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ImmunityBio Wins FDA Approval for Clinical Testing of Cancer-Fighting Drug

Shares of Culver City-based ImmunityBio, Inc. shot up nearly 10% on May 17 after the immunotherapy company announced it had received FDA authorization to launch clinical studies of a key cancer-fighting drug in its platform.

The U.S. Food and Drug Administration authorized ImmunityBio to conduct a Phase I clinical trial to evaluate the safety and preliminary effectiveness of what the company calls its “killer cell” drug.

The cancer treatment is derived from a patient’s own blood that has enhanced ability to recognize and kill cancer tumor cells. This killer cell is combined with a receptor enhancer that eases the pathway for the killer cell to enter invading pathogen cells.

This drug combination would be used to treat people with advanced or metastatic solid tumors.

“We are excited to launch this next evolution of our NK platform,” Patrick Soon-Shiong, founder and executive chairman of ImmunityBio, said in the announcement. “Nearly two million Americans, including children, will be diagnosed with locally advanced or metastatic solid tumors this year alone and many of these tumor types are difficult to treat.”

Soon-Shiong added that “our m-ceNK cells, which are isolated and enriched from the patient after a simple blood draw are characterized by … their highly desirable feature of immune memory and marked by their pronounced anti-cancer activity for weeks to months in duration.”

The Phase 1 clinical study will test two cohorts of 10 people to evaluate safety in subjects with locally advanced or metastatic solid tumors. 

The study will compare the quantity and quality of the natural killer cells collected and manufactured from newly diagnosed patients who have not received prior treatment to the m-ceNK cells collected and manufactured from patients who have received at least two prior treatments for their cancer.

No timeline was announced for completion of this Phase 1 study. If the study is concluded successfully, then ImmunityBio’s drug combination must still undergo more rigorous Phase 2 and Phase 3 clinical trials before it can be considered for approval and use.

Shares of ImmunityBio rose 9.7% on May 17 to close at $16.59.

Howard Fine
Howard Fine
Howard Fine is a 23-year veteran of the Los Angeles Business Journal. He covers stories pertaining to healthcare, biomedicine, energy, engineering, construction, and infrastructure. He has won several awards, including Best Body of Work for a single reporter from the Alliance of Area Business Publishers and Distinguished Journalist of the Year from the Society of Professional Journalists.
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