GT BIOPHARMA ANNOUNCES UPDATE TO OXS-3550 IND FILING, ITS MOST ADVANCED TRI-SPECIFIC KILLER ENGAGER
May 16 2018 - 09:01AM
InvestorsHub NewsWire
Los Angeles, CA -- May 16, 2018 -- InvestorsHub NewsWire -- GT
Biopharma Inc. (OTCQB:
GTBP and Euronext Paris "GTBP.PA" or the “Company”), an
immuno-oncology biotechnology company focused on innovative
treatments based on the Company's proprietary platforms, has
reported that it expects to file the Investigational New Drug
Application (“IND”) for OXS-3550, the Company’s most advanced
Tri-specific Killer Engager (“TriKE”) product candidate, in
mid-2018.
GT Biopharma is working in collaboration with the Masonic Cancer
Center at the University of Minnesota under a program led by Dr.
Jeffrey Miller, Deputy Director. Dr. Miller is a recognized leader
in the field of Natural Killer (“NK”) cell and IL-15 biology and
their therapeutic potential.
“The expected filing of the IND for our first TriKE product
candidate in mid-2018 is representative of the overall progress we
are making as a company,” said Shawn M. Cross, Chairman and Chief
Executive Officer of GT Biopharma. “We look forward to updating our
shareholders on our progress throughout 2018 as we continue to
execute on our objectives.”
The IND for OXS-3550 was filed in June 2017 by the University of
Minnesota. Before the
IND was transferred to the Company in October 2017, the FDA
requested that additional preclinical toxicology be conducted prior
to initiating clinical trials. The FDA also requested additional
information and clarifications on the manufacturing (CMC) and
clinical packages. The Company has reported that the requested
additional information and clarifications have been completed and
are being incorporated into the IND in eCTD format and that it
expects to file the IND in mid-2018.
About GT Biopharma, Inc.
GT Biopharma, Inc. is an immuno-oncology biotechnology company
focused on innovative treatments based on the Company’s proprietary
Tri and Tetra-specific Natural Killer Cell Engagers (TriKEs™ and
TetraKEs) and bispecific antibody-drug conjugate (ADC) platforms.
GT's lead oncology drug candidate, OXS-1550 (DT2219) is a novel
bispecific scFv recombinant fusion protein-drug conjugate composed
of the variable regions of the heavy and light chains of anti-CD19
and anti-CD22 antibodies and a modified form of diphtheria toxin as
its cytotoxic drug payload. OXS-1550 has demonstrated success in
early human clinical trials in patients with relapsed/refractory
B-cell lymphoma or leukemia. In addition, GT's TriKE platform will
address a number of cancer types. GT's nervous system platform is
focused on acquiring or discovering and patenting late-stage,
de-risked, and close-to-market improved treatments for nervous
system diseases (Neurology and Pain) and shepherding them through
the approval process to the NDA. GT Biopharma's neurology products
currently include PainBrake, as well as treatments for the symptoms
of myasthenia gravis, and motion sickness.
Safe Harbor Statement
Except for historical information contained herein, the statements
in this release are forward-looking and made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are inherently unreliable and
actual results may differ materially. Examples of forward-looking
statements in this news release include statements regarding the
effectiveness of the Company's products, the potential outcome of
clinical studies, the potential outcome of the FDA regulatory
approval process, the future success of development activities and
the future growth and operating and financial performance of the
Company. Factors which could cause actual results to differ
materially from these forward-looking statements include such
factors as the Company's ability to accomplish its business
initiatives, obtain regulatory approval and protect its
intellectual property; significant fluctuations in marketing
expenses and ability to achieve or grow revenue, or recognize net
income, from the sale of its products and services, as well as the
introduction of competing products, or management's ability to
attract and maintain qualified personnel necessary for the
development and commercialization of its planned products, and
other information that may be detailed from time to time in the
Company's filings with the United States Securities and Exchange
Commission. The Company undertakes no obligation to publicly update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Contact:
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com