Cellivery Completes Production of Clinical Dose of COVID-19 Immune Therapeutic iCP-NI

[Asia Economy Reporter Hyunseok Yoo] Cellivery announced on the 22nd that it has completed the production of the first batch for 400 patients and the second batch for 800 patients of the ‘intrinsic immune-regulating COVID-19 immunotherapy iCP-NI,’ which is about to enter clinical trials in the United States.

Cellivery produced 1000g of iCP-NI required for non-clinical trials, which was used for evaluating therapeutic efficacy and safety. The production of the active pharmaceutical ingredient for 1200 patients to be used in the U.S. clinical trials has also been completed, and it is currently being filled as a finished pharmaceutical product at Integrity Bio located in California, USA. Cellivery explained that, as the number of COVID-19 patients is increasing worldwide, it adjusted the production volume anticipating a further rise in clinical patient demand.

Additionally, pharmacokinetic and toxicokinetic analyses were completed at Covance in the U.S. on all plasma samples from non-human primates that underwent GLP-level toxicity testing. These results were delivered to the dedicated clinical trial planning and regulatory department for iCP-NI at another Covance, the clinical trial contract research organization. The company stated that the clinical synopsis design has already begun.

Cellivery CEO Daewoong Cho said, "All conditions necessary for clinical entry are being met," and added, "We will finalize this well with Covance and proceed smoothly with pre-discussions with the FDA and approval of the clinical trial plan."

He explained, "We will conduct Phase 1 and 2 clinical trials simultaneously in the U.S. to prove the therapeutic efficacy for COVID-19 patients, and then proceed with procedures to administer it to large numbers of COVID-19 patients through treatment use approval or emergency use authorization. iCP-NI will be registered as a rescue therapeutic drug for severe and critical patients, and ultimately, the goal is to commercialize it as a standard treatment for COVID-19."