ADC-1013: Clinical drug candidate out-licensed to Janssen Biotech, Inc.

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.

1. The dendritic cell presents the target molecule CD40 on its surface.
2. ADC-1013 binds to CD40 and starts signaling to activate the immune systems´ beneficial T cells.
3. The T-cells are activated to kill the tumor cells.

Project status

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. Janssen has completed the technology transfer associated with the manufacturing of clinical trial materials to Biogen Inc. – a US company with a large-scale manufacturing plant. 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.

In August 2015, Alligator outlicensed the global development and commercialization rights of ADC-1013 to Janssen Biotech, Inc. The license agreement comprises predefined milestone payments with a potential total value of about SEK 6 billion (USD 695 million). In January 2018, Alligator received a second milestone payment of SEK 50 million from Janssen, related to the decision to commence a combination study with ADC-1013 and one of Janssen’s own drug candidates. If the commercialization is successful, Alligator will also be entitled to incremental royalties based on global net sales.