Under the license agreement, Janssen secured rights to develop and commercialize ADC-1013, which is now the subject of a Phase I dose escalation study. Alligator Bioscience will complete that study, while Janssen will be responsible for all subsequent development of ADC-1013—including research, development, manufacturing, regulatory, and commercialization activities.
In a separate transaction, Johnson & Johnson Innovation-JJDC, J&J’s venture capital arm, will subscribe for new shares of Alligator stock.
ADC-1013 is an agonistic fully human monoclonal antibody that targets CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. The companies reason that stimulating that receptor begins a process that leads to an increase in T cells attacking a tumor.
According to Alligator Bioscience, ADC-1013 was shown to overcome immune suppression, resulting in a strong anti-tumor response and eradication of the tumors in several tumor models. Mice cured from a certain tumor by ADC-1013 were subsequently resistant to the same tumor type even if no treatment was administered: “This confirms that ADC-1013 is able to evoke a long-term immunological memory that protects from new metastases for several months after treatment,” the company states on its website.
Alligator Bioscience is recruiting patients for a first-in-humans Phase I clinical study of ADC-1013, the company posted in its most recent update June 15 on ClinicalTrials.gov. The study’s purpose is to determine whether ADC-1013 is safe and tolerable when administered as repeated injections directly into the tumor tissue in patients with advanced solid tumors.
“ADC-1013 is a great addition to our growing immuno-oncology portfolio, which includes a broad range of approaches in both solid tumors and hematologic malignancies,” Peter F. Lebowitz, M.D., Ph.D., global oncology head, Janssen Research & Development, said in a statement. “We were very impressed with the properties of this antibody and we are excited to continue the development that will ultimately deliver it to patients.”
Headquartered in Lund, Sweden, Alligator Bioscience is a privately held developer of antibody-based cancer immunotherapies. In addition to ADC-1013, Alligator’s pipeline includes the preclinical bispecific immuno-oncology candidate ADC-1015, being developed for intratumoral administration; and the research-phase bispecific immuno-oncology candidate ADC-1016, which combines systemic administration with pharmacological effects are localized to tumors through the fusion of a tumor targeting antibody with an immune activating antibody.
The closing of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Janssen said its license agreement with Alligator Bioscience was facilitated by the London regional hub or Innovation Center of Johnson & Johnson Innovation, whose science and business experts work to accelerate development of innovations by startups prior to clinical proof of concept.