MSD and Daiichi Sankyo Announce $22 Billion Global Collaboration to Co-Develop and Commercialize Three Novel DXd ADCs

▎WuXi

Edited by Kant Content Team

Daiichi Sankyo and MSD jointly announced today,The two parties have reached a global development and commercialization agreement for Daiichi Sankyo's three antibody-drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd)., will jointly develop and potentially commercialize these candidate ADC therapies on a global scale. Daiichi Sankyo will retain exclusive rights in Japan. Daiichi Sankyo will be fully responsible for product manufacturing and supply.

These three potential "first-in-class" ADCs are all in clinical development, either as monotherapy or in combination with other therapies, for the treatment of various solid tumors. Patritumab deruxtecan, targeting HER3, was granted Breakthrough Therapy Designation by the U.S. FDA in December 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations who experienced disease progression during or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. The Biologics License Application (BLA) for patritumab deruxtecan is planned to be submitted by the end of March 2024, based on the Phase 2 clinical trial named HERTHENA-Lung01. The trial results were recently presented at the IASLC 2023 World Conference on Lung Cancer.

Ifinatamab deruxtecan, targeting B7-H3, is currently being evaluated in a Phase 2 clinical trial named IDeate-01 for the treatment of patients with previously treated extensive-stage small cell lung cancer (SCLC).Recently, updated results of the subgroup analysis from the phase 1/2 trial of ifinatamab deruxtecan in treating SCLC were announced at the IASLC 2023 World Conference on Lung Cancer. Raludotatug deruxtecan, which targets CDH6, is currently undergoing its first-in-human phase 1 clinical trial, and updated results from the treatment of patients with advanced ovarian cancer will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress 2023.

These three ADCs are designed using Daiichi Sankyo's proprietary DXd ADC technology, consisting of monoclonal antibodies linked to multiple topoisomerase I inhibitor payloads through a cleavable linker based on a tetrapeptide.

Under the terms of the agreement, MSD will pay Daiichi Sankyo an upfront payment of $4 billion and an additional $1.5 billion over the next 24 months. Moreover, MSD may pay up to $16.5 billion in future commercial milestone payments, bringing the total potential value of the collaboration to $22 billion.