Tubulis Receives FDA Fast Track Designation for Antibody-Drug Conjugate Candidate TUB-040 in Platinum-resistant Ovarian Cancer

CAR-T Digest - August 2020

27 June 2024: Tubulis Receives FDA Fast Track Designation for Antibody-Drug Conjugate Candidate TUB-040 in Platinum-resistant Ovarian Cancer

TUB-040 is a next-gen NaPi2b-targeting Exatecan ADC using proprietary P5 technology, now in a multicenter Phase I/IIa study (NAPISTAR 1-01)
P5 technology enables rapid creation of ultra-stable ADCs with unique linker stability, chemical flexibility, and homogenous DAR8 conjugation
TUB-040’s designation for platinum-resistant ovarian cancer is based on preclinical data showing superior biophysical properties and durable responses
Fast Track status allows increased interaction with the FDA to expedite TUB-040’s regulatory review
Ovarian cancer, the leading cause of death among gynecological cancers, has particularly poor outcomes in platinum-resistant cases