This designation is a significant milestone in the development of TUB-040, which is based on Tubulis’ proprietary P5 technology.
TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC with superior biophysical properties.
It has demonstrated effective and durable responses in preclinical models, including those for ovarian cancer.
The candidate is currently undergoing a multicentre Phase I/IIa study, NAPISTAR 1-01 (NCT06303505), focusing on patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who have exhausted other available treatment options.
Patients with ovarian cancer often develop resistance to platinum-based therapy, leaving them with limited and unsatisfactory therapeutic options.
Tubulis chief medical officer Günter Fingerle-Rowson commented, “The FDA´s Fast Track designation of TUB-040 is an important step in the development of TUB-040 to provide these women with urgently needed new therapeutic options.
“The FDA decision brings us one step closer to our goal of delivering the true value of ADCs to patients in need, and we are grateful for the agency’s support on this path to develop TUB-040 fast and efficiently.”
The ongoing Phase I/IIa study of TUB-040 is a multicentre, first-in-human trial that includes dose-escalation and optimization.
It aims to assess the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy.
The trial is being conducted across several countries, including the US, UK, Spain, Belgium, and Germany.
Phase Ia of the study is focused on dose escalation to determine the safety and the maximum tolerated dose or identified dose for optimisation. Phase IIa will concentrate on dose optimisation, safety, and preliminary efficacy assessments.