Troubled Immunomedics tries again at FDA after rejection

Breast Cancer Cells
Breast cancer cells (National Cancer Institute)

Immunomedics has had a long and troubled road in the past few years that has included losing much of its C-suite after an FDA rejection, not to mention the strange failure of a $2 billion deal with Seattle Genetics.

Now, the biotech is hoping to reset after resubmitting its once-rejected antibody-drug conjugate IMMU-132 (sacituzumab govitecan) to the FDA.

The drug, which is seeking a license as a third-line treatment for late-stage, metastatic triple-negative breast cancer, was slapped with a complete response letter (CRL) at the start of the year the company said stemmed from manufacturing issues (but added there was no need for new clinical or preclinical data, which would have delayed things further).


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Things then got worse: When pressed by analysts after the CRL was made public, company executives dodged questions about whether the rejection stemmed from a preapproval inspection of its plant last year.

But then the FDA released the Form 483 from the inspection showing big issues with data integrity at the Morris Plains, New Jersey, plant where sacituzumab govitecan is being made.

The highly redacted, 13-observation missive says that during the inspection, investigators discovered serious data integrity issues including manipulation of bioburden samples, misrepresentation of a test procedure in the batch records and backdating of batch records, including the dates of analytical results.

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

This rejection and manipulation claims saw its CEO Michael Pehl hit the exit, swiftly followed by R&D lead Robert Iannone, M.D., who later joined Jazz Pharmaceuticals.

And this isn’t the first time its leader has walked, either: Back in 2017, a deal between Immunomedics and Seattle Genetics looked like it was in the bag, consisting of $2 billion in development and licensing focused on sacituzumab, including a hefty $250 million upfront.

But Seattle investors revolted, and the deal was axed, leading to the termination of Immunomedics’ then-CEO Cynthia Sullivan.

Now, the company is hoping for a reset on its highly tortuous path. Seemingly with the manufacturing issues resolved, it said in a very brief statement that it was announcing: “The resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”

“We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the Agency during the BLA review,” said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. “We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC.”

The biotech ended the day down 5% Wednesday, but was marginally up after-hours on the news.

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