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Tubulis, a company spun off from the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) and LMU Munich in 2019, has announced positive early clinical data from the Phase I/IIa NAPISTAR1-01 study (NCT06303505). The data demonstrate robust clinical efficacy with a favourable safety profile and excellent tolerability in heavily pretreated patients with ovarian cancer.
The data were first presented in a lecture at the European Society for Medical Oncology (ESMO) Congress in Berlin. Study leader Dr Antonio Gonzalez-Martin, Director of the Department of Oncology at the Clínica Universidad de Navarra, presented the results of the leading antibody-drug conjugate (ADC) TUB-040 in platinum-resistant high-grade serous ovarian cancer (PROC-HGSOC), focusing on doses between 1.67 and 3.3 mg/kg. This is the first time that clinical data has been available to validate Tubulis' proprietary Tubutecan technology and provide proof of concept for the company's most advanced ADC targeting NaPi2b.
Tubulis relies on innovative P5 conjugation technology in its product development, which plays a key role in the manufacture of its ADCs. This linker chemistry was developed in basic research by Prof. Christian Hackenberger, one of the co-founders of Tubulis, and his team at the FMP and further developed by Tubulis for clinical research, enabling stable, targeted drug delivery.
“These positive initial clinical results for TUB-040 mark a milestone for Tubulis, confirm our ADC design strategy and offer a potentially new therapeutic option for patients with platinum-resistant ovarian cancer”, said Dr Dominik Schumacher, Chief Executive Officer and co-founder of Tubulis. “Supported by our recent financing round, we are in a position to rapidly advance TUB-040 into pivotal trials and expand clinical development to earlier disease stages and additional tumor types. With these data, we are laying the foundation to fully exploit the potential of ADCs based on our Tubutecan platform and help patients even more effectively."
Tubulis recently completed a Series C financing round of €308 million (US$361 million) – the largest of its kind for a European biotechnology company in a Series C round and also the largest financing ever for a private ADC (antibody-drug conjugate) company worldwide. The round was led by Venrock Healthcare Capital Partners, with participation from new investors such as Wellington Management and Ascenta Capital, as well as existing investors.
Clinical Highlights:
By 1 September 2025, 67 patients with platinum-resistant ovarian cancer had been treated with TUB-040, 46 of them in dose cohorts ranging from 1.67 to 3.3 mg/kg. The average age was 62 years. The objective response rate (ORR) was 59%, and the confirmed ORR was 50%. Complete remission was documented at 2.5 mg/kg. The disease control rate was 96%, with 81% of patients showing a positive response to the CA-125 tumour marker. Treatment is still ongoing in 80% of patients. Patients who had previously been treated with mirvetuximab soravtansin also responded to TUB-040.
TUB-040 was well tolerated, with predominantly mild to moderate side effects. There were no treatment-related deaths in any cohort and no discontinuations of treatment in the relevant dose cohorts. Clinically relevant complications such as bleeding, pneumonitis or nerve damage did not occur, which distinguishes TUB-040 from other similar agents in this class. Its low and manageable toxicity is also noteworthy. Serious side effects (grade 3 or higher) were rare, including neutropenia (22%), anaemia (9%), thrombocytopenia (4%) and nausea (4%).
"The interim results show a differentiated clinical profile for TUB-040 with anti-tumour activity and a broad therapeutic window, which could offer treating physicians flexibility in dosing. The data confirm NaPi2b as a valuable ADC target and demonstrate that our Tubutecan technology enables effective tumour response with reduced toxicity. Our goal now is to further accelerate the clinical development of TUB-040 in order to bring this valuable drug to patients as quickly as possible," explains Dr Günter Fingerle-Rowson, Chief Medical Officer of Tubulis.
The ongoing NAPISTAR 1-01 study (NCT06303505) is investigating TUB-040 and aims to assess the safety, tolerability, pharmacokinetics and efficacy of TUB-040 as monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or recurrent/refractory adenocarcinoma of non-small cell lung cancer (NSCLC). Based on the promising results, Tubulis plans to initiate pivotal studies. refractory adenocarcinoma of non-small cell lung cancer (NSCLC). Based on the promising results, Tubulis plans to initiate pivotal studies and evaluate the candidate in earlier lines of therapy in ovarian cancer, as well as explore its inclusion in combination therapies and new solid tumour indications. The first data from the NSCLC cohort will be presented at a future medical conference.
About TUB-040 and Tubutecan technology
Tubulis' lead antibody-drug conjugate (ADC), TUB-040, targets NaPi2b, an antigen that is highly overexpressed in ovarian cancer and lung adenocarcinoma. It consists of an IgG1 antibody targeting NaPi2b and equipped with Tubulis' proprietary Tubutecan technology, whereby the topoisomerase I inhibitor exatecan is coupled via a cleavable linker system based on the company's proprietary P5 conjugation technology and with a homogeneous DAR of 8. Using novel chemistry for cysteine-selective conjugation developed at FMP Berlin, the technology enables the development of stable, highly targeted ADCs that are optimised for the targeted delivery of the topoisomerase I inhibitor while minimising systemic toxicity.
About Tubulis
Tubulis develops tailor-made antibody-drug conjugates (ADCs) with improved biophysical properties. In preclinical models, the ADCs have already demonstrated targeted and sustained accumulation in tumours as well as long-lasting anti-tumour effects. The two most advanced programmes in the growing pipeline are TUB-040 (targeting NaPi2b) and TUB-030 (targeting 5T4). Both programmes are currently being investigated in clinical trials for cancers with high unmet medical needs. For more information, visit: www.tubulis.com
Prof. Dr. Christian Hackenberger
Group leader Biomolecule Modification and delivery
Leibniz- Forschungsinstitut für Molekulare Pharmakologie (FMP)
Email: hackenbe@fmp-berlin.de
For Tubulis:
Dr. Dominik Schumacher
CEO and co-founder
Phone: +49 175 800 5594
Email: contact@tubulis.com
P5 conjugation technology as a molecular glue to construct antibody-drug-conjugates (ADCs) for clini ...
Quelle: Barth van Rossum
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P5 conjugation technology as a molecular glue to construct antibody-drug-conjugates (ADCs) for clini ...
Quelle: Barth van Rossum
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