We are very enthusiastic about the rapid progress of our 4-1BB (CD137) antibody ATOR-1017. This is our third immuno-oncology asset to enter pre-clinical development and it demonstrates the strength and breadth of our pipeline.
The CMC process for manufacturing of clinical material has been initiated in parallel with the pre-clinical studies. Initiation of manufacturing is a major investment both in terms of cost and time. The cost of producing clinical material is comparable to the cost of the first phase 1 clinical trial, and the full process takes about 2 years to complete. As a consequence, start of manufacturing is a very important milestone in drug development of therapeutic antibodies. ATOR-1017 has unique properties and is strongly positioned with potential to become a best in class 4-1BB antibody, and it is very encouraging to now have moved this compound to the next phase of development.
The target of ATOR-1017, 4-1BB, is a co-stimulatory receptor that is present on several immune cells. The compound was generated using Alligator´s human antibody library, ALLIGATOR-GOLD®, and further improved using our protein optimization platform. While there are 2 competing 4-1BB antibodies in early clinical development, we believe those to have suboptimal properties in terms of risk-benefit profile. We have used our extensive expertise in the TNF receptor superfamily field to develop a 4-1BB antibody with a unique target binding profile. In addition, the immune activating function of ATOR-1017 is dependent on cross-linking by so called Fcγ receptors expressed by immune cells. This property directs the immune activation to the tumor area where 4-1BB as well as Fcγ receptors are highly expressed. Tumor directed immunotherapy has the potential to add efficacy without adding dose limiting toxicity and this may allow more effective immuno-oncology combination therapies in the future.