Tubulis' Next-Gen ADC Shows Promise in Early Clinical Trial, Boosting Investor Confidence

In a significant development for the antibody-drug conjugate (ADC) field, German biotech company Tubulis has revealed promising early clinical data for its next-generation ADC, TUB-040. The results, presented at the European Society for Medical Oncology (ESMO) congress in Berlin, have justified recent investor interest and could potentially reshape the landscape of cancer treatment.

Impressive Clinical Results

TUB-040, which targets NaPi2b, 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 included 66 evaluable patients who had received a median of four prior lines of therapy, showed activity across a range of doses from 1.67 mg/kg to 3.3 mg/kg.

Notably, the onset of activity was observed at low doses, with 4.4 mg/kg identified as the maximum tolerated dose. The confirmed disease control rate reached an impressive 91% across all cohorts by the September 1 data cut-off.

Safety Profile and Therapeutic Window

TUB-040's safety profile appears promising, with manageable side effects. 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 ADC's tolerability.

Tubulis CEO Dominik Schumacher, Ph.D., emphasized the significance of the wide therapeutic window, stating, "We believe that having a wide therapeutic window where you can react to individual patients still being in an active range can help to facilitate [improved durability of responses]."

Technology Platform and Future Plans

The encouraging results stem from Tubulis' proprietary Tubutecan platform, which combines therapeutic payloads with P5 conjugation technology. This approach aims to reduce toxicity by preventing premature payload loss and aggregation in circulation, potentially offering an advantage over traditional ADCs.

Building on these positive findings, Tubulis is preparing to evaluate TUB-040 in earlier lines of treatment for ovarian cancer and explore its potential in other solid tumor indications. The company's expansion plans are supported by a recent $361 million Series C funding round, demonstrating strong investor confidence in Tubulis' technology and pipeline.