Policy & Regulation
ADC Therapeutics Inks Exclusive License with Mitsubishi Tanabe Pharma Corp. to Develop and Commercialize Zylonta (loncastuximab tesirine-lpyl) in Japan
18 January 2022 - - Switzerland-based commercial-stage biotechnology company ADC Therapeutics SA (NYSE: ADCT) has entered an exclusive license agreement with Japan-based Mitsubishi Tanabe Pharma Corp. for the development and commercialization of Zylonta (loncastuximab tesirine-lpyl) for all hematologic and solid tumor indications in Japan, the company said.

Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of USD 30m and up to an additional USD 205m in milestones if certain development and commercial events are achieved.

ADC Therapeutics will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in Japan.

MTPC will conduct clinical studies of Zylonta in Japan and will have the right to participate in any global clinical studies of the product by bearing a portion of the costs of the study.

In April 2021, the US Food and Drug Administration granted accelerated approval to Zylonta as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

A Marketing Authorization Application for Zylonta has been validated by the European Medicines Agency and is under review by the EMA's Committee for Medicinal Products for Human Use.

Zylonta has also received Orphan Drug designation in Europe for DLBCL. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize Zylonta in greater China and Singapore.

Overland ADCT BioPharma is now conducting a pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China, which is intended to support the anticipated registration of Zylonta in China.

Zylonta is a CD19-directed antibody drug conjugate. Once bound to a CD19-expressing cell, Zylonta is internalized by the cell, where enzymes release a pyrrolobenzodiazepine payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms.

This ultimately results in cell cycle arrest and tumor cell death.

The US Food and Drug Administration has approved Zylonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma.