US-based Adaptive Biotechnologies (Adaptive) has formed a translational collaboration with Japanese pharmaceutical company Takeda to use its clonoSEQ Assay in the clinical trials across the latter’s haematologic malignancy portfolio.
The collaboration will use Adaptive’s clonoSEQ Assay to assess minimal residual disease (MRD) to support the development and commercialisation of Takeda’s pipeline of treatments for patients with lymphoid malignancies.
The clonoSEQ Assay is claimed to be the first and only US Food and Drug Administration-approved in vitro diagnostic test for the assessment of MRD in lymphoid malignancies.
It can detect MRD in patients with multiple myeloma or B-cell acute lymphoblastic leukaemia using DNA from the patient’s bone marrow sample. It can also detect and monitor MRD in the blood or bone marrow of patients with chronic lymphocytic leukaemia.
The next-generation sequencing assay uses Adaptive’s immune medicine platform to detect and quantify specific DNA sequences found in malignant cells.
Nitin Sood, Adaptive Biotechnologies MRD chief commercial officer, said: “We are thrilled to enter into a broad translational collaboration with Takeda incorporating the use of our clonoSEQ Assay technology in clinical trials to support the clinical development of groundbreaking oncological therapies.”
To evaluate the depth and duration of response to Takeda’s investigational medicines in patients with lymphoid malignancies, the MRD status measured using the clonoSEQ Assay may be used as an endpoint in certain clinical studies.
The partnership will cover Takeda’s existing and future programmes.
Christine Ward, head of precision and translational medicine at Takeda’s oncology therapeutic area unit, said: “This collaboration with Adaptive allows us to further explore the clinical relevance of MRD as we progress our pipeline of investigational medicines.”