BioEclipse Therapeutics will welcome CRO and CMO pitches from mid-2021 for its Phase II CRX100 trial in refractory solid tumours, said CEO Pamela Contag. BioEclipse is working with multiple CROs for its ongoing Phase I basket trial, including C3 Research, X-CellSystem, RMC Pharma and Ward Biotechnology Consulting, Contag added.
In the Phase II, the successful CRO will be responsible for trial site management, Contag said. California-based BioEclipse is not fixated on a specific location where the CRO should be based, she added. There is no more granular information available on the Phase II yet, including its design, she said.
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As for Phase II CMO decisions, the ideal CMO would expand CRX100’s manufacturing in Europe and Asia, Contag said, adding such ex-US manufacturing sites would be ideal if BioEclipse seeks to expand its operations globally. Currently, CRX100 is manufactured at the University of California San Diego Advanced Cell Therapy Laboratory, she added.
Meanwhile, BioEclipse is working with multiple CROs in the Phase I to help the trial move faster, Contag said. All CROs were chosen based on their experience and expertise in their chosen fields, she added. The ongoing Phase I is recruiting patients with triple-negative breast, epithelial ovarian, colorectal and gastric cancers, as well as patients with hepatocellular carcinoma and osteosarcoma. The Phase I has a primary completion date of May 2022, according to ClinicalTrials.gov.
Seattle-based C3 Research is providing clinical monitoring, medical monitoring, biostatistics and data management, as well as a data and safety monitoring board, said C3 director Ron Carozza. X-CellSystem, which is also based on Seattle, is providing consulting services, as well as apheresis qualifications and logistics support, noted X-CellSystem CEO Linda Barnes.
Phase I quality control is being undertaken by Longmont, Colorado-headquartered RMC Pharma, Contag noted. Ward Biotechnology, which is based in Washington State, is managing the CMC elements of the trial, she said. RMC Pharma and Ward Biotechnology did not respond to a request for comment.
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By GlobalDataAccording to a 28 April media release, BioEclipse also enlisted Spannerwerks to help BioEclipse secure IND clearance for the Phase I. Seattle-based Spannerwerks is providing project management, FDA engagement, GMP manufacturing and clinical trial management, CEO Dara Lockert told this news service.
The Phase I trial is a dose-escalation study with a safety primary endpoint, and is also looking into pharmacokinetic properties of CRX100. It aims to recruit up to 24 patients with advanced solid tumours unresponsive to standard of care.
Intravenously delivered CRX100 features tumour-locating cytokine-induced kills (CIK) cells and an oncolytic virus. CIK cells carry the oncolytic virus to the tumour, after which a burst of viral replication from within tumour cells lead to cell death.
Sean Rai-Roche is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.
