BEVERLY Hills, Calif.,
May 18, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP) a clinical stage biopharmaceutical
company focused on the development and commercialization of
disruptive, target-directed Natural Killer (NK) cell engager
immunotherapy protein biologic platform technology,
TriKE™, for the treatment of cancer and infectious
diseases, today announced that it will be hosting a call with Dr.
Jeffrey S. Miller and GT Biopharma
on Wednesday, May
19th at 4:00 PM Eastern Time.
Interim GTB-3550 TriKE™ Data
Clinical Highlights
- Updated Interim Results from First-in-Human GTB-3550 TriKE™
Phase I/II Clinical Trial for the Treatment of High-Risk
Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute
Myeloid Leukemia (AML): Results demonstrated up to 63.7%
reduction in bone marrow blast levels, and restoration of
endogenous NK cell function, proliferation and immune surveillance
without combination ex vivo supplemental NK cell therapy.
All patients treated displayed no signs of any grade of cytokine
release syndrome (CRS) across all dose cohorts. GTB-3550 TriKE™ is
currently being administered to patients at doses significantly
higher than the reported maximum tolerated dose (MTD) for
continuous infusion of recombinant human interleukin-15
(IL-15).
- Enrollment in Phase I Portion of GTB-3550 TriKE™ Phase I/II
Clinical Trial in MDS and AML Continues: GTB-3550 TriKE™ Phase
I/II Clinical Trial in high-risk MDS and AML patients continues to
enroll patients. Patient 11 began treatment dosed at
150mcg/kg/day.
- New Findings Supporting GTB-3550 TriKE™ Monotherapy:
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.
- Preliminary Phase II Clinical Trial Design: The Phase II
expansion part of the current GTB-3550 clinical trial intends to
enroll patients with CD33 expression ≥50% in independent cohorts
(higher-risk MDS and AML); 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; enroll patients with fewer
prior treatment lines; and, evaluate the potential use of minimal
residual disease (MRD) based endpoints that may allow for
accelerated approval.
A live webcast of the presentation may be accessed by visiting
https://www.webcaster4.com/Webcast/Page/4/41418 as well as from the
Investors section of the GT Biopharma website at
https://ir.gtbiopharma.com/.
Those who wish to dial in for the audio portion only of the
event an audio only may do so at:
PARTICIPANT DIAL-IN (TOLL FREE): -
1-877-870-4263
PARTICIPANT INTERNATIONAL DIAL IN:
1-412-317-0790
Canada Toll Free:
1-855-669-9657
Please ask to be joined into the GT
Biopharma call.
An archived replay of the webcast will be available on the
Company's website by visiting:
https://services.choruscall.com/ccforms/replay.html
Replay Access Code:
10156826
About GTB-3550 TriKE™
GTB-3550 TriKE™ is a first-in-class immuno-oncology therapeutic
being evaluated in patients age 18 and older in a Phase I/II
clinical trial (NCT03214666) having CD33+ malignancies (primary
induction failure or relapsed AML with failure of one reinduction
attempt or high-risk MDS progressed on two lines of therapy).
Interim results demonstrated GTB-3550 TriKE™ reduces bone marrow
blast levels in AML and MDS patients, and improved NK cell function
and proliferation.
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.
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.
For more information, please visit www.gtbiopharma.com.
Investors:
Julie Seidel
Stern Investor Relations, Inc.
Julie.seidel@sternir.com
212-362-1200
David Castaneda
David@gtbiopharma.com
414-351-9758
Media Relations:
Susan Roush
Susan@gtbiopharma.com
805-624-7624
View original content to download
multimedia:http://www.prnewswire.com/news-releases/gt-biopharma-to-host-interim-gtb-3550-trike-data-review-call-with-dr-jeffrey-s-miller-on-may-19-2021-at-400-pm-et-301293882.html
SOURCE GT Biopharma, Inc.