BEVERLY HILLS, Calif.,
Aug. 23, 2021 /PRNewswire/ -- GT
Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology
company focused on developing innovative therapeutics based on the
Company's proprietary natural killer (NK) cell engager,
TriKE® protein biologic technology platform,
today announced the promotion of Gregory
Berk, M.D., to the position of President of Research &
Development and Chief Medical Officer. Dr. Berk has been
serving as Chief Medical Officer and prior to that was a Director
on the GT Biopharma Board. Dr. Berk will assume additional
responsibilities, including discovery, non-clinical development,
clinical development, and manufacturing.
"The Company is in the process of transferring GMP manufacturing
from the University of Minnesota to
Cytovance® Biologics, and Dr. Berk will be working
closely with our Consulting Chief Scientific Officer, Dr.
Jeffrey Miller and his team at the
University of Minnesota together with a
team of outstanding manufacturing and regulatory colleagues to
ensure this process is done with both the highest quality and as
quickly as possible. Dr. Berk's promotion speaks to the priority of
this for the company," said Anthony
Cataldo, Chief Executive Officer of GT Biopharma.
GT Biopharma is developing GTB-3550, a trispecific natural
killer (NK) cell engager TriKE®, for the
treatment of relapsed/refractory acute myelogenous leukemia (AML)
and high-risk myelodysplastic syndrome (MDS). The trial is in Phase
1 dose escalation and interim Phase 1 clinical data will be
presented next month in an oral session at the European Society of
Medical Oncology (ESMO) Annual Congress. The Company has also
previously announced it will be advancing additional solid
tumor-directed TriKE® product candidates into the
clinic in 2022.
Dr. Berk brings over 30 years of experience and expertise in
oncology drug development across medicine, industry and academia.
Prior to joining GT Biopharma, Dr. Berk was Chief Medical Officer
of Celularity, where he was responsible for the company's oncology,
infectious and degenerative disease programs. Previously, he served
as Chief Medical Officer of Verastem; President, Chief Medical
Officer, and Board Member of Sideris Pharmaceuticals; Chief Medical
Officer of BIND Therapeutics, and Chief Medical Officer of
Intellikine, which was acquired by Takeda/Millennium. Prior to his
roles as Chief Medical Officer, Dr. Berk was Senior Vice President
of Global Clinical Development at Abraxis BioScience, where he was
responsible for the Company's overall clinical strategy, including
efforts to expand the indications for its lead clinical program,
Abraxane®, as well as oversee the clinical development
of its clinical pipeline. Dr. Berk also served on the integration
leadership team during the Celgene, $3.7
Billion acquisition of Abraxis in 2010.
Dr. Berk obtained his medical degree from Case Western Reserve University and completed his
internship, residency, and fellowship in internal medicine,
hematology, and medical oncology at the Weill
Medical College of Cornell University and New York
Presbyterian Hospital, where he also served as a faculty member
from 1989-2004. During this time, Dr. Berk served as an
investigator on several industry-sponsored and cooperative group
oncology clinical trials, including the pivotal trials for
Gleevec® and Avastin®.
About GT Biopharma, Inc.
GT Biopharma, Inc. is a clinical stage biopharmaceutical company
focused on the development and commercialization of immuno-oncology
therapeutic products based on our proprietary
TriKE® NK cell engager platform. Our
TriKE® platform is designed to harness and
enhance the cancer killing abilities of a patient's immune system's
natural killer cells. GT Biopharma has an exclusive worldwide
license agreement with the University of
Minnesota to further develop and commercialize therapies
using TriKE® technology. For more information,
please visit gtbiopharma.com.
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 Annual Report on Form 10-K for the year
ended December 31, 2020, our
subsequent current reports on Form 8-K, our Quarterly Report on
Form 10-Q for the quarter ended March 31,
2021, and our other 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, 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.
TriKE® is a registered trademark owned by GT
Biopharma, Inc.
Contacts:
Investor
Relations:
David
Castaneda
David@gtbiopharma.com
414-351-9758
View original content to download
multimedia:https://www.prnewswire.com/news-releases/gt-biopharma-announces-the-promotion-of-dr-gregory-berk-to-president-of-research--development-and-chief-medical-officer-301360101.html
SOURCE GT Biopharma, Inc.