NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) announced a strategic partnership with CBCC Global Research to expand its clinical trial capabilities into India, significantly accelerating the development of novel brain cancer treatments. The collaboration will establish 30 FDA-compliant clinical research sites across India, enhancing patient recruitment for NeOnc's innovative neuro-oncology therapies.
The partnership will initially focus on the NEO100-01 Glioblastoma (GBM) clinical trial, a Phase 2a study evaluating the survival impact and tolerance of intranasal NEO100. This ultra-purified perillyl alcohol therapy specifically targets the IDH1 mutation component in Grade 3 and 4 GBM tumors, one of the most aggressive forms of brain cancer.
"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."
Expanding Global Research Footprint
The FDA-aligned trials in India will adhere to Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards, ensuring high-quality data generation and regulatory compliance. CBCC will coordinate trial execution with NeOnc's U.S.-based CRO, Anova Enterprises, creating a seamless operational framework across both countries.
Glioblastoma represents a significant unmet medical need, with approximately 13,000 new cases diagnosed annually in the United States alone. The current standard of care offers limited efficacy, with median survival typically ranging from 12-15 months after diagnosis, highlighting the urgent need for innovative therapeutic approaches.
Thomas Chen, MD, Ph.D., CEO of NeOnc Technologies, emphasized the strategic importance of this expansion: "We are dedicated to advancing breakthrough therapies for brain cancer, and launching trials in India represents a critical step in that mission. 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."
Accelerating Development Timeline
NeOnc Technologies expects this partnership to significantly compress development timelines, with Phase 2 NEO100-01 enrollment projected to complete this year. Data readout is anticipated 6 to 8 months after enrollment completion, potentially fast-tracking the advancement of this promising therapy.
The company's NEO100 therapy represents a novel approach to treating brain tumors, utilizing an intranasal delivery method designed to overcome the blood-brain barrier—a significant challenge in developing effective treatments for central nervous system disorders.
"India is emerging as a key hub for clinical research, and we are honored 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."
Comprehensive Clinical Pipeline
Beyond the NEO100-01 trial, NeOnc Technologies maintains a robust pipeline of central nervous system therapeutics. The company's NEO™ drug development platform has produced multiple novel drug candidates with patent protections extending to 2038. Currently, NEO100™-01 and NEO100™-02 therapeutics are in Phase II trials, while NEO100™-03 and NEO212™ therapeutics are advancing through Phase I clinical trials under FDA Fast-Track and Investigational New Drug (IND) status.
This expansion into India represents a strategic move to leverage the country's growing prominence in clinical research. India offers access to a large, treatment-naïve patient population, experienced clinical investigators, and high-quality research infrastructure at competitive costs—all factors that can significantly accelerate drug development timelines.
The collaboration with CBCC Global Research, which has executed over 100 clinical trials across 500+ sites and supported more than 70 pharmaceutical and biotech companies in their clinical development efforts, positions NeOnc to efficiently navigate regulatory pathways in both U.S. and international markets.
As brain cancer continues to present formidable treatment challenges, this partnership underscores NeOnc Technologies' commitment to developing transformative therapies and improving patient outcomes worldwide. The company anticipates that the expanded clinical trial network will facilitate more rapid progress toward potentially delivering next-generation treatments for brain cancer and other challenging neurological diseases.
