Full Press Release Details
GT Biopharma Reports Third Quarter 2018 Financial Results and
Provides Business Update
Recent corporate, preclinical, clinical and regulatory
advancements expected to position Company for a transformational
FDA clearance of IND to advance first-in-class TriKE,
GTB-3550, into first-in-human Phase 1 study for the treatment of
AML, MDS and mastocytosis marks significant regulatory
Continued progress of Phase 2a study of GTB-1550 with
topline results expected in Q1 2019
LOS ANGELES, CA (November 15, 2018)
Biopharma, Inc. (OTCQB: GTBP and Euronext Paris GTBP.PA)
("GT Biopharma" or the "Company"), an immuno-oncology biotechnology
company focused on innovative treatments based on the Company's
proprietary NK-engager and Bispecific Antibody Drug Conjugate
platforms, announced today its financial results for the third
quarter ended September 30, 2018.
Company also provided an update on its corporate progress, clinical
status and anticipated milestones for its pipeline of
immuno-oncology products based off the Company's proprietary
Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager
(TetraKE) and bi-specific Antibody Drug Conjugate (ADC) technology
Recent Corporate Highlights:
clearance to commence first-in-human Phase 1 study of
first-in-class TriKE, GTB-3550 (OXS-3550), for the treatment of
acute myelogenous leukemia, myelodysplatic syndrome and
preclinical data for two next generation TriKEs in ovarian and head
and neck cancers. The studies were conducted by Dr. Daniel Vallera,
Director, Section of Molecular Cancer Therapeutics and Dr. Martin
Felices, Co-Director of the Translational Therapy Laboratory at the
Masonic Cancer Center, University of Minnesota.
with major pharmaceutical company and initiated preclinical combination trial of
GTB-1550 (OXS-1550) and multi-billion dollar oncology drug for
testing in several hematologic malignancies.
leadership team with appointments of Dr. Raymond W. Urbanski M.D.,
Ph.D. as CEO and Chairman of the Board (formerly Chief Medical
Officer of the Company); well-respected industry veteran, Dr. John N. Bonfiglio as a new
independent Board Member and David Cardino, CPA, as VP,
have made significant progress in building a solid foundation for
the Company in what we believe is an important transitional phase
for GT Biopharma. The additions and changes to the leadership team
and execution of key preclinical, clinical and regulatory
milestones are a testament to this progress, commented
Urbanski, M.D., Ph.D., Chief Executive Officer of GT
Biopharma. However, as we navigate through this phase, we
certainly face challenges, including ensuring we are properly
funded and have the right team in place to propel the Company to
our next phase of growth. Successfully completing a financing and
bolstering our management team and Board in the near term remains a
priority. I, along with our Board, believe GT Biopharma has a
first-in-class platform technology and the potential to provide
revolutionary advancements in the treatment of various cancers
where there remains significant unmet need. We are committed to
securing the necessary capital to continue to aggressively execute
on our strategy and advance our development programs to drive
significant shareholder value. I believe we are taking the
necessary steps to position GT Biopharma for a transformational
Clinical Program Updates
Company's TriKE product candidates are single-chain,
tri-specific scFv recombinant fusion proteins composed of the
variable regions of the heavy and light chains (or heavy chain
only) of anti-CD16 antibodies, wild-type or a modified form of
IL-15 and the variable regions of the heavy and light chains of an
antibody designed to precisely target a specific tumor antigen. GT
Biopharma utilizes the NK stimulating cytokine human IL-15 as a
crosslinker between the two scFvs which is designed to provide a
self-sustaining signal leading to the proliferation and activation
of NK cells thus enhancing their ability to kill cancer cells
mediated by antibody-dependent cell-mediated cytotoxicity
Company's TetraKE product candidates are single-chain fusion
proteins composed of human single-domain anti-CD16 antibody,
wild-type IL-15 and the variable regions of the heavy and light
chains of two antibodies that are designed to target two specific
tumor antigens expressed on specific types of cancer
Biopharma's TriKEs and TetraKEs are designed to act by
binding to a patient's NK cells and a specific tumor antigen
enabling an immune synapse between the now IL-15-enhanced NK cell
and the targeted cancer cell. The formation of an immune synapse
can induce NK cell activation which can lead to the death of the
cancer cell. The Company believes the self-sustaining signal caused
by its IL-15 cross-linker may enable prolonged and enhanced
proliferation and activation of NK cells similar to the increased
proliferation of T-cells caused by 41BB-L or CD28 intracellular
domains in CAR-T therapy but without the need to enhance the
patient's NK cells ex
GTB-1550 (OXS-1550): Most Advanced Bi-specific ADC
Company's most advanced bi-specific ADC in development,
targets CD19+ and/or CD22+ hematological malignancies and is
currently in the Phase 2 component of a Phase 1/2
Non-Hodgkin's Lymphoma (NHL)/Acute Lymphocytic Leukemia (ALL)
trial which is an open-label, investigator-led study.
targets cancer cells expressing the CD19 receptor or CD22 receptor
or both receptors. 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 payload. GTB-1550 has
demonstrated success in a Phase 1 human clinical trial in patients
with relapsed/refractory B-cell lymphoma or leukemia.
Company recently assembled a Bi-Specific ADC Advisory Board to
collaboratively assess and interpret the GTB-1550 pre-clinical and
clinical data, including an interim review of the Phase 1/2 study.
Eighteen patients have been enrolled to date, including 12 NHL and