Date: 2015-03-16
Type of information: Refusal of an option
Compound: antibody-drug conjugate (ADC) product combining Genmab\'s HuMax-TAC antibody and ADC Therapeutics\' PBD-based warhead and linker technology
Company: Genmab (Denmark) ADC Therapeutics (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: refusal of an option
Action mechanism: ADCs combine a specific anticancer antibody or antibody fragment linked to a potent anticancer therapeutic. The aim is to combine better tumor penetration and killing properties with lower side effects for cancer patients. HuMax-TAC is a high-affinity fully human antibody targeting CD25, a therapeutic target with strong clinical validation. CD25 is expressed on a variety of hematological tumors and shows limited expression on normal tissues, which makes it a very attractive target for antibody-payload approaches. With HuMax-TAC-ADC, the partners aim to develop a first-in-class antibody-drug conjugate for the potential treatment of CD25-expressing lymphomas and leukemias. ADCs developed using ADC Therapeutics\' technology combine monoclonal antibodies specific to particular tumor targets with highly potent pyrrolobenzodiazepine (PBD) based warheads developed by ADC Therapeutic\'s partner Spirogen Limited.
Disease:
Details: * On June 17, 2013, Genmab and ADC Therapeutics have announced an agreement to develop a new antibody-drug conjugate (ADC) product combining Genmab\'s HuMax-TAC antibody and ADC Therapeutics\' PBD-based warhead and linker technology. The Companies have been conducting in vitro and in vivo studies since 2012 to investigate different warhead and linker combinations with HuMax-TAC, and now have the product ready for pre-IND preclinical development. The product will be developed for multiple cancer indications.
Genmab and ADC Therapeutics will each initially have an equal share in the product. In the first instance, ADC Therapeutics will lead and fund preclinical development. Prior to the submission of an application to conduct clinical studies in patients (IND filing), Genmab may elect to retain equal ownership of the product. Genmab will not incur any development costs prior to the IND filing decision and Genmab will maintain a minimum 25% ownership stake in the product as it moves into clinical development. No other financial terms were disclosed.
Financial terms:
Latest news: * On March 16, 2015, ADC Therapeutics announced that it has filed an Investigational New Drug application (IND) with the FDA as it moves its pipeline into clinical development. The IND is for a Phase I clinical trial for ADCT-301, a novel antibody drug conjugate targeting CD25. Simultaneously Genmab announced it has decided not to exercise the co-development right for HuMax-TAC-ADC under its agreement with ADC Therapeutics. Genmab will retain 25% of the rights to the product. Under the terms of the companies' agreement, Genmab had a 50% ownership stake with an option to maintain equal ownership of HuMax-TAC-ADC prior to the submission of an Investigational New Drug (IND) application and fund half of the development costs. Genmab has decided not to maintain its co-development right for HuMax-TAC-ADC, but will retain a 25% ownership stake in the product. ADC Therapeutics has indicated it intends to file an IND for HuMax-TAC-ADC in the first half of 2015.
