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Alligator Bioscience starts clinical phase I study
Regulatory approvals have been obtained for the first clinical study of ATOR-1015 and patient recruitment can now be initiated.
ATOR-1015 is a wholly-owned drug candidate developed for tumor-directed immunotherapy.
A first-in-human dose-escalation study
The phase I study is a first-in-human dose-escalation study in up to 53 patients with advanced solid tumor disease at five different clinics across Sweden and Denmark. The primary aim of the study will be to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent Phase II studies.
“The start of clinical phase I study with ATOR-1015 represents a significant milestone for Alligator. We are first in the world with a new concept, a tumor-localizing bispecific CTLA-4 antibody. While the target is clinically validated, the clinical use of CTLA-4 blocking agents is restricted by severe toxicity. ATOR-1015 may provide a solution through its potential for selective activation of the immune system in the tumor area but not elsewhere in the body. The drug’s preclinical results are very promising, clearly supporting this concept,” said Per Norlén, CEO of Alligator Bioscience.
Photo of Per Norlén: Jenny Leyman
Published: December 20, 2018