NeOnc Technologies Receives FDA Authorization to Proceed with Phase II Clinical Trial of NEO212 – A First-in-Class Oral Chemical Conjugated Chemotherapy Candidate for Brain Cancer
NeOnc Technologies (NASDAQ: NTHI) has received FDA authorization to proceed with Phase IIa/IIb clinical trial of NEO212, its first-in-class oral chemical conjugated chemotherapy for brain cancer. The approval follows successful Phase I completion, which demonstrated safe administration at doses up to 810 mg daily on Days 1-5 of a 28-day cycle.
NEO212 combines Temozolomide (TMZ), the current standard treatment for glioblastoma, with NEO100, NeOnc's proprietary form of perillyl alcohol. The drug aims to overcome TMZ's limitations by enhancing blood-brain barrier penetration and antitumor activity. Patient enrollment is expected to begin by end of 2025, expanding from 4 current trial sites to multiple premier cancer institutions across the U.S.
NeOnc Technologies (NASDAQ: NTHI) ha ottenuto l'autorizzazione della FDA a procedere con uno studio clinico di Fase IIa/IIb su NEO212, la sua prima chemioterapia orale coniugata per il cancro al cervello. L'approvazione segue il completamento positivo della Fase I, che ha dimostrato la somministrazione sicura fino a 810 mg al giorno nei giorni 1-5 di un ciclo di 28 giorni.
NEO212 unisce Temozolomide (TMZ), lo standard terapeutico attuale per il glioblastoma, a NEO100, la forma proprietaria di perillaldeide di NeOnc. Il farmaco punta a superare i limiti della TMZ migliorando la penetrazione della barriera emato-encefalica e l'attività antitumorale. L'arruolamento dei pazienti è previsto entro la fine del 2025, con l'espansione da 4 centri attuali verso diverse istituzioni oncologiche d'eccellenza negli Stati Uniti.
NeOnc Technologies (NASDAQ: NTHI) ha recibido la autorización de la FDA para avanzar a un ensayo clínico de Fase IIa/IIb de NEO212, su primera quimioterapia oral conjugada para el cáncer cerebral. La aprobación sigue a la finalización exitosa de la Fase I, que demostró una administración segura hasta 810 mg diarios en los días 1-5 de un ciclo de 28 días.
NEO212 combina Temozolomida (TMZ), el tratamiento estándar actual para el glioblastoma, con NEO100, la formulación propietaria de perilil alcohol de NeOnc. El fármaco busca superar las limitaciones de la TMZ mejorando la penetración de la barrera hematoencefálica y la actividad antitumoral. Se espera que el reclutamiento de pacientes comience antes de finales de 2025, ampliándose desde los 4 sitios actuales a varias instituciones oncológicas de primer nivel en EE. UU.
NeOnc Technologies (NASDAQ: NTHI)가 뇌암 치료를 위한 최초의 경구 화학결합 항암제 NEO212의 임상시험 단계 IIa/IIb 진행에 대해 FDA 승인을 받았습니다. 이번 승인 전에는 성공적으로 완료된 1상에서 28일 주기의 1~5일에 하루 최대 810 mg까지 안전하게 투여할 수 있음이 입증되었습니다.
NEO212는 교모세포종의 현 표준 치료제인 테모졸로마이드(TMP)와 NeOnc의 독자적 페릴릴알코올 제형인 NEO100을 결합한 약물입니다. 이 약은 혈액뇌장벽 투과성과 항종양 효과를 향상시켜 TMZ의 한계를 극복하는 것을 목표로 합니다. 환자 등록은 2025년 말까지 시작될 예정이며, 현재 4개 시험 기관에서 미국 내 다수의 주요 암 전문 기관으로 확장될 계획입니다.
NeOnc Technologies (NASDAQ: NTHI) a obtenu l'autorisation de la FDA de lancer un essai clinique de Phase IIa/IIb de NEO212, sa première chimiothérapie orale conjuguée pour le cancer du cerveau. Cette approbation fait suite à la réussite de la Phase I, qui a montré une administration sûre jusqu'à 810 mg par jour les jours 1 à 5 d'un cycle de 28 jours.
NEO212 associe Temozolomide (TMZ), le traitement standard actuel du glioblastome, à NEO100, la forme propriétaire de perillyl alcohol de NeOnc. Le médicament vise à surmonter les limites de la TMZ en améliorant la pénétration de la barrière hémato-encéphalique et l'activité antitumorale. Le recrutement des patients devrait débuter d'ici la fin 2025, en passant des 4 sites actuels à plusieurs établissements oncologiques de premier plan aux États-Unis.
NeOnc Technologies (NASDAQ: NTHI) hat von der FDA die Genehmigung erhalten, eine Phase-IIa/IIb-Studie mit NEO212, seinem ersten oral verabreichten chemisch konjugierten Chemotherapeutikum gegen Hirntumore, durchzuführen. Die Zulassung folgt auf den erfolgreichen Abschluss der Phase I, in der eine sichere Verabreichung von bis zu 810 mg täglich an den Tagen 1–5 eines 28-Tage-Zyklus nachgewiesen wurde.
NEO212 kombiniert Temozolomid (TMZ), die derzeitige Standardbehandlung beim Glioblastom, mit NEO100, NeOncs proprietärer Form von Perillylalkohol. Das Medikament zielt darauf ab, die Einschränkungen von TMZ zu überwinden, indem es die Blut-Hirn-Schranke besser durchdringt und die antitumorale Wirksamkeit erhöht. Die Patientenrekrutierung soll bis Ende 2025 beginnen und die Studienorte von aktuell 4 auf mehrere führende Krebszentren in den USA ausgeweitet werden.
