BEVERLY HILLS, Calif.,
March 8, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical
company focused on disruptive, target-directed Natural Killer (NK)
cell engager immunotherapy technologies (TriKE™) for cancer,
announces preclinical results for its ROR1 TriKE™ product candidate
as a prospective therapy for the treatment of prostate cancer.
Tyrosine kinase transmembrane receptor ROR1 has recently been
shown to be overexpressed on certain cancer cells, and appears to
play a functional role in promoting migration/invasion and
influencing the metastatic potential of various solid tumor
cancers. Targeting ROR1 on cancer cells with TriKE™ and redirecting
NK cells to attack and kill cancer cells expressing ROR1, could
result in a therapeutic treatment that limits the metastatic
potential and invasiveness of certain solid tumor cancers.
The ROR1 TriKE™ was evaluated in several preclinical models of
prostate cancer, and was found to be effective at promoting NK cell
killing of multiple prostate cancer cells including LnCAP, C4-2,
PC-3, DU-145, VCaP and 22RV1. Significant NK cell activation and
interferon gamma (IFNγ) production was also observed as a result of
TriKE™ engagement and activation of the NK cell.
"We are pleased to report our ROR1 TriKE™ has passed this
important preclinical milestone, and demonstrated effectiveness in
promoting redirected and target-specific killing by NK cells," said
Anthony J. Cataldo, GT Biopharma's
Chairman and Chief Executive Officer. "We plan to evaluate the ROR1
TriKE™ in additional IND-enabling preclinical studies with the goal
of transitioning to a Phase I/II clinical trial."
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. The TriKE™ platform is designed to activate and
redirect the target cell killing abilities of the patient's natural
killer cells (NK cells) without the need for supplemental ex
vivo engineered donor or autologous NK cells, or induced
pluripotent stem cells (iPSC). The Company has an exclusive
worldwide license agreement with the University of Minnesota to further develop and
commercialize therapies using TriKE™ technology. GT Biopharma's
lead TriKE™ product candidate, GTB-3550 TriKE™, is being
evaluated in a multicenter Phase I/II trial (ClinicalTrials.gov
NCT03214666) for the treatment of acute myeloid leukemia
(AML), myelodysplastic syndrome (MDS), and other CD33+
hematopoietic malignancies.
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.
Contact:
Institutional Investors:
Julie
Seidel
Stern Investor Relations, Inc.
Julie.seidel@sternir.com
212-362-1200
Investor Relations:
David
Castaneda
David@gtbiopharma.com
414-351-9758
Media Relations:
Susan Roush
Susan@gtbiopharma.com
805-624-7624
View original
content:http://www.prnewswire.com/news-releases/gt-biopharma-announces-preclinical-results-for-its-ror1-trike-as-a-treatment-for-prostate-cancer-301242002.html
SOURCE GT Biopharma, Inc.