A new generation of antibody-coupled drugs is eligible for FDA priority review

Bladder cancer is one of the most common types of cancer, with about 80% of patients in NMIBC.
in these diseases, cancer cells are located in the bladder or have developed into the inner cavity of the bladder, but have not yet spread to muscles or other tissues.
NMIBC mainly affects men and is associated with exposure to carcinogens.
patients undergoing initial surgical excision have a high recurrence rate, and more than 60% of patients will receive BCG immunotherapy.
BCG is effective in many patients, tolerance problems have been observed and many patients experience a recurrence of the disease.
if BCG is ineffective or if the patient needs to receive BCG for a long time, the recommended treatment is a complete removal of the bladder.
Vicineum is a next-generation ADC drug developed using Sesen Bio's proprietary targeted protein therapy platform.
it connects the antibody fragments of EpCAM, which targets the surface of tumor cells, to the cytotoxic loaded protobacterial extratoxin A (ETA) through stable genetically engineered peptides.
expressed at a high level on the surface of NMIBC cells, but at very low or non-expression levels in normal cells.
advantage of this ADC is that it has a small molecular weight and can promote tumor penetration and drug delivery.
it has a dual mechanism that, in addition to targeting tumor cells through cytotoxic loads, can activate T-cell-mediated anti-cancer immune responses.
previously published clinical data show that after three months of treatment, the rate of complete remission (CRR) in patients with high-risk NMIBC in-place cancer (CIS) reached 40%, and the rate of non-recurrence of NMIBC papicular cancer reached 71%.
76% of patients do not need to have their bladder completely removed within three years.
Sesen Bio said it expected to submit regulatory applications to the EU over the next 1-2 months.
, Qilu Pharmaceuticals is expected to announce the latest developments in Vicineum's IND application in China.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
resources: sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for vicinity ™. Retrieved February 16, 2021, from [2] Seseon Bio, January business update. Retrieved February 16, 2021, from