- Successful completion of Phase I trial demonstrating safety profile
- FDA authorization to proceed with Phase II clinical trial
- Potential to replace current standard of care (Temozolomide) for brain cancers
- Expansion from 4 to multiple premier cancer institutions for Phase II trials
- Novel drug design combining existing treatment with proprietary technology
- Patient enrollment not yet begun
- Phase II results still pending and uncertain
- Significant competition from existing standard of care (Temozolomide)
Insights
NeOnc's FDA authorization to advance NEO212 to Phase II represents significant clinical progress for their brain cancer therapy targeting limitations of current standard treatments.
The FDA's authorization for NeOnc Technologies to proceed with Phase II trials of NEO212 marks a critical development milestone in the brain cancer treatment landscape. The successful completion of Phase I with doses up to
NEO212's approach is scientifically noteworthy - it chemically conjugates Temozolomide (the current standard of care for glioblastoma) with their proprietary perillyl alcohol compound (NEO100). This conjugation aims to address two fundamental limitations of current therapy: blood-brain barrier penetration and tumor resistance mechanisms. These are precisely the challenges that have hindered meaningful advancement in glioblastoma outcomes for decades.
The expansion from four current trial sites to a planned network including major academic centers like Duke, Cleveland Clinic, and UCSF indicates confidence in the compound and preparation for robust patient enrollment. This multi-center approach will provide diverse patient data critical for regulatory consideration.
From a development perspective, targeting replacement of Temozolomide positions NEO212 in a well-defined commercial pathway. Rather than competing as an adjunctive therapy, NeOnc is directly challenging the standard of care, which represents a higher-risk but potentially higher-reward strategy in the difficult CNS oncology space where innovation has been frustratingly slow.
The Phase IIa/IIb design suggests a thorough evaluation approach, likely including both efficacy signals and dose optimization. Patient enrollment timeline (before end of 2025) aligns with typical development schedules following successful Phase I completion. While still years from potential approval, this authorization represents meaningful progress in the development of new treatment options for brain cancer patients with significant unmet needs.
CALABASAS, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial.
The FDA’s decision follows the successful completion of the Phase I dose-escalation study, which demonstrated that NEO212 could be safely administered at doses up to 810 mg daily on Days 1–5 of a 28-day cycle. Independent review of the recommended Phase II dose is ongoing, with patient enrollment expected to begin before the end of 2025.
A Next-Generation Standard of Care Candidate
NEO212 is NeOnc’s first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ) – the current standard of care for glioblastoma and other brain cancers (marketed as Temodar®) – with NEO100 (a proprietary form of perillyl alcohol (POH), which is owned and patented by NeOnc). This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity.
NeOnc believes NEO212 has the potential to replace TMZ as the future standard of care for all brain cancers, representing a transformative leap forward in therapeutic options for patients facing glioblastoma, astrocytoma, and other aggressive CNS malignancies.
Phase II Clinical Development Strategy
The NEO212-01 Phase II trial will expand patient enrollment across leading U.S. cancer centers, building on four currently approved and active trial sites:
- NextGen Oncology – Kumar Sankhala, MD
- Northwest Medical Specialties (NWMS) – Jorge Chaves, MD
- Oncology Physician’s Network – Vu Phan, MD
- University of Southern California (USC) – Frances Chow, MD
In anticipation of expanded Phase II enrollment, NeOnc is preparing activation at a broad network of premier cancer institutions, including:
Baylor Scott & White • Beverly Hills Cancer Center • Cancer Specialists of North Florida • Cleveland Clinic • Duke University • Inova (Virginia) • New York University Langone • Providence St. John’s • RecioMed (Florida) • Sutter Health • Tampa General Hospital • Vanderbilt University Medical Center • University of Texas Southwestern • University of California, San Francisco
Leadership Commentary
“Receiving FDA authorization to advance NEO212 into Phase II is a defining milestone for NeOnc Technologies,” said Amir Heshmatpour, Executive Chairman and President of NeOnc Technologies Holdings, Inc. “This program represents years of innovation combining our proprietary molecule NEO100 with the current standard Temozolomide into a powerful conjugated therapy that we believe can redefine treatment outcomes for brain cancer patients. Our Phase II strategy will expand across the country’s leading cancer centers and position NEO212 as the first real replacement for Temozolomide in decades.”
Dr. Thomas Chen, Chief Executive Officer and Founder of NeOnc Technologies, added:
“From the beginning, our mission has been to give brain cancer patients and their families real hope where few options exist. NEO212 embodies that vision – it is science and compassion fused together. Moving into Phase II is not just a regulatory step forward; it is a step toward changing the future of brain cancer care worldwide.”
About NeOnc Technologies Holdings, Inc.
NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) is a multi-Phase II clinical-stage biopharmaceutical company pioneering novel therapies for central nervous system cancers and other hard-to-treat malignancies. The Company’s portfolio includes NEO100 and NEO212, with proprietary intellectual property and clinical programs designed to deliver transformative outcomes for patients worldwide.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of NEO212 to become the new standard of care for brain cancer, anticipated patient enrollment timelines, and future clinical trial sites. These statements involve risks and uncertainties that could cause actual results to differ materially, including but not limited to clinical development risks, regulatory review processes, patient enrollment variability, and financial resource availability. NeOnc undertakes no obligation to update any forward-looking statements contained herein.
Company Contact:
info@neonc.com
Investor Contact:
James Carbonara
Hayden IR
(646)-755-7412
James@haydenir.com
FAQ
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