Genmab A / S and ADC Therapeutics SA announced that they have entered into an amended agreement that will allow ADC Therapeutics to develop and commercialize Camidanlumab-Tesirin (Cami) will continue.

In June 2013, the parties entered into a collaborative and licensing agreement for the first time to develop Cami, an antibody-drug conjugate (AWK) that incorporates Genmab's HuMax  -TAC antibody that binds to CD25 with the highly effective pyrrolobenzodiazepine warhead technology (PBD technology) from ADC Therapeutics. Under the terms of the 2013 agreement, the parties should pave the way for the continued development and commercialization of Cami upon completion of a Phase 1a / b clinical trial. ADC Therapeutics previously announced that Cami achieved an overall response rate of 86.5%, including a complete response rate of 48.6%, in this study in patients with Hodgkin lymphoma who had received a median of five previous lines of therapy.

Cami is currently being investigated in a pivotal phase 2 clinical trial with 100 patients. The study is designed to support the filing of a BLA (Biologics License Application) application with the US FDA. The study is more than 50 percent proven, and ADC Therapeutics expects interim results in the first half of 2021.

" We have been working with ADC Therapeutics for a long time and believe that this team is an ideal partner for the ongoing development and potential commercialization of Cami," said Jan van de Winkel, Ph.D., and Chief Executive Officer at Genmab. " We look forward to the further development of the AWK targeting CD25."

“ We are pleased to have entered into an agreement with Genmab that will enable ADC Therapeutics to leverage the hematology-focused commercial organization we are building in the United States for our main program, Loncastuximab-Tesirine (Lonca) in non-Hodgkin lymphoma, "Said Chris Martin, Chief Executive Officer at ADC Therapeutics. "When we started working with Genmab to develop Cami in 2013, ADC Therapeutics was still a start-up. Since then, our team has grown significantly and is now dealing with all aspects of AWK research and development. With the US trade organization currently being set up, which also includes a hematology sales division, we will be ideally positioned for the commercialization of Cami - provided approval is granted. "

According to the terms of the amended and reformulated license agreement, the parties have agreed to discontinue the sale process decided in 2013. Among other things, this envisaged offering third parties the opportunity to continue the development and marketing of Cami. The parties have also agreed that Genmab will convert its economic interest in Cami into a tiered license fee in the mid to high single-digit range on net sales.

Camidanlumab-Tesirin (Cami, formerly ADCT-301) is an antibody-drug conjugate (AWK), which consists of a monoclonal antibody linked to CD25 (HuMax -TAC, licensed from Genmab A / S) binds and is conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. As soon as ADCT-301 docks with a CD25-expressing tumour cell, the AWK is introduced into the cell, where enzymes release the PBD-based agent and kill the cell. This applies to both CD25-expressing tumour cells and CD25-expressing Tregs. The intra-tumoral release of the PBD “warhead” can also lead to the “bystander killing” of neighbouring tumour cells. In addition, PBDs have been shown to induce immunogenic cell death. All of these properties of Cami can enhance immune-mediated anti-tumour activity.