Alligator started dosing in the first clinical phase I dose escalation study (ClinicalTrials.gov: NCT02379741) in April 2015. The study was later expanded to include both intratumoral and intravenous dose escalation. An additional clinical phase I study (ClinicalTrials: NCT02829099) started dosing on 9 October 2016. The second study is sponsored by Janssen Research & Development, LLC and includes dose escalation with ADC-1013 (JNJ-64457107) administered intravenously. The Alligator sponsored trial continues to enroll patients for intratumoral dose escalation, while further enrollment for intravenous dose escalation will take part in the Janssen study.
Per Norlén CEO at Alligator says that “The start of the Janssen trial is very exciting. ADC-1013 now enters a phase of development where Janssen assumes responsibility for all future clinical studies.”
For further information, please contact:
Per Norlén, CEO, e-mail: email@example.com
Rein Piir, VP Investor Relations, e-mail: firstname.lastname@example.org
Office number: +46 46 2864280
ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. The functional activity of ADC-1013 has been investigated in human and murine in vitro models. In in vitro models, stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor. In addition, it is believed that once a tumor-specific memory is established, it may lead to long-term immunity to the cancer. Alligator granted Janssen Biotech, Inc., an exclusive, worldwide license to ADC-1013 in an agreement entered in August 2015.
Alligator Bioscience discovers and develops innovative antibody based immunotherapies for the treatment of cancer. Alligator Drug Discovery and Development span from early research phases up to proof of concept phase I/II clinical studies in cancer patients. In the discovery of novel antibody based drugs, Alligator uses its proprietary technology platforms FIND® and ALLIGATOR-GOLD®. FIND® (Fragment INduced Diversity) is an antibody optimization technology based on single-stranded DNA allowing generation of antibodies with significant clinical benefits. ALLIGATOR-GOLD® is a synthetic library containing several billion distinct fully human antibodies.