TAMPA, Florida, June 13, 2019 /PRNewswire/ -- GT Biopharma, Inc.
(OTCQB: GTBP) (GTBP.PA) an immuno-oncology company developing
GTB-1550, a novel multi-target bispecific drug conjugate therapy
for the treatment of chemotherapy-refractory B-cell
malignancies.
Today, Bloomberg discussed antibody-drug conjugates (ADC) as
effective cancer therapies having the potential to replace
traditional chemotherapy. ADCs are essentially a "trojan horse"
therapeutics which have several advantages over traditional
chemotherapy including less toxicity and higher efficacy due to a
more precise targeting of cancer cells compared to non-cancer
cells.
An ADC is composed of an antibody which specifically identifies
cancer cells and a cytotoxic agent (the payload) which has been
grafted onto the antibody. When injected into patients, the
ADC traffics through the patient's body to find the targeted cancer
cells. Upon binding to the cancer cell, the ADC is
internalized by the cancer cell, and the cytotoxic payload kills
the cancer cell.
Anthony Cataldo (CEO GT
Biopharma, Inc.) said, "The Bloomberg article points out the
excitement that big pharma is now realizing as the potential for
ADC's as a realistic alternative to Chemo Therapies. What
differentiates our ADC Bispecific GTB-1550, is the ability for our
drug to hit multiple target sites of B-cell malignancies as opposed
to the one target ADC's represented in the Bloomberg article. We
are happy to see the attention of the large pharmaceuticals moving
in this direction."
GTB-1550 is a novel, multi-target bispecific cytotoxic
therapeutic agent consisting of diphtheria toxin and bispecific
single-chain variable fragments (scFV) of antibodies targeting
human CD19 and CD22. By simultaneously targeting cancer cells
that express either CD19 or CD22 or both, GTB-1550 is capable of
killing a broader variety of hematological malignancies than either
a traditional a CD19 antibody drug conjugate or a CD19 CAR-T
immunotherapy which are only able to target and attack CD19
expressing hematological malignancies. Simultaneously
targeting multiple cancer targets such as CD19 and CD22 using a
single therapeutic agent potentially makes GT Biopharma's
multi-target bispecific drug conjugate therapy the next generation
of advanced cancer therapies.
To date, GTB-1550 has completed one dose escalation Phase I-II
expansion clinical trial, and one fixed dose Phase I-II expansion
clinical trial which collectively enrolled a combined 43
patients.
Top-line Consolidated Results:
- Two patients exhibited a Complete Remission (CR) with one
patient currently disease-free at 50 months post treatment.
- Five patients exhibited Stable Disease (SD) with the longest
response lasting 12 months post treatment.
- Two patients with transformed lymphoma showed transient tumor
shrinkage, however, therapy was discontinued due to dose-limiting
toxicities after the 1st cycle.
- Greater than 50% of evaluable patients receiving 60 mg/kg dose
had positive clinical response defined as stable disease, partial
remission, or complete remission.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
products based off our proprietary Tri-specific Killer Engager
(TriKE) and Multi-Target Bispecific Drug Conjugate (MTBDC)
technology platforms. 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 cancer therapies using proprietary TriKE technology
developed by researchers at the university to target NK cells to
cancer. Our Multi-Target Bispecific Drug Conjugate (MTBDC)
platform can generate product candidates that are bispecific,
ligand-directed single-chain fusion proteins that, we believe,
represent the next generation of targeted therapy.
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, 2018 in the section titled "Risk Factors" in Part
I, Item 1A and in our subsequent 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
for GTB-3550 or GTB-1550, 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.
+1-800-304-9888
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SOURCE GT Biopharma, Inc.