The phase I trial, which began in April 2015, is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five clinical sites in Sweden, Denmark and the UK (ClinicalTrials.gov: NCT02379741). The study is sponsored by Alligator and includes 24 patients and ten different tumor types.
The data will now be analyzed, focusing on safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response evaluation. The aim is to present the results during the fourth quarter of 2017 at a scientific meeting, followed by a publication in a scientific journal.
“The study has progressed very well and we look forward to evaluating the data,” said Per Norlén, CEO at Alligator Bioscience. “I would like to extend my warmest gratitude to all the patients and their families, as well as the investigators and clinical study staff who enabled this study to be successfully completed ahead of time.”
In August 2015, Alligator entered a collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which has the global development rights to ADC-1013.
In October 2016, Janssen Biotech Inc. started a second phase I clinical study (ClinicalTrials: NCT02829099). This study is an intravenous dose escalation study with ADC-1013 (JNJ-64457107).
The webcast can be accessed live on the link below and will be available on the company website 30 minutes after the broadcast.
Phone numbers for participants from:
UK: +44 2030089806
For further information, please contact:
Per Norlén, CEO
Telephone: + 46 46 286 42 80 (switchboard)
Rein Piir, VP Investor Relations
Telephone: +46 708 537292
Per-Olof Schrewelius, CFO
Telephone: +46 46 286 42 85
The information in the press release is such that Alligator Bioscience AB is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08.00 CET on 23 March, 2017.
About Alligator Bioscience
Alligator is a biotechnology company that develops innovative immune activating antibody drugs for tumor-directed immunotherapy. The Company has a pipeline of lead clinical and preclinical product candidates: ADC-1013, ATOR-1015 and ATOR-1016 as well as various research candidates. In August 2015, ADC-1013 was out-licensed to Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for further development and commercialization. The Company’s shares are listed on Nasdaq Stockholm under the ticker “ATORX”. The Company is headquartered in Lund, Sweden, and has approximately 40 employees. For more information, please visit http://www.alligatorbioscience.com.
ADC-1013 is a human, monospecific, agonistic, IgG1 antibody intended for immunotherapy of cancer. The drug candidate targets the co-stimulatory receptor CD40, which is expressed on, for example, antigen-presenting dendritic cells. The dendritic cells reside in blood vessels and various tissues where they discover and digest proteins from viruses, bacteria or cancer cells. Next, the digested proteins are presented to so-called T-cells which are activated and kill the infected cells or the cancer cells. ADC-1013 activates CD40 on dendritic cells, enabling them to activate T-cells more effectively and thereby increasing the immune system’s attack of the cancer.