ADC Therapeutics has entered into an exclusive licence agreement with Mitsubishi Tanabe Pharma (MTPC) to develop and market Zynlonta (loncastuximab tesirine-lpyl) for the treatment of hematologic and solid tumours in Japan.
Zynlonta is an antibody drug conjugate (ADC) that binds to a CD19-expressing cell, making enzymes to release a pyrrolobenzodiazepine (PBD) payload.
The payload binds to DNA minor groove with slight distortion, and stays undetected by the DNA repair mechanisms, leading to cell cycle arrest and tumour cell death.
Under the terms of the agreement, the Swiss biotech firm will receive an upfront payment of $30m and up to $205m in potential milestone payments.
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 be responsible for Zynlonta clinical studies in Japan, and will hold the right to participate in any global clinical studies of the product by sharing the costs.
Mitsubishi Tanabe Pharma Corporation chief executive officer Hiroaki Ueno said: “MTPC is delighted to collaborate with ADC Therapeutics, a leader in the field of antibody drug conjugates, to develop and commercialise Zynlonta in Japan.
“We will try to improve the quality of life of patients suffering from cancer with the use of ADC Therapeutics’ novel anti-CD19 ADC, Zynlonta.”
Zynlonta has been approved by the US Food and Drug Administration (FDA), to treat previously treated relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The US health agency has granted accelerated approval to Zynlonta, as the first and only CD19-targeted ADC as a single-agent treatment for DLBCL.
The European Medicines Agency (EMA) has validated a marketing authorisation application (MAA) for the drug, and has granted Orphan Drug designation in DLBCL.
Zynlonta is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
Overland ADCT BioPharma, a partnership between Overland Pharmaceuticals and ADC Therapeutics, is working to develop and market Zynlonta in greater China and Singapore.
The joint venture is conducting a Phase 2 study of the drug in r/r DLBCL in China, which would support the potential registration of Zynlonta in China.
ADC Therapeutics chief executive officer Chris Martin said: “This license agreement with MTPC, a leader in the Japanese pharmaceutical industry, expands our global footprint in an important geography, and furthers our goal to make ZYNLONTA available globally to patients.
“We are excited to bring together our expertise in ADCs with MTPC’s extensive experience in Japan where there is significant unmet need for a safe and effective therapy for patients with relapsed or refractory DLBCL.”
ADC Therapeutics is focused on advancing next-generation, targeted ADCs for patients with hematologic malignancies and solid tumours.
Based in Lausanne, Switzerland, the company has operations in London, the UK, and the San Francisco Bay Area and New Jersey in the US.
