On January 29, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported the publication of the results from a clinical phase I first-in-human study of the CD40 agonistic antibody ADC-1013 (JNJ-64457107) (Press release, Alligator Bioscience, JAN 29, 2019, View Source [SID1234538671]). The top line data from this study was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2017.
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The results show that the agonistic anti-CD40 antibody ADC-1013 is safe and tolerated at clinically relevant dose levels. Furthermore, the pharmacodynamic effects and the preclinical data support the further clinical development of ADC-1013 against cancer and demonstrate the potential of ADC-1013 as a combination therapy with PD-1 targeted therapies.
Title: First-in-human study with intratumoral administration of a CD40 agonistic antibody, ADC-1013, in advanced solid malignancies.
Journal: International Journal of Cancer, View Source
Authors: Sandra M. M. Irenaeus, Dorte Nielsen, Peter Ellmark, Jeffrey Yachnin, Adnan Deronic, Anneli Nilsson, Per Norlén, Niina Veitonmäki, Camilla S. Wennersten and Gustav J. Ullenhag.
A second phase I study assessing the safety and tolerability of intravenously administered ADC-1013 is ongoing with Janssen Biotech Inc. as a sponsor and is not part of the current publication.
For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 am CET on January 29, 2019.
About ADC-1013
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Preclinical data have shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T-cell activation enables the immune system to attack the cancer. In addition, since some cancer cells express CD40 on the surface, ADC-1013 may act also through a secondary mechanism of action killing cancer cells directly.
In August 2015, Alligator licensed global development rights for ADC-1013 (JNJ-64457107) to Janssen Biotech, Inc. Currently, Janssen Biotech, Inc. performs a phase I dose-escalation clinical study (ClinicalTrials: NCT02829099) with intravenous administration of ADC-1013.