Type of information: Milestone
Compound: ADC-1013 (JNJ64457107)
Company: Janssen Biotech, a J&J company (USA - NJ) Alligator Bioscience (Sweden)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
- monoclonal antibody. ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulation of CD40 on dendritic cells initiates a process leading to a dramatic increase in T effector cells attacking the tumor.
- • On October 1, 2015, Alligator Bioscience announced that its agreement with Janssen Biotech, granting an exclusive worldwide license to Alligator’s clinical candidate ADC-1013 has been approved by the Federal Trade Commission under the Hart-Scott-Rodino act.
- • On August 12, 2015, Janssen Biotech announced an exclusive, worldwide license agreement with Alligator Bioscience AB for ADC-1013, an immuno-oncology agent currently in Phase 1 clinical studies. The agreement was facilitated by Johnson & Johnson Innovation, London. Under terms of the agreement, Janssen will attain rights to develop and commercialize ADC-1013, an agonistic fully human monoclonal antibody. ADC-1013 targets CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulating this receptor initiates a process leading to an increase in T cells attacking a tumor. Alligator Bioscience will complete the current Phase 1 dose escalation study and Janssen will be responsible for all subsequent development of ADC-1013, including research, development, manufacturing, regulatory and commercialization activities.
- Alligator Bioscience will receive an upfront payment plus additional milestone payments contingent upon reaching certain pre-determined development, regulatory and commercial milestones. In a separate transaction, Johnson & Johnson Innovation - JJDC, Inc. will subscribe for new shares of Alligator stock.
- • On January 3, 2018 – Alligator Bioscience announced that a development milestone payment of $ 6 million has been triggered under the partnership agreement for ADC-1013 (JNJ64457107) with Janssen Biotech. The milestone payment is for the partnership agreement to initiate a clinical combination study of ADC-1013 with one of Janssen’s proprietary PD-1 inhibitors. This is the first out of a number
of pre-defined milestones, related to the start of combination or phase II studies as part of the ADC-1013 clinical program, which all together have an aggregated potential value of $ 35 million.
- The licensing agreement with Janssen Biotech encompasses milestone payments up to a potential total value of $ 695 million. Alligator is also eligible to receive tiered royalties on
worldwide net sales upon successful launch and commercialization of ADC-1013.
- • On April 22, 2016, Alligator Bioscience announced an amendment of the protocol to expand the current Phase I Clinical Study to include a systemic administration arm. This entitles Alligator to a milestone payment of $ 5 million.
Separately Janssen and Alligator have also entered a research collaboration to broaden the pre-clinical data package of ADC-1013. Janssen will reimburse Alligator for 2.5 FTEs and running expenses under this agreement.