NeOnc hires CBCC for Phase IIa brain cancer trial

Newly Nasdaq-listed US biotech NeOnc has hired contractor CBCC Global Research to run clinical trials of a candidate brain cancer therapy in India.

The deal will see the Gujarat CRO recruit patients with grade 3 and 4 brain tumors for a Phase IIa study of NeOnc’s lead candidate, NEO100. Financial terms were not disclosed.

NeOnc executive chairman Amir Heshmatpour said, “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 enrollment this year, with a readout expected six to eight months after that,” he added.

CBCC — which has access to a network of thirty research sites across India — said it would conduct the study in compliance with good clinical practice (GCP) and good laboratory practice (GLP) standards in partnership with Anova Enterprises, NeOnc’s US trials contractor.

Anglo-US CRO Anova has worked on NEO100 since 2023 when it was hired to run paediatric trials of the drug. Also, the contractor helped prepare applications for FDA fast track status and rare paediatric designations.

Applications

NEO100 is an intranasally delivered form of ultra-purified perillyl alcohol that targets the IDH1 mutation component in grade 3 and 4 glioblastomas.

The drug, which was licensed from researchers at the University of South Carolina, is also being investigated as a delivery vehicle.

According to a recent NeOnc SEC filing, “laboratory experiments showed that intranasal NEO100 mixed with levodopa was able to reverse PD [Parkinson’s disease] symptoms in mice. A Phase I clinical trial is planned to study the impact on human patients.”

NASDAQ listing

NeOnc announced the CBCC deal in late March to coincide with its initial listing on the US Nasdaq global market.

The news also followed just days after NeOnc appointed Alan Chiang to its board of directors, citing his expertise in minimally invasive spine surgery, brain tumor treatment, and biotechnology innovation as motivations.

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