Tubulis to Present First Phase I/IIa Trial Data for ADC Candidate TUB-040 in Platinum-Resistant Ovarian Cancer in Late-Breaking Oral Presentation at ESMO 2025

MUNICH--(BUSINESS WIRE)--Tubulis today announced that its late-breaking abstract covering first clinical data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025, in Berlin. The presentation by the principal investigator of the study, Dr. Antonio Gonzalez-Martin, will provide interim data from the dose escalation part of the ovarian cancer cohort in the first-in-human study with TUB-040. Tubulis’ lead antibody-drug conjugate (ADC), TUB-040 is a next-generation NaPi2b-targeting ADC developed using Tubulis’ proprietary Tubutecan linker-payload platform. It combines the company’s P5 conjugation system with an exatecan payload enabling the development of stable, highly targeted ADCs, optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. In a range of preclinical models, including ovarian cancer, TUB-040 demonstrated superior biophysical properties as well as effective and durable responses.

Details of the oral presentation:

Title: NAPISTAR 1-01: A Phase 1 dose escalation study of TUB-040, a novel NaPi2b-targeting exatecan antibody-drug conjugate (ADC) in patients with platinum-resistant ovarian (PROC) high-grade serous carcinoma (HGSC)
Presenter: Dr. Antonio Gonzalez-Martin, Director Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra
Session Category and Title: Mini Oral session: Gynaecological cancers
Session Date and Time: October 19, 2025; 10:15 – 11:45 am CEST
Lecture Time: 10:38 – 10:43 am CEST
Location: Cologne Auditorium - CityCube A
Abstract Number: #5520

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

About Tubulis

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.