Alligator Plans Phase II Trial of Immunotherapy Compound After Regaining Rights from Janssen
Alligator Bioscience, based in Lund, Sweden, regained exclusive, global rights to develop and commercialize ADC-1013, an immuno-oncology candidate, from Janssen Biotech, a Johnson & Johnson company.
ADC-1013 is a CD40 agonistic antibody in Phase I development for metastatic cancer. The product was originally licensed in a partnership deal in 2015, which has now been terminated in what is being called a strategic portfolio decision by Janssen.
“Our ambition with ADC-1013 was to create a CD40 antibody that stimulates the immune system without causing adverse systemic side effects,” stated Per Norlen, chief executive officer of Alligator. “The current data package suggests we have been successful. Observed side effects are generally mild, and the early signs of clinical benefit strengthen our confidence that, in ADC-1013, we have a CD40 immunotherapy with a highly competitive profile. Considering recent development in the CD40 field we are certainly optimistic about the future of this compound.”
CD40 is a receptor in the dendritic cells of the immune system. Activating CD40 causes dendritic cells to stimulate T-cells, which allows them to selectively attack cancer cells.
In one completed Phase I trial of the compound, ADC-1013 showed it was safe and tolerated at clinically relevant dosages. It also showed early indications of clinical activity, such as a partial response in a patient with renal cell cancer and prolonged stable disease in 10% of patients for longer than six months.
In June, Alligator and Janssen presented data at the American Society of Clinical Oncology (ASCO) Annual meeting on its ongoing Phase I trial, showing that side effects were generally mild and transient. The trial enrolled 95 patients and as of that presentation, a maximum tolerated dose hadn’t been reached.
The original deal with Janssen had the potential of milestone payments up to $695 million, with Alligator eligible for tiered royalties on any global net sales. Also, Janssen paid Alligator $35 million up front in 2015. In the years since, Janssen also paid $11 million in milestone payments.
On June 18, Alligator submitted a clinical trial authorization (CTA) application to launch a Phase I trial of its fully owned 4-1BB antibody ATOR-1017 for metastasizing cancer. The compound is an immunostimulatory IgG4 antibody that activates tumor-specific T-cells and NK cells via the costimulatory receptor 4-1BB. It will be a first-in-human, dose escalation trial in patients with advanced cancer and be conducted at three locations in Sweden. It expects to enroll up to 50 patients.
Of the returned rights from Janssen, Norlen stated, “We are very pleased with the progress our partnership with Janssen has made in the development of ADC-1013 but understand their need to prioritize research programs. Our priority now is to rapidly advance its development for the benefit of patients in need of new treatment options. We intend to initiate Phase II combinations studies and will make all necessary preparations for a swift start. In parallel we will advance partnering discussions to secure a future collaboration for the continued development of ADC-1013.”