion of the molecule provides a self-sustaining
signal that activates NK cells and enhances their ability to
kill. We are evaluating GTB-3550 TriKE™ in a Phase I/II
clinical trial for the treatment of acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and other CD33+ hematopoietic
malignancies.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immunology
therapeutic products based on our proprietary Trispecific Killer
Engagers (TriKE™) target-directed Natural Killer (NK) cell engager
platform. The TriKE™ NK protein biologic platform is designed to
harness and amplify the body's native immune system for hope
for patients with cancer and infectious diseases. GT Biopharma has
an exclusive worldwide license agreement with the University of Minnesota, where Jeffery S. Miller, M.D., GT Biopharma's
Consulting Chief Medical Officer, developed the TriKE™, to further
develop and commercialize therapies using TriKE™ technology. For
further information, please
visit http://www.gtbiopharma.com.
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, 2019 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.
For more information, please visit www.gtbiopharma.com.
Contact:
Investor Relations
David Castaneda
David@gtbiopharma.com
414-351-9758
Media Relations
Susan Roush
Susan@gtbiopharma.com
805-624-7624
Institutional Investors
Julie Seidel
Stern Investor Relations, Inc.
Julie.seidel@sternir.com
212-362-1200
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SOURCE GT Biopharma, Inc.