Qualigen Therapeutics Announces Partnership with Hande Sciences To Scale-Up Manufacturing To Support IND-Enabling Studies for QN-302
July 06 2022 - 9:00AM
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 its partnership
with China-based Hande Sciences (“Hande”) to conduct manufacturing
scale-up activities to support the Company’s IND-enabling good
laboratory practice (GLP) studies for its lead therapeutic program,
QN-302.
The Company has chosen Hande for its
capabilities in performing custom synthesis and process research
and development. Hande specializes in scale-up of small molecules
therapeutics and is building a large good manufacturing processes
(GMP) manufacturing site, which is expected to be completed in
August 2022. The agreement with Hande provides for process
development and scale-up batches of material for the Company’s GLP
toxicology studies, which the Company expects to commence in Q3 of
2022, as previously announced.
Tariq Arshad, MD, MBA, Qualigen's Chief Medical
Officer, commented, “We are on track to complete our IND-enabling
studies for QN-302 in the third and fourth quarters of 2022 and are
excited to partner with Hande, who has an excellent track record of
performance. We look forward to continuing to execute on our key
milestones with highly experienced collaborators in an efficient
and cost-effective manner.”
QN-302 is Qualigen’s G-quadruplex (G4)-selective
transcription inhibitor platform being developed as a potential
treatment for Pancreatic ductal adenocarcinoma (PDAC), in addition
to other tumors of high unmet clinical need, such as Prostate
Cancer. PDAC 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.
Founded in 2007, Hande Sciences is a leading
pharmaceutical contract development and manufacturing organization
(CDMO) in China, providing high-quality research and development
(R&D) and production services for global biotech and
pharmaceutical companies. It specializes in process development,
scale-up and manufacturing of advanced intermediates and active
pharmaceutical ingredients (APIs) under non-GMP and GMP and
accelerates the launch of new drugs, providing one-stop chemistry,
manufacturing, and controls (CMC) services for the full lifecycle
of drug development. Hande has an internationally recognized,
professional, and cohesive team supporting R&D and production.
It has campuses in Suzhou and Changshu where they have recently
built a state-of-the-art non-GMP and GMP pilot plant for kilo scale
and commercial launch scales up to metric tons with Environmental
Health and Safety (EHS) and Quality Assurance (QA) systems that
meet the requirements of Asia Pacific, European and US FDA and NMPA
requirements.
For more information about Hande Sciences, please visit
www.handesciences.com.
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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