The new partnership focuses on the development and commercialization of ADC Therapeutic’s ZYNLONTA in Japan. Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $30 million and up to an additional $205 million in milestones if certain development and commercial events are achieved.
Based in Lausanne, ADC Therapeutics is a commercial-stage biotechnology company tackling cancer with its next-generation, targeted antibody-drug conjugates (ADCs). The company’s ZYNLONTA is a CD19-directed ADC. Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) 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 tumour cell death.
The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. In addition to the FDA approval, a Marketing Authorization Application (MAA) for ZYNLONTA has been validated by the European Medicines Agency (EMA) and is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Japanese pharma company Mitsubishi Tanabe Pharma Corporation (MTPC) has received exclusive rights to develop and commercialise ZYNLONTA (loncastuximab tesirine-lpyl) for all hematologic and solid tumor indications in Japan. Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $30 million and up to an additional $205 million in milestones if certain development and commercial events are achieved.
Additionally, the Swiss company will 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 ZYNLONTA 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.
“This license agreement with MTPC, expands our global footprint in an important geography, and furthers our goal to make ZYNLONTA available globally to patients,” said Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics. “We are excited to bring together our expertise in ADCs with MTPC’s extensive experience in Japan where there is a significant unmet need for a safe and effective therapy for patients with relapsed or refractory DLBCL.”
Progress on ZYNLONTA in Asian markets
Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA 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 ZYNLONTA in China.
(Press release/RAN)
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