Immunomedics nabs J&J veteran for CMO as it presses on with ADC redo

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Loretta Itri arrives at Immunomedics one year after the FDA rejected the application for sacituzumab govitecan as a third-line treatment for late-stage, metastatic triple-negative breast cancer. (Pixabay)

For the last year, biopharma veteran Loretta Itri, M.D. has been helping Immunomedics out with its troubled antibody-drug conjugate, sacituzumab govitecan. Now, she’s signing on with the company full-time as its new chief medical officer. 

Itri joins from The Medicines Company, where she oversaw global health sciences and medical affairs. Before that, she was chief medical officer and president of pharmaceutical development at Genta, a cancer-focused biotech that went bankrupt in 2012, and spent 11 years at Johnson & Johnson, where, as a senior vice president, she ran the medical and regulatory affairs unit and then the worldwide clinical affairs team. 

She's arriving a year after the FDA rejected the application for sacituzumab govitecan as a third-line treatment for late-stage, metastatic triple-negative breast cancer. As if that wasn’t bad enough, the agency followed up with results from a preapproval inspection of Immunomedics’ manufacturing plant showing the company manipulated data and misrepresented test procedures. The CEO and chief medical officer at the time, Michael Pehl and Robert Iannone, M.D., jumped ship soon after. 

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RELATED: Troubled Immunomedics tries again at FDA after rejection 

Immunomedics is getting a second chance though—the FDA accepted its resubmission of Biologics License Application for sacituzumab govitecan in December and Itri is on board to lead research, clinical development, regulatory and medical affairs for the antibody-drug conjugate, as well as for earlier-stage programs. 

RELATED: Iannone walks out on troubled Immunomedics a year after taking CMO job

“Working closely with the FDA, we are hopeful that sacituzumab govitecan will soon be available to patients with triple-negative breast cancer,” Itri said in a statement. “I am especially looking forward to working closely with the executive management team to expand our clinical development plans across our unique ADC platform to advance therapeutic options across hard-to-treat cancers, including indications such as metastatic urothelial cancer and hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer.” 

Immunomedics has teamed up with AstraZeneca to develop sacituzumab govitecan in earlier lines of treatment of metastatic triple-negative breast cancer. The duo is also testing the ADC on its own in advanced bladder cancer, and in combination with a checkpoint inhibitor in non-small cell lung cancer.

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