Biotechnology company Alligator Bioscience (Nasdaq Stockholm:ATORX) revealed on Thursday the submission of its clinical trial authorisation (CTA) application with the relevant regulatory authorities for the launch of a phase I cancer study of its wholly-owned bispecific drug candidate, ATOR-1015.
This upcoming phase I study of ATOR-1015 is a first-in-human dose escalation study in patients with advanced solid cancer. The study will be conducted at five sites in Sweden and Denmark. Theradex Oncology, a global contract research organisation, will conduct the phase I study.
The company said the primary aim of the phase I study is to investigate the safety and tolerability of ATOR-1015 in up to 50 patients and establish the recommended dose for the subsequent phase II studies.
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumour-directed immunotherapy with increased capability of regulatory T-cell depletion. ATOR-1015 binds to the checkpoint receptor CTLA-4 and the co-stimulatory receptor OX40. The immune activation is increased in areas where both target molecules are expressed at high levels, notably in the tumour micro-environment, which reduces adverse immune reactions, concluded the company.
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