Qilu Pharmaceutical's $35M In-Licensed ADC Vicinium Receives IND Approval in China for NMIBC

On March 19, the CDE website indicated that Qilu Pharmaceutical’s Vicinium (oportuzumab monatox, VB4-845) had received automatic approval for clinical trials, intended for the treatment of non-muscle-invasive bladder cancer.

Vicinium is a next-generation antibody-drug conjugate (ADC) developed by Sesen Bio. It is a recombinant fusion protein that, on one hand, targets the epithelial cell adhesion molecule (EpCAM) antigen on the surface of tumor cells and delivers Pseudomonas exotoxin A (ETA) into these cells; on the other hand, it stimulates the host’s autoimmune response through T-cell recognition of neoantigens, thereby killing tumor cells.

On July 31, 2020, Qilu Pharmaceutical entered into an exclusive licensing agreement with Sesen Bio, securing the exclusive rights to develop and commercialize Vicinum in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan). Vicinum is intended for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) as well as other types of cancer. The total value of this collaboration transaction was $35 million.

In August 2020, Sesen Bio announced the Phase III VISTA study data for Vicineum in patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), specifically carcinoma in situ (CIS) or papillary tumors. The results showed that in Cohort 1, comprising patients with CIS refractory to or recurring within 6 months after BCG therapy, the 12-month complete response rate was 17%, with a median duration of response of 273 days. In Cohort 2, comprising patients with CIS recurring 6–11 months after BCG therapy, the 12-month complete response rate was 14%. Among all treated patients (n=133), 90% had a progression-free survival of ≥2 years.

Based on the above positive data, Sesen Bio’s New Drug Application (NDA) submitted to the FDA was accepted in February 2021 and granted Priority Review, with a PDUFA date of August 18, 2021.