Alligator Bioscience (STO:ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumour -directed immunotherapy, announced on Thursday the submission by the company of a clinical trial authorisation (CTA) application to the relevant regulatory authorities to start a phase I study of its wholly-owned bispecific drug candidate ATOR-1015.

Reportedly, this upcoming phase I study with ATOR-1015 is a first-in-human dose escalation study in patients with advanced solid cancer. This study will be conducted at five sites in Sweden and Denmark and will enrol up to 50 patients. The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and establish the recommended dose for the subsequent phase II studies.

According to the company, ATOR-1015 is intended to be the first CTLA-4 and OX40-binding bispecific antibody to achieve a strong anti-tumour effect, either as a monotherapy or in combination with currently established immunotherapies such as PD-1 and PD-L1 blockers. It is expected to be suitable for treating a large number of different forms of cancer.

Also, the company is looking forward to starting patient recruitment as fast as possible after regulatory approval. Based on a strong preclinical data package demonstrating that ATOR-1015 localises to the tumour and selectively activates the immune system in the tumour area, the company has high expectations of this first-in-class drug candidate.

Alligator has appointed Theradex Oncology, a contract research organisation with extensive expertise in oncology clinical development, to conduct the phase I study.