Swedish biotech firm Alligator Bioscience has regained the global rights for tumour-directed immunotherapy ADC-1013 (JNJ-64457107) from Janssen Biotech.
The compound is an agonistic human monoclonal antibody designed to target CD40, an immuno-stimulatory receptor found on the immune system’s dendritic cells.
Stimulation of CD40 on dendritic cells is intended to induce effector T-cells that attack the tumour.
ADC-1013 is currently in its Phase I development programme to treat a variety of metastatic cancers. One study has been completed and another Phase I trial has completed patient enrolment.
Previous Phase I data showed the compound to be safe and tolerated at clinically relevant dose levels, noted Alligator Bioscience.
In addition, ADC-1013 demonstrated early signs of clinical activity, including a partial response in a renal cell cancer patient and prolonged stable disease for around six months in ten subjects.
Alligator Bioscience CEO Per Norlén said: “Our ambition with ADC-1013 was to create a CD40 antibody that stimulates the immune system without causing adverse systemic side effects. 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.”
The company is planning Phase II combinations trials and also intends to seek other partners for continued development of ADC-1013.
Alligator Bioscience granted an exclusive, worldwide licence for the compound to Janssen Biotech in 2015. The decision to return the rights is said to be part of Janssen’s strategy to prioritise research programmes.
Under the original agreement, Alligator has been eligible for around $695m in pre-determined development, regulatory and commercial milestones.
In addition, the deal involved tiered royalties on future net sales of the compound globally.
To date, Alligator Bioscience received a $35m upfront payment in 2015, as well as a milestone payment of $11m. Janssen was responsible for funding the development programme over the past years.