- U.S. FDA authorizes NeOnc to initiate Phase 1/2 clinical trials of NEO212.
- Clinical trials to evaluate NEO212 as a single agent for patients with primary brain tumors or uncontrolled brain metastasis.
- NEO212 to be tested in combination with common standard of care treatments in patients with colorectal, esophageal, gastric, kidney, lung, skin, head and neck, and other cancer types that spread to the brain.
- NEO212 will be the second product advanced by NeOnc into clinical trials.
LOS ANGELES, June 27, 2023 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc., a clinical stage biopharmaceutical company (the “Company,” “NeOnc”), has received authorization by the U.S. Food and Drug Administration (FDA) for the Phase 1/2 clinical study of NEO212, the Company’s drug conjugate therapeutic under development. NEO212 is designed to more efficiently deliver a DNA alkylating agent to the brain for treatment of primary brain tumors and for brain metastases that arise from other cancers.
The Phase 1 portion of the clinical trial is available to patients with primary brain tumors (cancers that start in the brain) and patients with brain metastasis originating from solid tumors which frequently arise from cancers of the colon, esophagus, kidney, lung, and skin. The main objective of the trial is to assess the safety and preliminary efficacy of NEO212.
In the Phase 2 portion of the study, the safety and efficacy of single agent NEO212 will be evaluated in patients with primary gliomas and metastatic brain cancer.
Brain tumors are among the most fatal cancers, and account for a high degree of suffering and death. Approximately 24,810 new cases will be diagnosed in the U.S. in 2023, with the vast majority of these patients dying within five years. High grade gliomas (WHO 212 astrocytoma IDH1-mutant and glioblastoma IDH-wildtype) are highly aggressive, with most patients surviving less than two years despite the best currently available treatment.
“We believe receiving this authorization from the FDA will enable us to advance NEO212 into the clinic where we believe it can have a positive effect on treatment outcomes,” stated NeOnc CEO, Thomas Chen, MD, Ph.D. “Based on pre-clinical testing, we believe NEO212 may be effectively delivered to the brain to treat primary brain tumors.”
The clinical trial includes a Phase 2b portion where the safety and efficacy of NEO212 will be evaluated in combination with current standard of care treatments. This adaptive design will assess the safety and efficacy of NEO212 in combination with common standard of care therapies for patients with cancers that develop uncontrolled brain metastasis.
Metastases to the brain are the most common brain tumors in adults and this develops in nearly 30% of patients with solid tumors. Traditional cytotoxic drugs have had a limited role in the management of these cancers and no standard systemic therapy exists.
Added Dr. Chen: “We believe that NEO212 could have a meaningful impact on solid tumor patients who develop uncontrolled brain metastasis and who are often excluded from traditional clinical trials. We also believe that NEO212 may have the potential to treat primary brain tumors as well as potentially work with systemic therapy to improve outcomes in patients who develop brain metastasis.”
The biotechnology strides generated by NeOnc’s patented NEO platform are the result of more than a decade of research at University of Southern California (USC) by Dr. Chen and his medical and scientific teams.
NeOnc executive vice-chairman, Amir Heshmatpour, commented: “We’re excited to have our NEO212 Investigative New Drug application approved by the FDA so we can start our clinical trials. We look forward to further advancing our NeOnc platform, which we believe could potentially impact the standard of care for primary brain tumors and other cancers that can spread to the brain.”
About NeOnc Technologies Holdings, Inc.
NeOnc is a privately held clinical-stage biopharmaceutical company focused on creating novel drugs and delivery methods for pharma-based therapeutics that target brain and central nervous system diseases. The Company’s NEO212 is its second therapeutic that has moved into human clinical trials. NeOnc is also developing several proprietary chemotherapy agents that have shown positive effects in laboratory tests on various types of cancers. The Company has exclusively licensed a large worldwide patent portfolio from USC consisting of both issued patents and pending patent applications related to NEO100, NEO212 and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions. To learn more about NeOnc, 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.
The NeOnc Technologies Holding, Inc. (the “Company”) cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of 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 obligation, 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
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NeOnc Technologies Holdings, Inc.
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CMA Media Relations
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