BEVERLY HILLS, Calif.,
April 8, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology
company focused on developing innovative therapeutics based on the
Company's proprietary NK cell engager (TriKE™) protein biologic
technology platform, is pleased to announce the enrollment of
Patient 10 in its GTB-3550 TriKE™ first-in-human Phase I/II
clinical trial for the treatment of high-risk myelodysplastic
syndromes (MDS) and refractory/relapsed acute myeloid leukemia
(AML). Patient 10 will be dosed at 100mcg/kg/day.
Highlights from the first nine patients treated with GTB-3550
TriKE™ include:
- Up to 63.7% Reduction in Bone Marrow Blast Levels
- Restores Patient's Endogenous NK Cell Function,
Proliferation and Immune Surveillance
- No Progenitor-derived or Autologous/Allogenic Cell Therapy
Required
- No Cytokine Release Syndrome Observed
- 3 out of the Last 5 Patients Treated (25mcg/kg/day to
100mcg/kg/day) Respond
"We are pleased with the continued clinical performance of our
lead TriKE™ product candidate, and in reaching this important
patient enrollment milestone," said Anthony
J. Cataldo, GT Biopharma's Chairman and Chief Executive
Officer. "The data from the first nine patients treated with
GTB-3550 indicates significant bone marrow blast level reductions
in AML and MDS patients without the need for expensive
progenitor-derived or autologous/allogenic cell
therapies."
About High-Risk Myelodysplastic Syndromes
MDS is a
rare form of bone marrow-related cancer caused by irregular blood
cell production within the bone marrow. As a result of this
irregular production, MDS patients do not have sufficient normal
red blood cells, white blood cells and/or platelets in circulation.
High-risk MDS is associated with poor prognosis, diminished quality
of life, and a higher chance of transformation to acute myeloid
leukemia. Approximately 40% of patients with High-Risk MDS
transform to AML, another aggressive cancer with poor outcomes.
About Acute Myeloid Leukemia
Acute myeloid leukemia is
a type of cancer in which the bone marrow makes abnormal
myeloblasts (a type of white blood cell), red blood cells, or
platelets. According to the National Cancer Institute (NCI),
the five-year survival rate is about 35% in people under 60 years
old, and 10% in people over 60 years old. Older people whose
health is too poor for intensive chemotherapy have a typical
survival of five to ten months. AML accounts for roughly 1.8%
of cancer deaths in the United
States.
About GTB-3550 TriKE™
GTB-3550 is the Company's first
TriKE™ product candidate being initially developed for the
treatment of AML and MDS, and other CD33+ hematologic cancers.
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 Interleukin 15 (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 intend to study GTB-3550 in
CD33 positive leukemias such as acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and other CD33+ hematopoietic
malignancies.
About GTB-3550 TriKE™ Clinical Trial
Patients with
CD33+ malignancies (primary induction failure or relapsed AML with
failure of one reinduction attempt or high-risk MDS progressed on
two lines of therapy) age 18 and older are eligible (NCT03214666).
The primary endpoint is to identify the maximum tolerated dose
(MTD) of GTB-3550 TriKE™. Correlative objectives include the
number, phenotype, activation status and function of NK cells and T
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. Our TriKE™
platform is designed to harness and enhance the cancer killing
abilities of a patient's immune system natural killer cells (NK
cells). GT Biopharma has an exclusive worldwide license agreement
with the University of Minnesota to
further develop and commercialize therapies using TriKE™
technology. For more information, please visit 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, 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.
Contacts:
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Institutional
Investors:
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Julie
Seidel
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Stern Investor
Relations, Inc.
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Julie.seidel@sternir.com
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212-362-1200
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Investor
Relations:
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Media
Relations:
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David
Castaneda
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Susan
Roush
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David@gtbiopharma.com
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Susan@gtbiopharma.com
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414-351-9758
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805-624-7624
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SOURCE GT Biopharma, Inc.