Amidst FDA Rejection, Immunomedics' CEO and President Steps Down

In addition to its fourth-quarter financial report, Morris Plains, NJ-based Immunomedics announced that its president, chief executive officer and board member, Michael Pehl, was stepping down for personal reasons.

The company also announced several changes to its executive lineup. Charles Baum, president and chief executive officer of Mirati Therapeutics, has joined the Immunomedics board of directors. Behzad Aghazadeh has been appointed executive chairman and Scott Canute, current member of the board, has been appointed executive director. Interim Chief Financial Officer Usama Malik has been appointed chief financial officer.

Pehl had only been on the job for 15 months.

On Jan. 17, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company’s Biologics License Application (BLA) for sacituzumab govitecan for metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two previous therapies.

At the time, Pehl stated, “We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients. The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated. We are going to request a meeting with the FDA as soon as possible to gain a full understanding of the Agency’s requirements and timelines for approval and we will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.”

On Dec. 17, 2018, the FDA cited Immunomedics for a number of problems, including a data integrity breach. The agency’s investigation found that Immunomedics’ quality control unit, according to the FDA, “didn’t have the authority to investigate critical deviations that occurred at the facility—namely a February 2018 data integrity breach, which didn’t trigger a deviation. This breach included a manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record, and backdating of batch records, such as dates of analytical results.”

In a statement, Aghazadeh noted, “I would like to thank Michael for his leadership and service to Immunomedics over the past fifteen months. We wish him all the best in his future endeavors as he returns to Europe. At the same time, we are honored to welcome Dr. Baum to our board. He has a storied career in drug development culminating in his role as President and CEO at Mirati, while also serving on the board of Array Biopharma. Dr. Baum brings a strong scientific, drug development, and executive management perspective that will be invaluable to Immunomedics as we continue to execute and expand on our development priorities.”

In the company’s conference call, Aghazadeh welcomed Scott Canute to the board, noting he had more than 36 years of biopharma industry experience, first at Eli Lilly, where he was president of Global Manufacturing, then later at Genzyme, where he was president of Manufacturing and Corporate Operations.

In terms of the FDA’s CRL, the company formed a CRL response team under Canute’s leadership and has reviewed all concerns and mapped out the company’s response. Aghazadeh stated, “The team is close to finalizing our response strategy in advance with the meeting request with the FDA. We have high confidence in our ability to respond to the issues and resubmit our BLA in the timely fashion. And that confidence is only increased as the CRL team began their work.”

At this point, they have not disclosed resubmission timelines.