Benzinga | Oct 30, 2020 07:16AM EDT

Genmab, ADC Thearpeutics Report Execution Of Amended Deal For ADC To Continue Development, Commercialization Of Camidanlumab Tesirine For TAC Antibody Targeting

Genmab A/S (NASDAQ:GMAB) and ADC Therapeutics SA (NYSE:ADCT) today announced that they have executed an amended agreement for ADC Therapeutics to continue the development and commercialization of camidanlumab tesirine (Cami).

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The parties first entered into a collaboration and license agreement in June 2013 for the development of Cami, an antibody drug conjugate (ADC) which combines Genmab's HuMax(r)-TAC antibody targeting CD25 with ADC Therapeutics' highly potent pyrrolobenzodiazepine (PBD) warhead technology. Under the terms of the 2013 agreement, the parties were to determine the path forward for 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 Hodgkin lymphoma patients in this trial who had received a median of five prior lines of therapy.

Cami is currently being evaluated in a 100-patient pivotal Phase 2 clinical trial intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). The trial is more than 50 percent enrolled and ADC Therapeutics anticipates reporting interim results in the first half of 2021.

"We have a long-standing relationship with the ADC Therapeutics team and believe they are an ideal partner for the ongoing development and potential commercialization of Cami," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to the continued advancement of this CD25-targeted ADC."

"We are delighted to have reached an agreement with Genmab which will allow ADC Therapeutics to leverage the hematology-focused commercial organization we are building in the U.S. for our lead program loncastuximab tesirine (Lonca) in non-Hodgkin lymphoma," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "When we started collaborating with Genmab on the development of Cami in 2013, ADC Therapeutics was a startup. Since that time, our team has grown significantly to encompass all aspects of ADC research and development. The U.S. commercial organization, including a hematology sales force, that we are establishing will position us strongly for the commercialization of Cami, if approved."

Under the terms of the amended and restated license agreement, the parties have agreed to eliminate the defined divestment process which was agreed in 2013 and that envisaged, among other things, offering the opportunity for third parties to continue the development and commercialization of Cami. The parties have also agreed, among other things, that Genmab will convert its economic interest in Cami into a mid-to-high single-digit tiered royalty on net sales.