CDE China Grants IND Approval For Vicineum Of Sesen Bio Inc (NASDAQ:SESN)

Sesen Bio Inc (NASDAQ:SESN) is pleased to announce the receipt of IND approval for its innovative drug – Vicineum, from CDE (Center Drug Evaluation), China, before the scheduled timeline.

The company previously sought IND for its Vicineum through its partner – Qilu Pharmaceutical, based in China. Vicineum will be used to treat BCG-unresponsive NMIBC (non-muscle invasive bladder cancer).

Evaluates safety and efficacy of Vicineum

The IND approval allows Qilu can commence the clinical trial to evaluate the Vicineum for its safety and efficacy in Chinese patients with BCG-unresponsive NMIBC. Qilu will bear all the trial costs of Vicineum in China.

Qilu will seek market authorization in 2022 after the successful completion of the clinical trial of Vicineum. It will apply for potential approval of the drug in China in 2023.

Sesen Bio’s CEO, Thomas Cannell, staed the company accomplished a major milestone by receiving IND approval. It can improve and save the lives of several patients across the world.

The usage of Vicineum to treat BCG-unresponsive NMIBC in Chinese patients is minimal compared to the US. It offers immense potential for this drug in overseas markets.

The early IND approval for Vicineum is on the backdrop of healthy collaboration between Qilu and Sesen Bio.

Sesen Bio is already armed with the data obtained from a successful Phase 3 clinical trial of Vicineum in the US. It also maintains a team of experienced oncology professionals and hopes to achieve success in the Chinese Clinical trial and seek quick submission.

Thomas said the company would continue to work with NMPA (National Medical Products Administration) of China and Qilu to provide Chinese patients with best-in-class medicine.

Milestone payments

Sesen Bio will receive $3 million of the $23 million milestone payments from Qilu as part of the collaboration pact. The market for Vicineum expects to reach up to $418 million in China.

TOT in 2021

Sesen Bio will include Qilu for its worldwide distribution of Vicineum. The company expects to complete TOT (Technology Transfer) for Vicineum in 2021 to Qilu and will qualify for an additional payment of $2 million.

The locally administered FP (fusion protein) – Vicineum is developed to cure BCG-unresponsive NMIBC.

Vicineum comprises a recombinant fusion protein targeting EpCAM (epithelial cell adhesion molecule) antigens on tumor cells surface to deliver Pseudomonas Exotoxin A. It is a GE (genetically engineered) peptide tether binding the payload until internalized by the cancer cell.Therefore, Vicineum can minimize toxicity risk to healthy tissues and improves safety.