Qualigen Therapeutics Engages TD2 as Contract Research Organization for Preclinical Development of QN-302
March 30 2022 - 09:15AM
Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life
sciences company focused on developing treatments for adult and
pediatric cancers with potential for Orphan Drug Designation, while
also commercializing diagnostics, today announces it has appointed
the renowned contract research organization (CRO) Translational
Drug Development (TD2) to lead the preclinical development of lead
drug candidate QN-302. Qualigen is initially investigating QN-302
for the potential treatment of pancreatic ductal adenocarcinoma
(PDAC), which represents the vast majority of pancreatic cancers.
“This is an important step forward in our
development work to bring QN-302 through the IND process and into
the clinic,” stated Tariq Arshad, M.D., M.B.A., Qualigen’s Chief
Medical Officer. “TD2’s expertise is focused on early stage
preclinical and clinical oncology drug development. Its unique
approach, geared at identifying clinical and regulatory strategies
where there is the greatest opportunity for success in the clinic,
was among the key reasons for partnering with TD2.”
TD2 is a precision oncology drug development
organization integrating preclinical, clinical, and regulatory
expertise and providing expert drug development services, including
the design and execution of oncology clinical trials. TD2 has a
proven track record of obtaining IND clearances and managing
complex trial designs, including recruitment for Orphan diseases,
to accomplish first patient dosing as quickly as possible.
“We are eager to begin our collaboration with
Qualigen and to develop a research program for QN-302 that results
in a suitable dataset for regulatory clearance. Our shared goal is
to accelerate the compound into the clinic where it may address an
unmet medical need that, to date, has few options,” added Stephen
Gately, Ph.D., President and CEO of TD2.
QN-302 is Qualigen’s genomic quadruplex
(G4)-selective transcription inhibitor platform being developed as
a potential treatment for PDAC, in addition to other tumors of high
unmet clinical need. PDAC is one of the world's most lethal
cancers, and the fourth-leading cause of cancer-related death in
the United States. Each year, an estimated 460,000 people
globally—and 60,000 in the United States—are diagnosed with PDAC,
and it annually causes approximately 430,000 deaths worldwide and
48,000 in the United States. Qualigen believes that QN-302 may
ultimately be eligible to obtain Orphan Drug Designation, with
potential for key regulatory advantages.
About Qualigen
Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified
life sciences company focused on developing treatments for cancer,
as well as maintaining and expanding its core FDA-cleared FastPack®
System, which has been used successfully in diagnostics for over 20
years. Our investigational QN-302 compound is a small molecule
selective transcription inhibitor with strong binding affinity to
G4s prevalent in cancer cells; such binding could, by stabilizing
the G4s against “unwinding,” help inhibit cancer cell
proliferation. Our investigational QN-247 compound inhibits
nucleolin, a key multi-functional regulatory protein that is
overexpressed in cancer cells; QN-247 may thereby be able to
inhibit the cells’ proliferation. QN-247 has shown promise in
preclinical studies for the treatment of acute myeloid leukemia
(AML). The investigational compounds within Qualigen’s RAS-F family
of RAS oncogene protein-protein interaction inhibitor small
molecules are believed to inhibit or block the binding of mutated
RAS genes’ proteins to their effector proteins, thereby leaving the
proteins from the mutated RAS unable to cause further harm. In
theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of
pancreatic, colorectal, and lung cancers. In addition to its
oncology drug pipeline, Qualigen has an established diagnostics
business which manufactures and distributes proprietary and highly
accurate rapid blood testing systems to physician offices and small
hospitals for the management of prostate cancer and other diseases
and health conditions.
For more information about Qualigen Therapeutics, Inc., please
visit www.qualigeninc.com.
About Translational Drug Development (TD2),
Inc.
TD2 is a leader in precision oncology, providing
innovative services for improved drug development. Using a
dedicated, expert team with broad experience and understanding in
cancer medicine, TD2 is uniquely positioned to support accelerated
development of novel therapeutics. Rigorous and high-throughput
translational preclinical development services, combined with
regulatory affairs expertise, enables customized clinical trial
design and execution. The broad suite of capabilities encourages
the timely selection of patient populations who are most likely to
benefit from a new agent, and the rapid identification of
clinically significant endpoints. TD2 is committed to reducing the
risks and uncertainty inherent in the drug development process with
the ultimate goal of accelerating patient access to promising
treatments. For more information, visit www.TD2inc.com.
Forward-Looking Statements
This news release contains forward-looking
statements by Qualigen that involve risks and uncertainties and
reflect the Company's judgment as of the date of this release.
These statements include those related to the Company's prospects
and strategy for the development of therapeutic drug candidates.
Actual events or results may differ from the Company's
expectations. For example, there can be no assurance that the
Company will successfully develop any drugs (including QN-302,
QN-247 and RAS-F); that preclinical development of the Company's
drugs (including QN-302, QN-247 and RAS-F, and the deprioritized
infectious-disease drug candidate QN-165) will be completed on any
projected timeline or will be successful; that any clinical trials
will be approved to begin by or will proceed as contemplated by any
projected timeline, or at all; that any future clinical trial data
will be favorable or that such trials will confirm any improvements
over other products or lack negative impacts; that any drugs will
receive required regulatory approvals (or Fast Track designation or
Orphan Drug status) or that they will be commercially successful;
that patents will issue on the Company's owned and in-licensed
patent applications; that such patents, if any, and the Company's
currently owned and in-licensed patents would prevent competition;
that the Company will be able to procure or earn sufficient working
capital to complete the development, testing and launch of the
Company's prospective therapeutic products (including QN-302,
QN-247 and RAS-F, and QN-165); or that the Company will be able to
maintain or expand market demand and/or market share for the
Company's diagnostic products. The Company's stock price could be
harmed if any of the events or trends contemplated by the
forward-looking statements fails to occur or is delayed or if any
actual future event otherwise differs from expectations. Additional
information concerning these and other risk factors affecting the
Company's business can be found in the Company's prior filings with
the Securities and Exchange Commission, including its most recent
Form 10-K, all of which are available at www.sec.gov.
The Company disclaims any intent or obligation
to update these forward-looking statements beyond the date of this
news release, except as required by law. This caution is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Contact:
Jules AbrahamJQA Partners,
Inc.917-885-7378jabraham@jqapartners.com
Source: Qualigen Therapeutics, Inc.
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