NanoString, Celgene to develop companion Dx for REVLIMID

SEATTLE—NanoString Technologies, Inc. and Celgene Corporation have struck a collaboration for the development of a companion diagnostic using Nanostring’s nCounter Analysis System to support the clinical validation of REVLIMID for the treatment of diffuse large B-cell lymphoma (DLBCL). Per the terms of the agreement, NanoString will be responsible for developing the diagnostic, seeking regulatory approval and commercializing it, and in return, is eligible for payments totaling up to $45 million. Of that sum, $5.75 million consists of an upfront payment, with $17 million for potential success-based developmental and regulatory milestones and the remainder for potential commercial payments.

The upfront payment and part of the success-based milestone payments are expected to cover NanoString’s clinical development costs for the test. NanoString stands to receive potential commercial payments assuming sales of the in-vitro diagnostic do not exceed certain pre-established minimum annual revenues in the first three years following regulatory approval.

“We are excited to work with Celgene to help improve the lives of patients. Similar to our development of the Prosigna Breast Cancer Prognostic Gene Signature Assay, which is based on the PAM50 gene signature, this new collaboration demonstrates the power of our business model to leverage biomarker discovery and advance the treatment paradigm, bringing the right therapy to the right patient at the right time,” Brad Gray, president and CEO of NanoString, commented in a statement. “In addition, this collaboration further validates the nCounter Analysis System as the platform of choice for development of IVDs based on multi-gene expression assays, as well as the quality of our clinical and regulatory capabilities.”

In January of this year, researchers with the Lymphoma/Leukemia Molecular Profiling Project published a paper in Blood detailing how the development and validation of a biomarker assay based on a 20-gene expression DLBCL subtype classifier utilizing the nCounter Analysis System. The paper discussed how the system could accurately and robustly determine subtypes of DLBCL from formalin-fixed, paraffin-embedded tissue samples with site-to-site reproducibility and rapid turnaround time. NanoString secured a license to the relevant intellectual property to allow for the collaboration.

The in-vitro diagnostic companion test will be used to screen patients being enrolled in a pivotal study of REVLIMID for the treatment of DLBCL. Should the study be completed successfully, NanoString will seek regulatory approval for the test in key global markets, and will retain the ability to independently develop and commercialize additional indications for the test.

“Biomarker-driven clinical trials are the future of clinical oncology,” Jean-Pierre Bizzari, executive vice president of Clinical Development at Celgene, said in a press release. “Our collaboration with NanoString exemplifies our commitment to be at the forefront of science. The nCounter platform is expected to enable reproducible sub-typing of patients in our pivotal REVLIMID DLBCL study and will form the basis for companion diagnostic development. We are excited to work with NanoString’s experienced team to aid us in the development of a targeted treatment for patients with DLBCL.”

The term DLBCL refers to a heterogeneous group of cancers classified together based on morphology, immunophenotype, genetic alterations and clinical behavior, and represents the most common type of non-Hodgkin lymphoma. The National Cancer Institute estimates that DLBCL will comprise approximately 37 percent of the 70,000 new cases of non-Hodgkin lymphoma expected this year.

SOURCE: NanoString Technologies, Inc. press release