Qualigen Therapeutics Partners with TD2 for Phase 1 Clinical Development of QN-302 for the Treatment of Advanced or Metastatic Solid Tumors
August 17 2023 - 8:30AM
Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage
therapeutics company focused on developing treatments for adult and
pediatric cancers with potential for Orphan Drug Designation,
announced today it is partnering with Translational Drug
Development (TD2) as the contract research organization (CRO) to
conduct the Phase 1 clinical development of lead drug candidate
QN-302. Qualigen received US FDA IND clearance earlier this month
to initiate a Phase 1 clinical trial of QN-302, a small molecule
G-Quadruplex (G4)-selective transcription inhibitor, for the
treatment of advanced or metastatic solid tumors.
Tariq Arshad, M.D., M.B.A., Chief Medical
Officer, stated: “I am delighted that the FDA has cleared QN-302 to
enter the clinic for the proposed Phase 1 clinical trial in
patients with advanced or metastatic patients with solid tumors.
This furthers our ongoing investigation of a potentially exciting
new therapeutic approach for this group of cancer patients with
high unmet medical need along with our assessment of corresponding
biomarkers relevant to G4 expression. TD2, our CRO partner, has
been instrumental in bringing us to this point. Their demonstrated
ability to meet critical timelines within budget reinforces its
status as an industry leader in preclinical and clinical oncology
drug development, maximizing the opportunity for QN-302 to reach
the patients who need it the most.”
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.
“The successful IND filing of QN-302 is the
result of a strong partnership and shared dedication between
Qualigen and TD2 to advance cancer therapeutics into patients who
may have run out of options," said Stephen Gately, Ph.D., President
and CEO of TD2. "We appreciate the chance to work with Qualigen on
this exciting development program and look forward to the upcoming
clinical data.”
Qualigen Therapeutics secured exclusive
worldwide rights to QN-302 in January 2022 from University College
London (UCL). QN-302 was invented and developed by Professor
Stephen Neidle and his team from the UCL School of Pharmacy, one of
the top ten pharmacy and pharmacology research institutions in the
world. Professor Neidle has a distinguished 30+ year history in
nucleic acid research and drug design with over 500 published
papers and 14 patents and has been a member of Qualigen’s QN-302
Scientific Advisory Board since February 2022.
Professor Neidle stated, “I’m delighted that our
novel experimental drug QN-302 is at this very exciting stage of
now having FDA clearance for clinical evaluation. We are so pleased
that Qualigen has not only shared our vision but has taken QN-302
with remarkable skill and speed to this important milestone. I am
proud that we have long been a pioneer of the quadruplex targeting
concept and now look forward to the clinical development of
QN-302.”
Qualigen plans to initiate activation of the
first Phase 1 clinical trial site and enroll the first patient in
the Phase 1 dose escalation clinical study later this year.
Qualigen will enroll patients with advanced or metastatic solid
tumors who have failed prior therapy.
About QN-302
QN-302 is a small molecule G-Quadruplex
(G4)-selective transcription inhibitor in Phase 1 clinical
development for the treatment of G4-expressing solid tumors, such
as pancreatic cancer (PDAC), prostate cancer, sarcomas, and others.
QN-302 stabilizes G4 complexes prevalent in the promoter region of
oncogenes in many tumor types, impeding transcription of
G4-containing cancer genes and may potentially offer a
tumor-agnostic clinical approach to treatment. Orphan Drug
Designation (ODD) was granted by the FDA in January of this year
for QN-302 for the intended indication of pancreatic cancer.
About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a clinical-stage
therapeutics company focused on developing treatments for adult and
pediatric cancer. 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. The investigational compounds within Qualigen’s
family of Pan-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.
About Translational Drug Development (TD2)
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. Our 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 development of its therapeutic drug candidates,
including the anticipated timeline for initiating the Company’s
Phase 1 clinical trial and enrolling and dosing of patients and the
identification of a late in vivo candidate. Actual events or
results may differ from the Company's expectations. There can be no
assurance that the Company will be able to successfully develop any
drugs (including QN-302, Pan-RAS and QN-247); that preclinical
development of the Company's drugs (including Pan-RAS and QN-247)
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; or 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, Pan-RAS and QN-247). The
Company's stock price could be harmed if any of the events or
trends contemplated by the forward-looking statements fail 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 annual report on 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.
For more information about Qualigen
Therapeutics, Inc., please visit www.qlgntx.com.
Contact:Investor Relations760-530-6487ir@qlgntx.com.
Source: Qualigen Therapeutics, Inc.
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