Tubulis' Next-Gen ADC Shows Promise in Early Clinical Trial, Justifying Recent $361M Investment

Tubulis, a German biotech company, has unveiled promising early clinical data for its next-generation antibody-drug conjugate (ADC) at the European Society for Medical Oncology (ESMO) congress in Berlin. The results, which mark the first in-human data for the therapy, appear to validate the recent substantial investment in the company.

Impressive Clinical Results

TUB-040, Tubulis' NaPi2b-targeting ADC, demonstrated an overall response rate (ORR) of 59% in a phase 1/2a trial involving patients with platinum-resistant ovarian cancer and advanced non-small cell lung cancer. The study, which evaluated 66 patients across various dose cohorts ranging from 1.67 mg/kg to 3.3 mg/kg, also reported a confirmed disease control rate of 91% across all cohorts.

Notably, the onset of activity was observed at low doses, with 4.4 mg/kg identified as the maximum tolerated dose. This wide range of effective and tolerated doses suggests that physicians may have multiple options for treating patients with TUB-040.

Dr. Dominik Schumacher, CEO of Tubulis, expressed enthusiasm about the data, stating, "Our platform translated very nicely from pre-clinical to clinical." He emphasized the potential of the wide therapeutic window to "react to individual patients still being in an active range," which could potentially enhance the durability of responses.

Safety Profile and Future Plans

The trial data revealed a manageable safety profile for TUB-040. The most common treatment-related adverse events of grade 3 or above were neutropenia (22% of patients) and anemia (9%). Importantly, only two patients discontinued treatment due to adverse events, underscoring the therapy's tolerability.

Building on these encouraging results, Tubulis is now preparing to evaluate TUB-040 in earlier lines of treatment for ovarian cancer and explore other undisclosed solid tumor indications.

Financial Backing and Industry Partnerships

The clinical success comes on the heels of a substantial $361 million series C funding round, which positions Tubulis to pursue its expanding clinical ambitions. The company's ability to secure such significant investment is attributed to its strategy of "continuously talk[ing] to investors," according to CEO Schumacher.

While specific details about Big Pharma interest at ESMO were not disclosed, Tubulis maintains existing preclinical partnerships with industry giants Gilead and Bristol Myers Squibb. These collaborations are described as part of the company's business model, although Tubulis remains focused on advancing its fully-owned internal pipeline.