Sesen Bio Strengthens Medical Team

Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the strengthening of its medical team with the hiring of Dominika Kowalski as Senior Director of Global Drug Safety. Ms. Kowalski’s hiring demonstrates Sesen Bio’s strong commitment to and continued focus on the development of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.

“We are excited for Dominika to join our team as we continue to engage with the FDA and work toward advancing our lead product candidate,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Dominika has the right experience to support our mission of saving and improving the lives of patients, and her hiring further demonstrates our commitment to working to bring new treatment options to market.”

Ms. Kowalski brings over 14 years of drug safety experience in the pharmaceutical industry supporting both marketed and investigational products. She previously worked at Horizon Therapeutics, Abbott and AbbVie, where she managed safety surveillance, preparation of periodic safety reports and adherence to local and global authority requirements. Over the course of her career, Ms. Kowalski has worked on evaluation of the overall safety profile for products in clinical development, products approved by the US Food and Drug Administration (FDA) and products marketed under foreign regulatory authorities.

Ms. Kowalski holds a Master of Science degree in Public Health Nursing and a Post-Master Degree for Pediatric Nurse Practitioners from Rush University and a Bachelor of Science in Nursing from University of Illinois. She holds active licensure as a Pediatric Nurse Practitioner, and prior to joining the pharmaceutical industry, Ms. Kowalski worked as a study coordinator on HIV clinical trials and as a Pediatric Nurse Practitioner.

As previously disclosed, on October 29, 2021, Sesen Bio participated in a productive Type A meeting with the FDA to discuss questions related to chemistry, manufacturing and controls (CMC) raised in the FDA’s Complete Response Letter (CRL) regarding the Company’s Biologics License Application (BLA) for Vicineum. The Company believes it has a clear understanding of what additional information regarding CMC is required for resubmission of the BLA. Additionally, as disclosed on November 18, 2021, a separate Type A meeting to discuss recommendations specific to additional clinical/statistical data and analyses raised in the CRL is scheduled for December 8, 2021.