On December 11, 2018 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) reported that 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 (Press release, Alligator Bioscience, DEC 11, 2018, View Source [SID1234538673]).
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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.
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.
For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]
This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on December 11, 2018.
About ATOR-1015
ATOR-1015 is a next generation CTLA-4 bispecific antibody developed for tumor-directed immunotherapy with increased capability of regulatory T-cell depletion. It is wholly-owned by Alligator. ATOR-1015 binds to two different immune receptors: 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 tumor microenvironment, which is believed to reduce adverse immune reactions.