As per the agreement, the companies will develop and market Zynlonta for all hematologic and solid tumour indications, outside of the US, Greater China, Singapore and Japan
ADC Therapeutics, Sobi collaborate on Zynlonta. (Credit: Belova59 from Pixabay)
Swiss biotechnology firm ADC Therapeutics and Swedish Orphan Biovitrum (Sobi) have signed an exclusive license agreement for Zynlonta (loncastuximab tesirine).
As per the agreement, the companies will develop and market Zynlonta for all hematologic and solid tumour indications, outside of the US, Greater China, Singapore and Japan.
ADC Therapeutics is eligible to receive an upfront payment of $55m and $50m upon receiving European Commission (EC) approval of Zynlonta to treat diffuse large B-cell lymphoma (DLBCL).
The company is expected to receive around $330m in additional regulatory and sales milestones, along with royalties based on net sales of Zynlonta in Sobi’s territories.
Sobi will partly share costs for select global clinical trials of Zynlonta.
Both companies aim to commercialise Zynlonta, after obtaining a regulatory decision, in the first quarter of 2023.
Sobi chief executive officer Guido Oelkers said: “ADC Therapeutics has an innovative and validated technology platform and is a leader in the evolving field of antibody-drug conjugates.
“We are delighted about this collaboration to bring loncastuximab tesirine to Europe and beyond to serve an unmet need in debilitating orphan diseases in haematology.”
Zynlonta is an antibody-drug conjugate (ADC) that binds to a CD19-expressing cell to enable cell cycle arrest and tumour cell death.
The drug has been granted orphan drug designation in Europe, for the treatment of diffuse large B-cell lymphoma (DLBCL).
In April last year, the US Food and Drug Administration (FDA) granted accelerated approval for Zynlonta to treat previously treated adult patients with relapsed or refractory DLBCL.
In October, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Zynlonta.
ADC Therapeutics has reached an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and marketing of Zynlonta in Japan.
Overland ADCT BioPharma, a joint venture between Overland and ADC Therapeutics, will develop and market Zynlonta in greater China and Singapore.
In a separate development, Overland ADCT BioPharma announced the dosing of the first patient in China, with Zynlonta plus rituximab compared to standard immunochemotherapy.
The dosing was part of the LOTIS-5 confirmatory Phase 3 trial in second-line or later, transplant-ineligible patients with diffuse large B-cell lymphoma (DLBCL).