temozolomide/perillyl alcohol conjugate (NEU001) / NeOnc Technologies, NeuCen BioMed - LARVOL DELTA

A randomized, double-blind, placebo-controlled, single dose phase Ia study to investigate the safety, tolerability, pharmacokinetics of Neu-001 following subcutaneous injection in healthy adult participants (ChiCTR) - P1 | N=53 | Not yet recruiting | Sponsor: Shanghai First People's Hospital; Shanghai First People's Hospital

New P1 trial • CNS Disorders • Ophthalmology

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 (GlobeNewswire) - "Independent review of the recommended Phase II dose is ongoing, with patient enrollment expected to begin before the end of 2025."

FDA event • Trial status • Brain Cancer

Potent Therapeutic Activity of NEO212 in Preclinical Models of Human and Canine Leukaemia and Lymphoma. (PubMed, Vet Comp Oncol) - "We are developing a novel anticancer agent, NEO212, a conjugate of two cancer drugs, the alkylating agent temozolomide (TMZ) and the monoterpene perillyl alcohol (POH). At the same time, NEO212 is well tolerated in dogs at dosages higher than those that achieved therapeutic activity in mouse models. Our study introduces NEO212 as a novel oral cancer drug candidate for both human and veterinary oncology applications."

Journal • Preclinical • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Oral Cancer • Solid Tumor

NeOnc Technologies Announces Near Completion of Phase I Enrollment for NEO212 Brain Cancer Therapy (GlobeNewswire) - "NeOnc Technologies Holdings...announced that its Phase I clinical trial of NEO212, a development-stage bio-conjugated therapeutic for brain cancer, is nearing full enrollment. The final cohort (Cohort 5) is expected to complete the study’s dosing protocol, marking a major milestone in the drug’s development timeline....The NEO212 trial protocol includes five escalating cohorts (3 patients per cohort)."

Trial status • Astrocytoma • Glioblastoma

NeOnc Initiates Cohort 3 in Phase 1 Clinical Trial of NEO212, a Patented Novel Hybrid Drug Designed to Deliver ‘Double Punch’ Against Malignant Brain Tumors (GlobeNewswire) - "NeOnc Technologies Holdings, Inc...has begun enrollment of patients for Cohort 3 out of 6 of the Phase 1 clinical trial of NEO212....The advancement to Cohort 3 follows successful completion of the first two cohorts. The company anticipates the final cohort to be completed by the end of December."

Trial status • Glioblastoma

NEO212, temozolomide conjugated to NEO100, exerts superior therapeutic activity over temozolomide in preclinical chemoradiation models of glioblastoma. (PubMed, Neurooncol Adv) - "NEO212 is a candidate drug to potentially replace TMZ within the standard Stupp protocol. It has the potential to become the first chemotherapeutic agent to significantly extend overall survival in TMZ-resistant patients when combined with radiation."

Journal • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Hematological Malignancies • Oncology • Solid Tumor

Activation of Epstein-Barr Virus' Lytic Cycle in Nasopharyngeal Carcinoma Cells by NEO212, a Conjugate of Perillyl Alcohol and Temozolomide. (PubMed, Cancers (Basel)) - "The Epstein-Barr virus (EBV) is accepted as a primary risk factor for certain nasopharyngeal carcinoma (NPC) subtypes, where the virus persists in a latent stage which is thought to contribute to tumorigenesis. Inclusion of the antiviral agent ganciclovir synergistically enhanced the cytotoxic impact of NEO212, pointing to a potential combination treatment for EBV-positive cancers which should be explored further. Overall, our study establishes NEO212 as a novel agent able to stimulate EBV's lytic cycle in NPC tumors, with implications for other virus-associated cancers."

Journal • Epstein-Barr Virus Infections • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: Neonc Technologies, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • IO biomarker • Astrocytoma • Brain Cancer • CNS Tumor • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • PD-L1

Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis (clinicaltrials.gov) - P1/2 | N=134 | Not yet recruiting | Sponsor: Neonc Technologies, Inc.

IO biomarker • New P1/2 trial • Astrocytoma • Brain Cancer • Cervical Cancer • CNS Tumor • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Microsatellite Instability • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

NeOnc Technologies Holdings Receives FDA Authorization to Proceed with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy (GlobeNewswire) - "NeOnc Technologies Holdings, Inc...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."

IND • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

An Expert’s Guide to ASCO 2022: Preview of the Top Abstracts (Clinical Care Options) - "In gynecologic cancers, Angeles Alvarez Secord, MD, MHSc, selected the following highly anticipated studies at the meeting. ATHENA-MONO (GOG-3020/ENGET-ov45)...MITO23...innovaTV 205/ENGOT Cx8/GOG 3024...Hussein Tawbi, MD, PhD, and Allison Betof Warner, MD, PhD, have identified several key studies in skin cancer of interest at ASCO 2022."

ABVC BioPharma Enters Into $3.0 Million Clinical Services Contract with NeuCen BioMed (GlobeNewswire) - "ABVC Biopharma, Inc...today announced that BioKey...has entered into a $3.0 million clinical services contract with NeuCen BioMed Co. Ltd. to guide two NeuCen drug products, CEN501 and NEU001, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements...NEU001 is a novel drug entity that has received orphan-drug designation from the U.S. FDA for the treatment of nasopharyngeal carcinoma."

Licensing / partnership • Nasopharyngeal Carcinoma • Oncology