Express | A new generation of antibody-conjugated drugs obtained priority review by the FDA, Qilu Pharmaceutical has development rights in Greater China

▎The content team editor of WuXi AppTec today, Sesen Bio announced that the U.
S.
FDA has accepted the company’s biological product license application (BLA) for the innovative antibody conjugate drug Vicineum for the treatment of high-risk non-muscles that do not respond to BCG.
Invasive bladder cancer (NMIBC).

The FDA also granted this BLA priority review qualification and is expected to respond before August 18 this year.

Vicineum is an antibody-conjugated drug (ADC) targeting Epithelial Cell Adhesion Molecule (EpCAM).

In July last year, Qilu Pharmaceutical and Sesen Bio reached an exclusive license agreement to obtain Vicineum's exclusive development rights in Greater China for the treatment of non-muscle invasive bladder cancer and other cancer types that did not respond to Bacille Calmette-Guerin (BCG).

Bladder cancer is one of the common cancer types, and about 80% of patients are NMIBC.

In this type of disease, cancer cells are located in the bladder or have grown into the bladder cavity, but have not spread to muscles or other tissues.

NMIBC mainly affects men, and it is related to exposure to carcinogens.

Patients receiving initial surgical resection have a high recurrence rate, and more than 60% of patients will receive Bacille Calmette-Guerin (BCG) immunotherapy.

Although BCG is effective in many patients, tolerability issues have been observed, and many patients experience disease recurrence.

If BCG is ineffective or the patient needs to receive BCG for a long time, the recommended treatment plan is to completely remove the bladder.

Vicineum is a next-generation ADC drug developed using Sesen Bio's proprietary targeted protein therapy platform.

It will target the EpCAM antibody fragment on the surface of tumor cells, and the cytotoxic Pseudomonas exotoxin A (ETA), which is linked through a stable genetically engineered polypeptide.

EpCAM is highly expressed on the surface of NMIBC cells, but the expression level is very low or not expressed in normal cells.

The advantage of this ADC is that it has a small molecular weight, which can promote tumor penetration and drug delivery.

Moreover, it has a dual mechanism of action.
In addition to targeted killing of tumor cells through cytotoxic load, the killed cells can also activate T cell-mediated anti-cancer immune responses.

Previously published clinical data showed that after 3 months of treatment, the complete remission rate (CRR) of patients with high-risk NMIBC carcinoma in situ (CIS) reached 40%, and the recurrence-free rate of patients with NMIBC papillary carcinoma reached 71%.

76% of patients do not need to completely remove the bladder within 3 years.

▲Vicineum's clinical efficacy and safety data (picture source: reference [2]) Sesen Bio said that in the next 1-2 months, the company is expected to submit a regulatory application to the European Union.

At the same time, Qilu Pharmaceutical is expected to announce the latest progress of Vicineum's IND application in China.

Note: This article is intended to introduce medical and health research, not to recommend treatment options.

If you need guidance on treatment plans, please go to a regular hospital for treatment.

Reference: [1] Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum™.
Retrieved February 16, 2021, from https:// Bio-Announces-FDA-Acceptance-and-Priority-Review-of-its-Biologics-License-Application-for-Vicineum%E2%84%A2[2] Seseon Bio, January business update.
Retrieved February 16, 2021, from https://ir.
sesenbio.
com/static-files/01a0654e-e427-4f9e-b953-f3e17f8c44eb