NeOnc Technologies Holdings, Inc., a clinical-stage medical
biotechnology company, received FDA approval to expand its ongoing
NEO100-01™ Phase 2a clinical trial to include Recurrent Grade III
Astrocytoma with Isocitrate Dehydrogenase 1 (IDH1) mutation.
The FDA approval expands the current clinical trial, “An
Open-Label, Phase 1/2a Dose Escalation Study of Safety and Efficacy
of NEO100 in Recurrent Grade IV Glioma,” from only Recurrent Grade
IV tumors that more often affects senior adults (typically 50-80
years of age) to a younger patient population (typically ages
30-40) that are more often affected by Grade III.
NeOnc looks to build upon the published results from its Phase 1
clinical safety study which demonstrated greater survival rates
with NEO100-01, and particularly with patients who received
additional treatments cycles and those with the IDH1 marker, as
well as against current standard-of-care treatments.
“This significant approval advances the research and development
of our NEO™ technology platform and its ability to produce novel
drugs and delivery methods designed to address the persistent
challenges with overcoming the blood-brain barrier,” stated NeOnc
CEO and founder, Thomas Chen, MD, Ph.D. “Moreover, it opens the
field for us to investigate how NEO100-01 could be safe and
efficacious for younger populations before their cancers
potentially worsen to Grade IV.”
An estimated 1 million Americans are living with a primary brain
tumor, with an estimated 26,940 new malignant tumor cases diagnosed
in the U.S. last year, according to the National Brain Tumor
Society. For patients with malignant brain tumors, the five-year
relative survival rate following diagnosis remains at less than
36%.
Recurrent Grade III Astrocytoma with IDH1 mutations are also
known to manifest as aggressively as its Grade IV/IDH1
counterparts, which further highlights the importance of the study
expansion.
The biotechnology strides generated by NeOnc's patented NEO
platform are the result of more than a decade of research at the
University of Southern California (USC) by Dr. Chen and his medical
and scientific teams. Dr. Chen has been leading the company’s
Phase I and II clinical trials.
According to NeOnc executive chairman, Amir Heshmatpour: “This
expansion of NEO100's applicability truly marks a monumental step
forward for NeOnc Technologies. By broadening the inclusion
criteria to encompass patients with Recurrent Grade III Astrocytoma
with the IDH1 mutation, we not only advance our innovative platform
but also provide new hope for patients who previously had limited
treatment options.”
“Our drive to push the boundaries of brain cancer treatment has
never been stronger,” added Heshmatpour, “and this trial expansion
is a testament to our team’s dedication to transforming patient
outcomes.”
By enabling better drug delivery to the brain cancer, the
company believes its NEO technology can turn existing FDA-approved
drugs into more effective treatments across a full range of central
nervous system (CNS) disorders. The company is developing several
additional proprietary chemotherapy agents that have demonstrated
positive effects in laboratory tests on other various types of
cancers.
“As we continue to consult with the FDA under its Orphan Drug
and Fast-Track status, we expect to collect sufficient data that
demonstrates the important therapeutic value of our four leading
drug candidates,” added Dr. Chen. “We believe our novel intranasal
delivery approach will enable studies in difficult groups,
including the pediatric population.”
“Radiation and chemotherapy, especially for children and senior
adults with high-grade gliomas, is complex, time consuming and
prognosis remains poor,” added Dr. Chen. “This underscores the
importance of us developing effective therapies that are less
invasive and more tolerable for challenged populations.”
About Astrocytoma Category Types
The World Health Organization categorizes Astrocytoma into four
grades. The grades depend on how fast the Astrocytoma grows and the
likelihood that it will spread to or infiltrate nearby brain
tissue.
Grade I Astrocytoma is the mildest form of brain cancer which
most often affects children and teens.
Grade II Astrocytoma most often affect adults between the ages
20 and 60. These types of cancers tend to spread to nearby brain
tissue, so surgery alone might not be enough to treat them.
Grade III Astrocytoma most often affect adults between 30 and 60
years of age. Grade III often presents as a progression from Grade
II and is more aggressive. Surgery alone never cures these tumors;
they require radiation and almost always require chemotherapy.
Grade IV Astrocytoma, also known as Glioblastomas, are the most
common type of brain cancer in adults and account for 24% of all
brain tumors. They are also the most dangerous and aggressive type
of Astrocytoma and are known to spread quickly. They can either
present as a cancerous progression from a previously existing
lower-grade Astrocytoma (10% of cases) or begin as a Grade IV tumor
(90% of cases).
About NeOnc Technologies Holdings
NeOnc Technologies is a privately held clinical stage life
sciences company focused on the development and commercialization
of central nervous system therapeutics that are designed to address
the persistent challenges in overcoming the blood-brain
barrier.
The company’s NEO™ drug development platform has produced a
portfolio of novel drug candidates and delivery methods with patent
protections extending to 2038. These proprietary chemotherapy
agents have demonstrated positive effects in laboratory tests on
various types of cancers and in clinical trials treating malignant
gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase I
and II human clinical trials, and are advancing under FDA
Fast-Track and Investigational New Drug (IND) status.
The company has exclusively licensed an extensive worldwide
patent portfolio from the University of Southern California
consisting of issued patents and pending applications related to
NEO100, NEO212, and other products from the NeOnc patent family for
multiple uses, including oncological and neurological
conditions.
For more about NeOnc and its pioneering technology, visit
neonctech.com.
Important Cautions Regarding Forward-Looking
Statements
All statements other than statements of historical facts
included in this press release are "forward-looking statements" (as
defined in the Private Securities Litigation Reform Act of 1995).
Generally, such forward-looking statements include statements
regarding our expectations, possible or assumed future actions,
business strategies, events, or results of operations, including
statements regarding our expectations or predictions or future
financial or business performance or conditions and those
statements that use forward-looking words such as "projected,"
"expect," "possibility" and "anticipate," or similar expressions.
The achievement or success of the matters covered by such
forward-looking statements involve significant risks,
uncertainties, and assumptions. Actual results could differ
materially from current projections or implied results.
NeOnc Technologies Holding, Inc. (the "Company") cautions that
statements and assumptions made in this news release constitute
forward-looking statements without guaranteeing future performance.
Forward-looking statements are based on estimates and opinions of
management at the time statements are made. The information set
forth herein speaks only as of the date hereof. The Company and its
management are under no obligation, and expressly disclaim any
responsibility, to update, alter, or otherwise revise any
forward-looking statements following the date of this news release,
whether because of new information, future events, or otherwise,
except as required by law.
NeOnc Company Contact: Patrick
Walters COO NeOnc Technologies Holdings, Inc. Email
Contact
NeOnc Investor Relations: Ron Both or
Grant StudeCMA Investor Relations Tel (949)
432-7566 Email Contact
NeOnc Media & ESG Contact: Tim
Randall CMA Media Relations Tel (949) 432-7572 Email
Contact
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