Announced Positive Interim Data Results Demonstrating
Substantial Reduction in AML/MDS Cancer Cells and Bone Marrow Blast
Levels from GTB-3550 TriKE® Phase I Clinical Trial
Entered Research Agreement with Dr. Jeffrey S. Miller of the University of Minnesota for Further Development of
TriKE® Technology
Announced $16M Increase in
Cash from Warrant Exercise Proceeds
Management to Host Conference Call Today at 8:30 a.m. EST
BEVERLY HILLS, Calif.,
Aug. 13, 2021 /PRNewswire/ -- GT
Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a
clinical stage immuno-oncology company focused on developing
innovative therapeutics based on the Company's proprietary natural
killer (NK) cell engager (TriKE®) protein biologic
technology platform, today provided a general business update of
events in the second quarter ending June 30,
2021.
"I am pleased with the corporate and clinical development
milestones that GT Biopharma continues to achieve throughout the
first half of 2021," said Anthony J.
Cataldo, GT Biopharma's Chairman and Chief Executive
Officer. "The Company continues to demonstrate that our proprietary
TriKE® platform technology is both safe and efficacious,
demonstrated through our recent positive, interim data announcement
of our ongoing Phase I/II dose expansion clinical trial of GTB-3550
TriKE®. The TriKE® platform is robust,
focusing not only on hematologic cancers but also on solid tumor
cancers such as lung, prostate, breast and ovarian
cancers. The TriKE platform includes our B7H3, PD-L1 and HER2
TriKE® product candidates. Our breadth of
indications and the utility of TriKE® as a therapeutic
agent reduces the risk profile of our therapeutic platform and
pipeline. Our collaborative efforts were strengthened through
the Company's research agreement with Dr. Jeffrey S. Miller and the University of Minnesota, and signifies that we are
continuing to hit important strides in the clinic. These positive
milestones reinforce GT Biopharma's need to continue developing
this first-in-human treatment for patients living with AML, MDS and
other CD33+ hematologic cancers."
Clinical Highlights
- Reported Positive, Interim Data Results from First-in-Human
GTB-3550 TriKE® Phase I Clinical Trial for the Treatment
of Refractory/Relapsed Acute Myeloid Leukemia (AML) and High-Risk
Myelodysplastic Syndromes (MDS): In June
2021, GT Biopharma and Dr. Jeffrey
S. Miller presented positive, interim results from the Phase
I dose-escalation portion of the Phase I/II dose expansion clinical
trial of GTB-3550 TriKE® at the 2021 Raymond James Human
Health Innovation Conference. Results demonstrated that 57% of
patients achieved significant reduction in AML/MDS cancer cell
burden, with one patient reaching up to 63.7% reduction in bone
marrow blast levels. Across all patients, treatment of GTB-3550
TriKE® was well tolerated and no signs of cytokine
release syndrome (CRS) were detected. This portion of the Phase
I/II dose expansion trial is focused on determining the recommended
Phase II dose, the maximum tolerated dose (MTD), optimal dose
schedule, safety and tolerability of GTB-3550 TriKE®
administration. The Phase I safety study is expected to complete
later this fall and the Company has scheduled an interim data
publication for September 16-21, 2021
at the European Society for Medical Oncology Conference to be held
in Paris, France.
Corporate Highlights
- Announced Strategic Research Agreement with Dr. Jeffrey S. Miller of the University of Minnesota: In July 2021, GT Biopharma announced that it has
entered a research agreement with Dr. Jeffrey S. Miller, associated with the
University of Minnesota to further
develop the Company's proprietary TriKE® technology.
This agreement reinforces the clinical success that
TriKE® continues to demonstrate in patients with acute
myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
- Inclusion in the Russell 2000® Index: In
June 2021, GT Biopharma was added to
the Russel 2000® Index, signifying corporate and
clinical development milestones that the Company continues to
achieve. This listing enhances GT Biopharma's visibility to a
broader investment community, and increases long-term growth
potential as the Company continues to achieve important clinical
milestones associated with both their robust preclinical and
clinical pipelines.
- Announced $16M Cash Increase
from Warrant Exercise Proceeds: In July 2021, the Company announced a $16M increase in cash from exercised warrant
proceeds that were a part of the recent $27M financing completed in February of this
year. This capital will be used to further develop the
TriKE® technology in both preclinical and clinical
pipelines.
Conference Call
The Company will host a conference call at 8:30 a.m. EST today to provide a general business
update. To join the call U.S. callers should dial 1-877-870-4263
and international callers should dial 1-412-317-0790. All
participants should ask to be connected to the GT Biopharma
conference call.
A live webcast of the event will be available by visiting the
"Presentations" page in the Investors section of GT Biopharma's
website at www.gtbiopharma.com/news-media/presentations. A replay
of the webcast will be archived for 30 days following the
presentation.
About GTB-3550 TriKE®
GTB-3550 is the Company's first TriKE® product
candidate being initially developed for the treatment of acute
myeloid leukemia (AML), myelodysplastic syndromes (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 AML, 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 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's 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, filed with the Securities and
Exchange Commission (the "SEC") on April 16,
2021 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.
TriKE® is a registered trademark of GT Biopharma,
Inc.
Contact:
Institutional Investors:
Brendan Payne
Stern Investor Relations, Inc.
brendan.payne@sternir.com
212-362-1200
Investor & Media
Relations:
David
Castaneda
David@gtbiopharma.com
414-351-9758
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