BEVERLY HILLS, Calif.,
Feb. 18, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical
company focused on the development and commercialization of its
disruptive, target-directed Natural Killer (NK) cell engager
immunotherapy protein biologic platform technology: TriKE™ for
cancer and infectious diseases, today announced it has signed an
expanded GMP manufacturing agreement with Cytovance Biologics for
the manufacture of all TriKEs™. Previously, the lead candidate
GTB-3550 TriKE™ was manufactured at the University of Minnesota's GMP manufacturing center,
following its invention and development at the institution by GT
Biopharma's Consulting Chief Medical Officer, Jeffrey S. Miller, M.D.
Anthony J. Cataldo, GT
Biopharma's Chairman and Chief Executive Officer, commented: "This
move positions the Company for large-scale commercial manufacturing
in anticipation of an expanded GTB-3550 TriKE™ Phase 1/2
for Acute Myeloid Leukemia (AML) and Myelodysplastic syndromes
(MDS). We are pleased with the work and dedication of our
manufacturing partner, Cytovance Biologics, and look forward to
progressing our solid tumor TriKEs™ (PD-L1, B7H3 and Herc 2), which
represent the largest portion of the cancer market, last quarter to
early first quarter next year. This expanded manufacturing
capability positions us to initiate the process of additional
clinical trials expected in early 2022."
About GTB-3550 TriKE™
GTB-3550 TriKE™ is the Company's first TriKE™ product
candidate being initially developed for the treatment of acute
myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other
CD33+ hematopoietic malignancies. GTB-3550 TriKE™ 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
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 cancer
cells and amplify the body's native immune system's NK cells.
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. Interim results presented at the
American Society of Hematology meeting December 5, 2020 demonstrates GTB-3550 TriKE™
reduces bone marrow blast levels in AML and MDS patients with
reported no toxicities, and improves 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 immunology
therapeutic products based on our proprietary Trispecific Killer
Engagers (TriKE™) target-directed Natural Killer (NK) cell engager
platform. The TriKE™ NK protein biologic platform is designed to
harness and amplify the body's native immune system for hope
for patients with cancer and infectious diseases. GT Biopharma has
an exclusive worldwide license agreement with the University of Minnesota, where Jeffery S. Miller, M.D., GT Biopharma's
Consulting Chief Medical Officer, developed the TriKE™, to further
develop and commercialize therapies using TriKE™ technology. For
further information, please
visit http://www.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, 2019 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.
Contact:
Andrew Barwicki
516-662-9461 / Andrew@barwicki.com
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SOURCE GT Biopharma, Inc.