On October 12, 2016 Alligator reported dosing in the first clinical phase I dose escalation study (ClinicalTrials.gov: NCT02379741) in April 2015 (Press release, Alligator Bioscience, OCT 12, 2016, View Source [SID1234538691]). 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.
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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 protected]
Rein Piir, VP Investor Relations, e-mail: [email protected]
Office number: +46 46 2864280
About ADC-1013
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.