Benzinga | Jul 20, 2021 09:43AM EDT

Sesen Bio, Qilu Pharmaceutical Announce Enrollment Of First Patient In Clinical Trial For Vicineum In China

Sesen Bio (NASDAQ:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, and its partner in Greater China, Qilu Pharmaceutical, announced today that the first patient has been enrolled in China in the clinical trial to assess the efficacy and safety of Vicineum in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The milestone comes only four months after the Investigational New Drug (IND) application for Vicineum was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), which triggered a $3M milestone payment from Qilu Pharmaceutical, the first of $23M in potential milestone payments to Sesen Bio.

"The enrollment of the first patient in the clinical trial in China is a significant milestone in realizing our mission to save and improve the lives of patients globally," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu Pharmaceutical has strong clinical and regulatory experience, and we are encouraged by the speed in which Qilu Pharmaceutical is moving forward with its clinical and regulatory efforts. We look forward to working closely with Qilu Pharmaceutical in the coming months as we continue to make progress in bringing Vicineum to market in China."

"We continue to believe in the differentiated clinical profile of Vicineum and its potential to address a significant unmet need in the treatment of BCG-unresponsive NMIBC in the Greater China region," said Oliver Kong, M.D., chief medical officer and corporate vice president of Qilu Pharmaceutical. "We look forward to completing enrollment of the trial, and to working with the NMPA to potentially bring Vicineum to market to make a meaningful impact on the lives of patients."

The open-label, single-arm, multi-center bridging trial will evaluate the efficacy and safety of Vicineum in approximately 53 patients with carcinoma in situ (CIS) with or without papillary disease, high-grade Ta papillary disease or T1 papillary disease of any grade. Patients will be required to have failed previous treatment with BCG for inclusion in the trial. The primary endpoints are the complete response rate (for CIS patients) and the recurrence-free rate (for papillary patients) at six months, with the complete response rate and the recurrence-free rate at three months, safety and tolerability as the secondary endpoints. Based on the partnership agreement between Sesen Bio and Qilu Pharmaceutical, the trial is being run at the sole cost of Qilu Pharmaceutical.

Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in China in 2022, with potential approval expected in 2023. Sesen Bio believes China represents a large potential market for Vicineum, with unadjusted peak year sales estimated at $155M-$418M.

In the US, the Company believes it remains on track for an FDA decision on its Biologics License Application for Vicineum by the target PDUFA date of August 18, 2021.