Genmab, an international biotechnology company headquartered in Copenhagen, Denmark, and Seattle Genetics, confirmed that Seattle Genetics has exercised its option to co-develop tisotumab vedotin. The companies originally entered into a commercial license and collaboration agreement in October 2011 under which Seattle Genetics had the right to exercise a co-development option for tisotumab vedotin at the end of Phase I clinical development.

Tisotumab vedotin is an  antibody-drug conjugate (ADC) composed of a human antibody that targets or binds to tissue factor or TF and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE).  Tissue Factor is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is in Phase I/II clinical studies for the treatment of recurrent cervical cancer and has additional potential for the treatment of other solid tumors.[1]


“Together … we’re looking forward to advancing tisotumab vedotin for the treatment of solid tumors.”


Going forward, Genmab and Seattle Genetics will co-develop and share all future costs and profits for tisotumab vedotin on a 50:50 basis.

MabPlex
 

“The combination of Genmab’s differentiated HuMax®-TF antibody and Seattle Genetics’ clinically-validated ADC technology has resulted in encouraging preliminary data for tisotumab vedotin in selected solid tumors. We very much look forward to working with Seattle Genetics to further develop this exciting first-in-class ADC product,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Promising data
“Our ADC partnership with Genmab has generated promising Phase I/II data for tisotumab vedotin in patients with recurrent cervical cancer. As Seattle Genetics opts into co-development of this clinical program, we add another potential product to our strong pipeline,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.

“Together with Genmab, we look forward to advancing tisotumab vedotin for the treatment of solid tumors,” Siegall added.

Manageable safety
Preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701) were announced in June 2017, demonstrating antitumor activity and manageable safety in recurrent cervical cancer patients. This announcement can be found here. Updated preliminary data from the Phase I/II study will be presented in an oral presentation during the upcoming at the annual meeting of the European Society for Medical Oncology (ESMO) to be held in Madrid, Spain, September 8-12, 2017.

Collaboration
In October 2011, Genmab and Seattle Genetics entered into a commercial license and collaboration agreement for ADCs. Under the agreement, Genmab was granted rights to utilize Seattle Genetics ADC technology with its HuMax®-TF antibody. In turn, Seattle Genetics was granted rights to exercise a co-development and co-commercialization option at the end of Phase I clinical development for tisotumab vedotin.

With today’s news Seattle Genetics exercises its option to co-develop tisotumab vedotin and the companies will share all future costs and profits for the product on a 50:50 basis.

As part of the agreement, Seattle Genetics will be responsible for commercialization activities in the US, Canada, and Mexico, while Genmab will be responsible for commercialization activities in all other territories around the world. Each party has the option to co-promote by employing up to 40% of the sales effort in the other party’s territories.