We have advanced our project pipeline significantly during the second quarter. The immuno-oncology antibody ATOR-1017 moved into pre-clinical development, and in addition, Alligator increased its focus on the co-stimulatory receptor 4-1BB with a co-development partnership agreement with Aptevo Therapeutics Inc. on the bispecific antibody ALG.APV-527. Our pipeline is now stronger than ever with four candidates for tumor-directed immunotherapy in clinical and pre-clinical development.
Encouraging data on ADC-1013
The collaboration with our partner Janssen Biotech for ADC-1013 is advancing well. The Phase I study being conducted by Janssen is progressing rapidly towards dose-selection. A previous Phase I trial was successfully completed in March. We also presented data at the PEGS conference in Boston showing that ADC-1013 may act synergistically with other immunotherapies, notably PD-1 checkpoint blockade and cancer vaccines. To date, more than 50 patients have received ADC-1013 and we are very encouraged by the data we have seen so far.
Tumor-directed properties shown for ATOR-1015
During the second quarter new data were presented for ATOR-1015, our first-in-class bispecific dual immune-activator. The data confirms its remarkable potential for tumor-directed immune activation which may be confined to the tumor area, potentially reducing systemic toxicity. The data also demonstrated anti-tumor effects in multiple tumor models, as well as strong signals on stability and manufacturing yield. We believe that the ability to localize CTLA-4 dependent immune activation to the tumor area will be critical for combination regimens with PD-1, which are currently limited by severe toxicity. ATOR-1015 is now moving into late pre-clinical phase, and the first toxicology studies have been successfully initiated.
Strongly positioned within the 4-1BB field
We also made significant progress in Q2 on 4-1BB (CD137), the co-stimulatory receptor which is the target of both ATOR-1017 and ALG.APV-527. The receptor 4-1BB is known to play an important role in enhancing the immune response to fight cancer. In June, ATOR-1017 became our third immuno-oncology asset to start CMC and enter pre-clinical development. This demonstrates the strength and breadth of our pipeline, and positions Alligator very strongly within the 4-1BB biology area.
ALG.APV-527 co-development agreement in place
We are very enthusiastic about our new partnership with the US-based biotech company Aptevo (July 2017). This collaboration brings together the strengths of both companies and is progressing rapidly. The process for manufacturing of clinical material, a very important milestone in drug development of therapeutic antibodies has recently been initiated (August 2017), and triggers the countdown to clinical entry.
Expanded collaboration with Stanford
The expansion of our immuno-oncology collaboration with Stanford University and Prof Dean Felsher to support our biomarker strategy is also very exciting. This will help accelerate the development of our pipeline projects and strengthen the biomarker discovery program significantly.
Honored to receive a donation for research
This has been another quarter of strong progress for Alligator. However, we never forget that the focus of all our efforts is to help patients who depend on us to find new approaches to the treatment of cancer. We were therefore honored to receive a donation for research into pancreatic cancer in memory of Jerker Löfgren, and we will continue to dedicate ourselves to finding solutions for those like Jerker whose lives have been affected by cancer.
CEO Alligator Bioscience AB (publ)
23 August 2017