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Alligator Bioscience submits clinical trial application

The company has submitted clinical trial authorization (CTA) application to initiate a Phase I study of its fully owned 4-1BB antibody ATOR-1017 for the treatment of metastasizing cancer.

ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity to detect and kill tumor cells, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 has a unique profile related to the fact that its immunostimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation, while minimizing side effects for the patient.

Phase I study

The upcoming Phase I study will be a first-in-human, dose escalation study in patients with advanced cancer. It will be conducted at 3 sites in Sweden and will enroll up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

“We look forward to begin patient recruitment following approval of the ATOR-1017 application by regulators. Our data support its potential to generate a potent and long-lasting immune response or even to induce immunity to cancer, while minimizing side effects through tumor-directed immune activation. This will be the third of our drug candidates to enter the clinic, as we continue to make great progress developing the next generation of cancer immunotherapies,” said Per Norlén, CEO of Alligator Bioscience.

Photo of Per Norlén: Jenny Leyman