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Tubulis and Bristol Myers Squibb Advance First Collaborative Tubutecan ADC into Clinical Trials

• Tubulis announced that the first antibody-drug conjugate from its strategic partnership with Bristol Myers Squibb has entered clinical development, marking a significant milestone in their 2023 collaboration agreement.

• The ADC candidate leverages Tubulis' proprietary Tubutecan technology, which combines their P5 conjugation system with an exatecan payload to create stable, targeted cancer therapeutics with minimized systemic toxicity.

• This represents the third Tubutecan-based ADC to reach clinical trials within 12 months, following Tubulis' wholly owned programs TUB-030 and TUB-040, demonstrating the platform's versatility for treating solid tumors.

Tubulis today announced a significant advancement in its strategic collaboration with Bristol Myers Squibb (BMS) as the first antibody-drug conjugate (ADC) program from their partnership has entered clinical development. This milestone comes less than two years after the companies established their agreement in 2023 to develop next-generation ADCs for cancer treatment.
The clinical-stage program, licensed exclusively to BMS, represents the third ADC candidate utilizing Tubulis' proprietary Tubutecan technology to reach the clinic within just 12 months. This achievement highlights the rapid translation of the company's innovative ADC platform into potential therapeutic options for cancer patients.
"Within two years, this collaboration has advanced an exciting ADC candidate into the clinic, and we remain highly committed to this robust and valuable partnership," said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. "Having brought three Tubutecan-based ADC candidates into the clinic within just 12 months, including our wholly owned programs TUB-030 and TUB-040, we are continuing to demonstrate the versatility and translational potential of our technologies in delivering more effective cancer therapeutics."

Innovative Technology Platform

The Tubutecan technology at the core of this collaboration combines Tubulis' P5 conjugation system with an exatecan payload. This proprietary approach enables the development of stable, highly targeted ADCs optimized for the on-target delivery of topoisomerase-1 inhibitors while minimizing systemic toxicity—a critical factor in improving the therapeutic window of ADC treatments.
These next-generation ADC candidates are specifically designed to overcome key limitations of earlier ADC platforms, potentially offering new therapeutic opportunities for patients with aggressive and difficult-to-treat solid tumors.

Strategic Partnership Details

The 2023 agreement between Tubulis and BMS was established to leverage complementary expertise: Bristol Myers Squibb's extensive oncology and clinical development capabilities combined with Tubulis' innovative approach to ADC design. The collaboration focuses on developing a selected number of highly differentiated ADCs targeting solid tumors.
Under the terms of the collaboration, BMS holds exclusive rights to develop and commercialize selected ADCs using the Tubutecan platform. In return, Tubulis is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on any resulting marketed products.

Expanding ADC Pipeline

Beyond this BMS collaboration, Tubulis is advancing its wholly owned pipeline of ADC candidates. The company's lead programs include TUB-040, which targets NaPi2b, and TUB-030, directed against 5T4. Both candidates are currently being evaluated in clinical trials for high-need solid tumor indications.
Tubulis has positioned itself as an emerging leader in the rapidly evolving ADC field by developing conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models.
The advancement of this third clinical candidate within a year underscores the potential of Tubulis' platform technologies to expand the therapeutic potential of the ADC drug class for both its internal pipeline and external partnerships, ultimately aiming to deliver more effective treatment options for cancer patients.
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