The research involves patients with advanced solid malignancies on tumour-directed therapy

Alligator Bioscience has announced positive safety data from the 900mg dose cohort in its phase 1, first-in-human clinical trial with its drug candidate, ATOR-1017. The treatment is being developed as a tumour-directed therapy for advanced and metastatic cancer.

The data also demonstrates that, for doses up to 900mg, there were no significant safety concerns with the therapy, confirming previously announced signs of clinical benefit. Furthermore, no dose-limiting toxicity was observed and the maximum tolerated dose of ATOR-1017 has not been reached.

This phase 1 open-label dose-escalation study of ATOR-1017 in patients with histologically confirmed, advanced and/or refractory solid cancer has now completed enrolment while the primary objective of the study – to investigate the safety and tolerability of ATOR-1017 at therapeutic doses – has been successfully met. Two patients are still taking part in the study and are benefitting from ATOR-1017 treatment.

"We welcome the latest data from the 900mg dose cohort, the highest dose tested in this trial, which confirms the good safety profile of ATOR-1017," explained Søren Bregenholt, chief executive officer of Alligator Bioscience.

“We have observed activation of peripheral T-cells and increased levels of soluble 4-1BB across all active dose levels of ATOR-1017, demonstrating biological activity and proof of mechanism, further validating the therapeutic potential of this drug candidate in solid tumours. This phase 1 study has now successfully fulfilled its purpose and provides a strong foundation for further clinical development," he added.