BEVERLY HILLS, Calif.,
May 12, 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 provide an update concerning the
commencement of the GTB-3550 TriKE™ monotherapy Phase
2 clinical trial, and certain of its solid tumor targeting
TriKE™ product candidates.
Highlights to date from patients treated with GTB-3550
TriKE™ in the dose escalation Phase 1 clinical trial
for the treatment of high-risk myelodysplastic syndromes (MDS) and
refractory/relapsed acute myeloid leukemia (AML):
- Up to 63.7% Reduction in Bone Marrow Blast Levels seen in
some patients.
- Restoration of Patient's Endogenous NK Cell Function,
Proliferation and Immune Surveillance.
- No Progenitor-derived or Autologous/Allogenic Cell Therapy
Required.
- No Cytokine Release Syndrome Observed.
While the design of the Phase 1 part of the GTB-3550 clinical
trial was focused on evaluating safety, indications of anti-tumor
activity during Phase 1 have resulted in a refocusing of the Phase
2 design of the clinical trial towards enhancing efficacy,
durability of the clinical response, and overall survival with the
goal to seek accelerated approval from FDA. We intend to (i)
enroll patients with CD33 expression ≥50% in two independent
cohorts (higher-risk myelodysplastic syndrome and acute myeloid
leukemia); (ii) treat patients with two cycles of GTB-3550 therapy
with a rest period between cycles as opposed to the single-cycle
used during Phase 1; (iii) enroll patients with fewer prior
treatment lines; and, (iv) evaluate the potential use of minimal
residual disease (MRD) based endpoints that may allow for
accelerated approval.
Solid tumor cancers present a significantly larger market
opportunity than hematologic cancer indications, and represent the
majority of new cancer diagnoses annually. The Company is
presently advancing three TriKE™ product candidates in
GMP manufacturing and early clinical development. These solid
tumor TriKE product candidates will target cancers expressing HER2
(GTB-6550), PD-L1 (GTB-4550) and B7H3 (GTB-5550), and will be
evaluated for the treatment of multiple cancers such as breast,
lung, gastric, colorectal and ovarian. We believe GTB-3550
established the importance of incorporating IL-15 directly within
the TriKE protein biologic, providing NK cells with targeted
cytokine stimulation simultaneously with target-directed cancer
cell killing. We believe the selective expansion and
proliferation of the patient's endogenous NK cells coupled with
enhanced target-directed infiltration of activated NK cells into
the bone marrow resulting in significantly AML cancer blast killing
will translate to the solid tumor microenvironment.
"We believe GTB-3550 TriKE™ sets a new standard for
NK cell engager therapies due to the incorporation of interleukin
15 (IL-15) directly in the protein backbone," said Anthony J. Cataldo, GT Biopharma's Chairman and
Chief Executive Officer. "The flexibility and versatility of
our TriKE™ platform allows us to change the cancer
cell targeting mechanism of TriKE™ to attack different
cancers while maintaining the core NK cell activation,
proliferation and persistence attributes of the molecule," Mr.
Cataldo further stated.
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:
Institutional Investors:
Julie
Seidel
Stern Investor Relations, Inc.
Julie.seidel@sternir.com
212-362-1200
Investor
Relations:
Media Relations:
David
Castaneda Susan
Roush
David@gtbiopharma.com
Susan@gtbiopharma.com
414-351-9758 805-624-7624
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SOURCE GT Biopharma, Inc.