BEVERLY HILLS, Calif.,
April 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, announced today
additional interim results from 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).
Additional results show GTB-3550 TriKE™ monotherapy is able to
rescue the patient's otherwise exhausted/inhibited/non-functional
endogenous NK cell population and target direct killing of the
patient's AML and MDS cancer cells without the need for the
co-administration addition of supplemental progenitor-derived or
autologous/allogenic engineered NK cells.
GTB-3550 TriKE™ monotherapy has demonstrated clinical benefit in
very hard to treat relapsed/refractory AML and high-risk MDS cancer
patients by significantly reducing cancer cell (blast) levels and,
in some cases, ending transfusion dependency with patients becoming
eligible for bone marrow transplant.
The ability to use GTB-3550 in a monotherapy setting is a
significant competitive and therapeutic advantage, and a major cost
savings compared to the co-administration of drug/cell therapy
combination regimens. GTB-3550 TriKE™ therapy requires no
patient pre-treatment regimens such as myeloablative chemotherapy,
and is well tolerated with no signs of cytokine release syndrome
(CRS) or other toxicities suggesting GTB-3550 could be used to
treat patients earlier in the disease process, whereas complicated
and expensive combination drug/cell therapy regimens are expected
to be used as late-stage or salvage therapies after all other
therapeutic options have been exhausted.
Highlights from the first nine patients treated with GTB-3550
TriKE™ include:
- Up to 63.7% Reduction in Bone Marrow Blast Levels Resulting
in Clinical Benefit
- 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 Respond (25mcg/kg/day
to 100mcg/kg/day therapeutic dose range)
"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. The flexibility and
versatility of our TriKE™ platform allows us to change the cancer
cell targeting moiety of TriKE™ to attack different cancers while
maintaining the core NK cell activation, proliferation and
persistence attributes of the molecule," said Anthony J. Cataldo, GT Biopharma's Chairman and
Chief Executive Officer. "The TriKE™ is a true
monotherapy, unlike all other NK cell technologies in
development. The novel TriKE™ uniquely does not need any
outside NK cell manufacturing or combination drugs, to supplement
or assist. Further, the TriKE™ does not require pre-conditioning of
the patient's immune system. These supplemental requirements of
competitive technologies add tremendous cost to an already costly
therapeutic approach. Everything the TriKE™ does happens with no
outside assistance whatsoever. We believe the TriKE's clinical data
is demonstrating exactly that, opening the door to a significantly
more cost-effective off-the-shelf therapeutic."
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
on 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.