Full Press Release Details
GT BIOPHARMA ANNOUNCES THE SALE OF ITS FIXED DOSE COMBINATION
TABLET (GTB-004) FOR MYASTHENIA GRAVIS (CHRONIC AUTOIMMUNE DISEASE)
Florida, September 24, 2019 / PRNewswire / -- GT Biopharma,
Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on
innovative treatments based on the Company's proprietary NK cell
engager (TriKE ) platform and Multi-Target Directed
Bispecific Drug Conjugate platform, announced today that it sold
the rights to GTB-004 for the treatment of myasthenia gravis to DAS
gravis is a chronic autoimmune disease of the neuromuscular
junction characterized by muscle weakness. The disease occurs in
all ethnic groups and both genders. The prevalence of the disease
in the United States is estimated at 14 to 20 per 100,000
population; approximately 36,000 to 60,000 cases in the U.S.
(Howard, 2015). Myasthenia gravis most commonly affects adult women
(onset between 20 to 40 years) and older men (onset over 60), but
it can occur at any age (Myasthenia Gravis Fact Sheet; National
Institute of Neurological Disorders and Stroke, 2016).
is a fixed-dose combination tablet for the treatment of the muscle
weakness associated with myasthenia gravis. GTB-004 combines
pyridostigmine with an antagonist helping to reduce
gastrointestinal side effects associated with pyridostigmine
the terms of the Asset Purchase Agreement, DAS Therapeutics
acquires all rights, title, clinical data, composition-of-matter
and use patents related to GTB-004. GT Biopharma will receive a
$200,000 up-front payment, annual royalties of 1.5% of Net Yearly
Sales, and a $6 million payment based on achievement of commercial
Anthony Cataldo, the Chairman and Chief Executive Officer of GT
Biopharma commented we are pleased that DAS Therapeutics
will continue to advance GTB-004 in a Phase II clinical trial and
toward product registration via the 505(b)(2) regulatory
path. Mr. Cataldo further stated we are gratified to
have been able to monetize part of our shareholders'
investment from our earlier acquisition of Georgetown Translational
Pharmaceuticals, Inc. a developer of central nervous
systems (CNS) targeted therapeutics. We will continue to remain
focused on our high value oncology assets, two of which are now in
FDA clinical trials.
gravis is a chronic autoimmune disease of the neuromuscular
junction characterized by muscle weakness. The disease occurs in
all ethnic groups and both genders. The prevalence of the disease
in the United States is estimated at 14 to 20 per 100,000
population; approximately 36,000 to 60,000 cases in the U.S.
(Howard, 2015). Myasthenia gravis most commonly affects adult women
(onset between 20 to 40 years) and older men (onset over 60), but
it can occur at any age (Myasthenia Gravis Fact Sheet; National
Institute of Neurological Disorders and Stroke, 2016).
About GTB-3550 Trispecific NK cell Engager
(OXS-3550) is the Company's first Tri-specific NK cell Engager
(TriKE ) product candidate being initially developed for the
treatment AML. GTB-3550 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. We intend to study GTB-3550 in CD33
positive leukemias such as acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS), and other CD33+ hematopoietic
About GTB-1550 Multi-Target Directed Bispecific Drug
targets cancer cells expressing the CD19 receptor or CD22 receptor
or both receptors thereby maximizing cancer cell recognition by
binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550
binds to cancer cells, the cancer cells internalize GTB-1550, and
are killed due to the action of drug's cytotoxic diphtheria toxin
About GT Biopharma, Inc.
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 Directed Bispecific Drug Conjugate
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 Directed
Bispecific Drug Conjugate platform can generate product candidates
that are bi-specific, ligand-directed single-chain fusion proteins
that, we believe, represent the next generation of targeted
Forward-Looking Statements
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 ,
estimates , expects ,
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 guarantees 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