Lund, Sweden, May 16, 2019 – Alligator Bioscience (Nasdaq Stockholm: ATORX), today announces that the outline of the ongoing Phase I study with the bispecific drug candidate ATOR-1015 will be showcased at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago on May 31- June 4, 2019.
The ATOR-1015 Phase I study is a first-in-human dose-escalation study in patients with advanced solid malignancies (NCT03782467). The primary aim of the study is to investigate the safety and tolerability of ATOR-1015 and to identify the maximum tolerated dose/recommended dose for subsequent Phase II studies. The first patient was dosed in March 2019 and the study results are expected to read out in the second half of 2020.
The study design includes accelerated dose titration with one patient cohorts, followed by a modified 3+3 design with at least three patients per dose level. At the maximum tolerated dose, or at a lower dose level, an expansion cohort is planned with up to 14 patients, for additional safety and efficacy evaluation.
Charlotte Russell, Chief Medical Officer at Alligator Bioscience will present the poster (#292b) entitled “A first-in-human, multicenter, open-label, phase I study in patients with advanced and/or refractory solid malignancies to evaluate the safety of intravenously administered ATOR-1015” by Jeffrey Yachnin et al. on June 1 from 8-11 a.m. CDT in the session Developmental Immunotherapy and Tumor Immunobiology.
“While immune activation through CTLA-4 has shown impressive efficacy in multiple cancers, it is coupled with severe toxicity. We believe that ATOR-1015 will be at least as effective as the approved monospecific CTLA-4 antibody and with less side effects,” said Per Norlén, CEO of Alligator Bioscience.
For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
This information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CEST (2:30 a.m. EDT) on May 16, 2019.
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.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes five lead clinical and preclinical drug candidates: ADC-1013, ATOR-1015, ATOR-1017, ALG.APV-527 and ATOR-1144. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 55 employees. For more information, please visit http://www.alligatorbioscience.com.
ADC-1013 (JNJ-7107) is licensed to Janssen Biotech, Inc. for global development and commercialization.