Clinical Trials

Date: 2018-07-19

Type of information: Submission of a clinical trial application

phase: 1

Announcement: submission of a clinical trial application

Company: Alligator Bioscience (Sweden)

Product: ATOR-1015

Action mechanism:

bispecific antibody/immune checkpoint inhibitor. ATOR-1015 is a bispecific antibody for tumor-directed immunotherapy and is fully owned and developed by Alligator for the treatment of metastatic cancer. ATOR-1015 binds to two different immune receptors: the checkpoint receptor CTLA-4, and the co-stimulatory receptor OX40. ATOR-1015 is developed to reduce immune suppressive functions including regulatory T cells, as well as to induce direct T-cell activation. The immune activation is augmented in areas where both target molecules are expressed at high levels, notably in the tumor microenvironment, which is believed to reduce adverse immune reactions.

Disease:

Therapeutic area: Cancer - Oncology

Country: Denmark, Sweden

Trial details:

Latest news:

• On July 19, 2018, Alligator Bioscience announced that the company has submitted a clinical trial authorization (CTA) application to the relevant regulatory authorities to start a phase I study of its wholly-owned bispecific drug candidate ATOR-1015.
The upcoming phase I study with 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 and will enroll 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. ATOR-1015 is intended to be the first CTLA-4 and OX40-binding bispecific antibody to achieve a strong anti-tumor 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.
As previously communicated, Alligator has appointed Theradex Oncology, a global contract research organization with extensive expertise in oncology clinical development, to conduct the phase I study.