Qualigen Therapeutics Announces IND-Enabling Studies to Advance Lead Program QN-302 Toward Clinical Trials
June 07 2022 - 9:04AM
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 initiated
Investigational New Drug, or IND-enabling, studies for its lead
therapeutic program, QN-302. These initial safety and pharmacology
studies represent an important milestone for QN-302, which is being
developed to treat pancreatic cancer, and potentially prostate
cancer and other solid tumors.
The Company also announces that it has
established an in vivo maximum tolerated dose of QN-302, which
corroborates a therapeutic window for target indications as
demonstrated in earlier efficacy studies. Qualigen’s recently
initiated IND-enabling studies, combined with the data package
in-licensed from University College London (UCL), align with the
timeline for the submission of an IND application to the U.S. Food
and Drug Administration (FDA) during the first half of 2023.
Tariq Arshad, M.D., Qualigen's Chief Medical
Officer, commented, “To date, we are on target to hit our key
milestones regarding the pre-clinical development of our exciting
lead program QN-302. We are encouraged by the progress we have made
through these initial IND-enabling studies, and we are confident
that we will continue to advance this program towards clinical
trials within budget and on schedule.”
The Company expects to initiate exploratory
toxicology during the third quarter, followed by initiation of GLP
(good laboratory practice) toxicology studies, and a pre-IND
interaction with the FDA targeted for the fourth quarter of 2022 to
generate input for the initial clinical study plan.
QN-302 is Qualigen’s G-quadruplex (G4)-selective
transcription inhibitor platform being developed as a potential
treatment for PDAC, in addition to other tumors of high unmet
clinical need. Pancreatic ductal adenocarcinoma (PDAC), which
represents the vast majority of pancreatic cancers, is one of the
world's most lethal cancers, and the fourth-leading cause of
cancer-related death in the United States. In 2019, there were an
estimated 89,248 people living with pancreatic cancer in the United
States.1 Drugs that treat rare cancers such as PDAC qualify for
Orphan Drug Designation (ODD) as the prevalence is < 200,000
cases.2 ODD therapeutic programs typically require smaller clinical
trials and have an expedited regulatory path.
About Qualigen
Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a diversified
life sciences company focused on developing treatments for adult
and pediatric 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.
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, including statements related to the development of
QN-302 and the Company’s other therapeutic drug candidates. Actual
events or results may differ from the Company's expectations. For
example, here can be no assurance that the Company will be able to
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;
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,
QN-247 and RAS-F, and QN-165). 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.
- https://seer.cancer.gov/statfacts/html/pancreas.html
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https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts
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