Full Press Release Details
GT BIOPHARMA ANNOUNCES EXPANDED TRiKE PARTNERSHIP WITH CYTOVANCE
Sign $6,000,000.00 Agreement
BEVERLY HILLS, CALIFORNIA, October 6, 2020 / Accesswire /
-- GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) a company
focused on developing innovative therapeutic treatments based on
its proprietary NK cell engager (TriKE ) platform announced
today that it had entered into a partnership agreement with
Cytovance Biologics, a USA-based contract development and
manufacturing organization (CDMO) and a subsidiary of the Shenzhen
Hepalink Pharmaceutical Group Co., Ltd.
Under the terms of the partnership agreement, Cytovance will be the
exclusive GMP manufacture for three of the Company's
TriKE therapeutic product candidates. Cytovance will
manufacture TriKE in accordance with GMP using
Cytovance's proprietary Keystone bacterial or mammalian
expression systems. Subject to the completion of certain milestones
by Cytovance, GT Biopharma has the option to pay Cytovance up to $6
million for its manufacturing services in either cash or in shares
of the Company's common stock valued at the time Cytovance
achieves each of several milestones over the next 12
Matt Delaney, MBA, M.I.B., Vice President Business Development
& Marketing of Cytovance said we are pleased to have
been selected as GT Biopharma's exclusive GMP manufacturer
for its first three TriKE product candidates. Mr.
Delaney also stated we believe our proprietary
Keystone bacterial or mammalian expression systems will
deliver high production yields of TriKE further enhancing
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT
Biopharma commented we are pleased to have the opportunity
to expand our partnership with Cytovance. Mr. Cataldo
further stated the flexibility and breadth of our
TriKE therapeutic platform allows us to quickly adapt to new
disease targets, and rapidly advance TriKE product
opportunities into the clinic.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
and infectious disease therapeutic products based our proprietary
Tri-specific Killer Engager (TriKE ) platform. Our
TriKE platform is designed to harness and enhance the cancer
cell and virus infected cell killing using the patient's immune
system NK cells. GT Biopharma has an exclusive worldwide license
agreement with the University of Minnesota to further develop and
commercialize therapies using proprietary TriKE technology
developed by researchers at the university to target NK
About GTB-3550 TriKE FDA Clinical Trial
GTB-3550 is the Company's first TriKE product candidate
being initially developed for the treatment of acute myeloid
leukemia (AML). GTB-3550 is a tri-specific 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 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 are presently
evaluating GTB-3550 in a Phase I/II clinical trial
(ClinicalTrials.gov NCT03214666)
for the treatment of CD33 positive leukemias such as AML,
myelodysplastic syndrome and other CD33+ hematopoietic
About Cytovance Biologics
Cytovance Biologics is a leading biopharmaceutical Contract
Development and Manufacturing Organization (CDMO) that excels in
the rapid and cost-effective development and manufacture of large
molecule active pharmaceutical ingredients (APIs) from both
mammalian cell culture and microbial fermentation such as
monoclonal antibodies, fragment antibodies, bispecific antibodies,
enzymes, fusion proteins, vaccines, and other biological products
including plasmid DNA and cell-based therapeutics. In addition to
our clinical and commercial CGMP API manufacturing services,
Cytovance offers well-integrated development services supporting
the entire product lifecycle including cell line development, cell
banking, microbial strain development, process and analytical
development, and process characterization. A centralized,
responsive program management team coordinates all critical
chemistry, manufacturing and controls (CMC) activities for each
client program including technology transfer, development,
production, raw materials management, QC testing, ICH stability
studies, and regulatory support. Our 140,000 sq. ft.
state-of-the-art facilities in Oklahoma City are designed to meet
the U.S., EU, and other global regulatory standards.
About Cytovance Biologics Keystone Expression
The Keystone Expression
coli-based protein production
platform that combines industry leading DNA synthesis technologies
for gene and vector design (ATUM, Newark, CA) with
Cytovance's standard microbial platforms for cell substrate
development, fermentation, pilot, and CGMP manufacture with
standard analytics and a phase-appropriate CMC
Forward-Looking Statements
This press release contains certain forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 that involve risks, uncertainties and
assumptions that are difficult to predict, including statements
regarding the Company's expectations regarding the
development of GTB-3550 TriKE including its intended
therapeutic effect, and plans to conduct future clinical trials in
humans. Words and expressions reflecting optimism, satisfaction or
disappointment with current prospects, as well as words such as
outlook , believes ,
target , hopes , intends ,
estimates , expects ,