NeOnc Technologies Holdings, Inc. (Nasdaq Global Market: NTHI), a clinical-stage medical biotechnology company, today announced a strategic partnership with CBCC Global Research (CBCC), a premier full-service clinical research organization (CRO). This collaboration will expand NeOnc’s clinical trial capabilities in India, facilitating the advancement of its development-stage neuro-oncology treatment.
Through this partnership, NeOnc will initiate clinical trials across 30 FDA-compliant clinical research sites in India, increasing patient enrolment and accelerating development efforts for a novel therapy designed to target aggressive brain tumors.
CBCC will initially recruit for the NEO100-01 Glioblastoma (GBM) clinical trial, which is a Phase 2a study evaluating the survival impact and tolerance of intranasal NEO100, an ultra-purified perillyl alcohol with a focus on the IDH1 mutation component in Grade 3 and 4 GBM tumours.
“Our collaboration with CBCC represents an important milestone and step forward in our clinical development strategy,” said Amir Heshmatpour, Executive Chairman of NeOnc Technologies. “Conducting our trials in India allows us to accelerate patient recruitment, maintain regulatory compliance, and expedite the potential approval of these promising therapies for patients in need. We are focused on completing our Phase 2 NEO100-01 enrolment this year, with a readout expected 6 to 8 months after that.”
The FDA-aligned trials in India will be conducted under Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards, ensuring high-quality data generation and regulatory adherence. CBCC will oversee trial execution in coordination with NeOnc’s U.S.-based CRO, Anova Enterprises, ensuring streamlined operations.
“We are dedicated to advancing breakthrough therapies for brain cancer, and launching trials in India represents a critical step in that mission,” said Thomas Chen, MD, Ph.D., CEO of NeOnc Technologies. “By broadening our clinical reach, we are accelerating the path to market for our transformative treatments, while ensuring we reach a more diverse patient population.”
“India is emerging as a key hub for clinical research, and we are honoured to support NeOnc in their mission to advance innovative neuro-oncology treatments,” said Manoj Vyas, CEO of CBCC Global Research. “With our deep expertise in clinical trial management and regulatory pathways, we are confident that this partnership will drive critical advancements in cancer therapeutics.”
This expansion underscores NeOnc Technologies’ commitment to accelerating the development of transformative therapies and improving patient outcomes worldwide. The company anticipates rapid enrolment and progress in these studies, bringing it closer to potentially delivering next-generation treatments for brain cancer and other challenging diseases.