ADC-1013: Clinical drug candidate
ADC-1013 is an agonistic – or stimulatory – antibody that targets CD40, a receptor in the dendritic cells of the immune system, which are the cells that detect enemies such as cancer cells. ADC-1013’s activation of CD40 enables dendritic cells to stimulate the immune response’s weapons more effectively – in this case, T cells – allowing the immune system to selectively attack the cancer. ADC-1013 has been optimized using Alligator’s unique FIND technology, with the aim of improving binding affinity. This makes it possible to achieve efficacy with very low doses. In preclinical experimental models, ADC-1013 has been shown to induce a potent tumor-targeted immune response and provide long-lasting tumor immunity. In addition, preclinical data have demonstrated how ADC-1013 can be used against multiple types of cancer.
To date, the clinical program has comprised two Phase I trials. The first trial was conducted by Alligator, and focused on intratumoral administration. The results showed that ADC-1013 is well-tolerated at clinically relevant doses. A second Phase I trial (ClinicalTrials: NCT02829099) is currently being run by Janssen and focuses on intravenous dose escalation. The main purpose of the ongoing Phase I trial is to identify a safe, tolerable and biologically effective dose for ADC-1013 (JNJ-7107).
In January 2019, the results of the first clinical Phase I trial for ADC-1013 were published in the International Journal of Cancer (https://doi.org/10.1002/ijc). 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. The results from the ongoing second Phase I study were presented at ASCO 2019 Annual meeting held in Chicago on May 31- June 4. The results showed that side effects were generally mild and transient. Doses up to 1200 μg/kg i.v without premedication, and up to 2000 μg/kg with premedication have been shown to be safe and tolerable. Early signs of clinical activity in this study included a partial response (PR) in a patient with renal cell cancer and 10 patients with prolonged stable disease (SD) ≥6 months.
In August 2015, Alligator outlicensed the global development and commercialization rights of ADC-1013 to Janssen Biotech, Inc. 30 July 2019 Janssen decided to stop further development of the product and Alligator regains all rights for development and commercialization. Under the license agreement Alligator has received USD 46 million in upfront and milestone payments.