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m4 Award winner Tubulis starts clinical trial with ADC TUB-030 for the treatment of solid tumours

Tubulis founder CEO Dr. Dominik Schumacher, (left) and CSO Dr. Jonas Helma-Smets © Tubulis

The Martinsried-based biotech company Tubulis has dosed the first patient in its Phase I/IIa study investigating the antibody drug conjugate (ADC) TUB-030. The compound targets the oncofetal antigen 5T4 and is based on the company's proprietary P5 conjugation technology. The trial is being conducted at several sites in the USA and Canada and is expected to enrol a total of 130 patients with advanced solid tumours.

As a spin-off of the Ludwig-Maximilians-Universität (LMU) Munich and the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) Berlin, Tubulis develops a pipeline of uniquely matched antibody drug conjugates (ADCs) with an indication-tailored targeting molecule and payload combination to develop novel ADCs with superior properties. The aim is to provide gentler and more efficient forms of therapy in the treatment of cancer. Tubulis won the m4 Award pre-seed competition coordinated by BioM prior to its company foundation.

TUB-030 targets the oncofetal antigen 5T4, which is expressed in a variety of solid tumours. The drug was developed using Tubulis' proprietary Tubutecan platform, which ensures precise and long-lasting drug release in tumour tissue. The conjugation system is based on the company's proprietary P5 technology and combines a humanised IgG1 antibody with the topoisomerase I inhibitor exatecan via a stable, cleavable linker.

Preclinical data presented at the AACR showed that TUB-030 induced strong and long-lasting tumour regression even at low 5T4 expression. In a mouse model for triple-negative breast cancer, a single treatment led to complete tumour remission.

The multicentre Phase I/IIa study is investigating the safety, tolerability, pharmacokinetics and efficacy of TUB-030 as monotherapy. Phase I dose escalation is intended to determine the maximum tolerated dose and a suitable dose for the optimisation phase. In Phase IIa, the compound will be further investigated with regard to safety and initial efficacy in selected tumour indications.

“This milestone for TUB-030 demonstrates our ability to execute on our strategy to advance innovative programs into our proprietary pipeline and rapidly bring them into the clinic,” said Dr. Dominik Schumacher, Chief Executive Officer and Co-founder of Tubulis. “As an organization, Tubulis has made a large step forward with two differentiated ADC molecules in clinical evaluation in less than a year. Our goal is to continue being an innovation driver in the field by delivering on the  transformative potential of our platforms for patients.”

With the evaluation of the ADC TUB-030, the company is adding another innovative drug candidate for the treatment of solid tumours to its clinical pipeline. In addition to TUB-030, the ADC candidate TUB-040 is also currently being investigated in a clinical trial.


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