Deepening relationship between GT Biopharma and Dr.
Jeffrey Miller
TriKE™ improves FT538 iPSC NK cells from Fate Therapeutics
in prostate cancer model
GTB-3550 continues to demonstrate clinical success without
significant toxicities
BEVERLY HILLS, Calif.,
July 7, 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 it has entered into a sponsored
research agreement (SRA) with Jeffrey S.
Miller, M.D., Deputy Director of the University of Minnesota's Masonic Cancer Center and
Consulting Chief Scientific Officer of GT Biopharma.
The SRA is focused on supporting GT Biopharma's continued
clinical develop of TriKE™ therapeutic product candidates, and to
gain an increased understanding of changes in the patient's native
NK cell population as a result of TriKE™ therapy. The SRA is a
fixed sum contract worth Two Million Seventy-Four Thousand
Six Hundred Eighty-Six dollars
($2,074,686) payable over the next
two years in equal quarterly payments. GT Biopharma has early
termination rights without financial penalty, and will receive an
exclusive worldwide license to any patentable inventions which
arise under the SRA.
TriKE™ is a robust and versatile protein biologic therapeutic
platform which facilitates NK recognition and killing of cancer
cells. TriKE™ is a tri-specific recombinant protein biologic
composed of an NK cell engaging domain targeting CD16 on the NK
cell, an NK cell activating domain consisting Interleukin IL-15,
and a cancer cell targeting domain. The natural killer (NK)
cell-stimulating cytokine human IL-15 portion of the molecule
provides a self-sustaining signal that activates the patient's
endogenous, exhausted/inhibited NK cells enhancing their ability to
kill and proliferate without the need for the supplemental addition
of ex vivo engineered NK cells. TriKE™ does not require
costly or specialized manufacturing facilities nor is pretreatment
of the patient required prior to its administration. TriKE™ is also
significantly less expensive than iPSC NK cell therapies and
autologous/allogenic NK cell therapies.
Recently published data at the November
2020 meeting of the Society for Immunotherapy of Cancer
(SITC) by researchers at Fate Therapeutics and the University of Minnesota (see
https://jitc.bmj.com/content/8/Suppl_3/A287) demonstrates TriKE™ is
able to activate and target direct Fate Therapeutics' ex
vivo engineered iPSC NK cells (FT538), and turn those cells
into more effective killers resulting in the complete eradication
of the prostate cancer cells. Without the assistance of TriKE™, the
FT538 iPSC NK cells were unable to eradicate the prostate cancer
cells.
TriKE™ monotherapy has demonstrated in its first-in-class
clinical trial the ability to revive the patient's
exhausted/inhibited NK cells, significantly reduce cancer cell
numbers, and to do so without any toxicities including no cytokine
release syndrome (CRS). Highlights to date from patients treated
with GTB-3550 TriKE™ monotherapy in the dose escalation Phase 1
clinical trial for the treatment of high-risk MDS and
refractory/relapsed AML:
- 57% of patients experienced significant reduction in AML/MDS
cancer cell burden when treated with doses of GTB-3550 ranging from
25mcg/kg/day to 150mcg/kg/day.
- Up to 63.7% reduction in bone marrow blast levels observed
in some patients.
- GTB-3550 was well tolerated by all patients with no cytokine
release syndrome observed.
- Restoration of patient's endogenous NK cell function,
proliferation and immune surveillance observed in all patients – No
progenitor-derived or autologous/allogenic cell therapy
required.
"We have now completed treatment of eleven patients. In
addition to strong safety results, we have seen significant
reductions in CD33+ cancer cells," stated Anthony Cataldo, Chairman and Chief Executive
Officer of GT Biopharma. "We are pleased to sponsor additional
TriKE™ research in Dr. Miller's laboratory in support of our TriKE™
clinical development programs," Mr. Cataldo further stated.
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 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.
TriKE™ is a trademark of GT Biopharma, Inc.
Contacts:
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Institutional
Investors:
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Investor
Relations:
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Brendan
Payne
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David
Castaneda
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Stern Investor
Relations, Inc.
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David@gtbiopharma.com
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brendan.payne@sternir.com
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(414)
351-9758
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(212)
362-1200
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