BEVERLY HILLS, Calif.,
June 23, 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, announced Jeffrey S. Miller, M.D., Deputy Director of the
Masonic Cancer Center and Consulting Chief Scientific Officer,
provided an update concerning GTB-3550 TriKE™
monotherapy clinical trial interim results at the 2021 Raymond
James Health Innovation Conference. The presentation will
be available on the "News & Media" page of the GT
Biopharma website at www.gtbiopharma.com/news-media/presentation.
Highlights to date from patients treated with GTB-3550
TriKE™ monotherapy in the dose escalation Phase 1
clinical trial for the treatment of high-risk MDS and
refractory/relapsed AML:
- 57% of patients experienced significant reduction in AML/MDS
cancer cell burden when treated with doses of GTB-3550 ranging from
25mcg/kg/day to 150mcg/kg/day.
- Up to 63.7% reduction in bone marrow blast levels observed
in some patients.
- GTB-3550 was well tolerated by all patients with no cytokine
release syndrome observed.
- Restoration of patient's endogenous NK cell function,
proliferation and immune surveillance observed in all patients – No
progenitor-derived or autologous/allogenic cell therapy
required.
The on-going Phase 1 clinical trial of GTB-3550
TriKE™ monotherapy is focused on evaluating safety,
and the determination of the recommended Phase 2 dose (RP2D), dose
schedule and the maximum tolerated dose (MTD). Additional
information is being collected concerning anti-tumor activity
against CD33+ acute myeloid leukemia (AML) and myelodysplastic
syndrome (MDS) cancer cells, and restoration of the patient's
exhausted/inhibited endogenous NK cell population. To date,
11 patients have completed treatment in the GTB-3550 Phase 1
clinical trial. Patient 5, Patient 7, Patient 9, Patient 11
experienced 33%, 61%, 63% and 50% reduction in CD33+ AML/MDS bone
marrow blast levels, respectively. The Phase 1 safety part of
the study is expected to conclude in late August 2021 with data publication currently
scheduled for end of September
2021.
"We continue to be pleased with the safety profile of GTB-3550,
and its ability to restore function of the patient's NK cells
without the need for the administration of ex vivo
engineered NK cells", said Anthony
Cataldo, GT Biopharma's Chairman and Chief Executive
Officer. "We have now completed treatment of eleven
patients. In addition to strong safety results, we have seen
significant reductions in CD33+ cancer cells in four of the last
seven patients (57%) treated with doses of GTB-3550 ranging from
25mcg/kg/day to 150mcg/kg/day. This early sign of CD33+
target-specific cancer cell killing is very encouraging as we begin
to focus on transitioning to the expanded efficacy part of the
current GTB-3550 clinical trial", 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:
Brendan Payne
Stern Investor Relations, Inc.
brendan.payne@sternir.com
Investor Relations:
David
Castaneda
David@gtbiopharma.com
(414) 351-9758
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SOURCE GT Biopharma, Inc.