LUND, Sweden I July 19, 2018 I Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, today 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.
“We are very pleased to announce the CTA submission and look forward to starting patient recruitment as fast as possible after regulatory approval. Based on a strong preclinical data package demonstrating that ATOR-1015 localizes to the tumor and selectively activates the immune system in the tumor area, we have high expectations of this first-in-class drug candidate,” 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.
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.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes four lead clinical and preclinical drug candidates (ADC-1013, ATOR-1015, ATOR-1017 and ALG.APV-527). ADC-1013 (JNJ-7107) is licensed to Janssen Biotech, Inc., part of J&J, for global development and commercialization. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 50 employees. For more information, please visit www.alligatorbioscience.com.
SOURCE: Alligator Bioscienc
Post Views: 15
LUND, Sweden I July 19, 2018 I Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, today 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.
“We are very pleased to announce the CTA submission and look forward to starting patient recruitment as fast as possible after regulatory approval. Based on a strong preclinical data package demonstrating that ATOR-1015 localizes to the tumor and selectively activates the immune system in the tumor area, we have high expectations of this first-in-class drug candidate,” 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.
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.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator’s growing pipeline includes four lead clinical and preclinical drug candidates (ADC-1013, ATOR-1015, ATOR-1017 and ALG.APV-527). ADC-1013 (JNJ-7107) is licensed to Janssen Biotech, Inc., part of J&J, for global development and commercialization. Alligator’s shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 50 employees. For more information, please visit www.alligatorbioscience.com.
SOURCE: Alligator Bioscienc
Post Views: 15
