SEATTLE—Celgene Corp. is tapping NanoString Technologies to create a companion diagnostic test for patient enrollment in a clinical trial of its drug Revlimid. NanoString will develop an in-vitro diagnostic (IVD) test for use on its nCounter Analysis System to screen patients for enrollment in Celgene’s Phase 3 trial of Revlimid for the treatment of diffuse large B-cell lymphoma (DLBCL). NanoString will be responsible for developing the IVD, seeking its regulatory approval and pursuing its commercialization. The company will receive $5.75 million in upfront cash from Celgene as part of the agreement and be eligible to receive total payments of up to $45 million.
NanoString CEO Brad Gray tells DDNews that the collaboration could be one of the largest of its kind. “In terms of its overall financial value, this may be one of the largest companion diagnostic collaborations ever,” he says. “We think it really creates a great precedent for us and other developers of diagnostics in terms of having the value we bring to the table recognized.”
Revlimid is already approved as a treatment for several conditions, including multiple myeloma and relapsed or refractory mantle cell lymphoma. Celgene plans to begin Phase 3 clinical trials in the next several months to test Revlimid for the treatment of DLBCL, the most common form of non-Hodgkin lymphoma (NHL). The National Cancer Institute predicts that DLBCL will represent approximately 37 percent of the 70,000 new cases of NHL this year.
The IVD NanoString develops will identify which of the several subtypes of DLBCL is found in patients. These various subtypes have been shown to have a significant effect on prognosis and treatment. Precisely identifying subtype is an important step toward developing new treatments that are effective in specific subsets of patients. “Biomarker-driven clinical trials are the future of clinical oncology,” says Jean-Pierre Bizzari, executive vice president of clinical development at Celgene. “Our collaboration with NanoString exemplifies our commitment to be at the forefront of science.”
The collaboration between Celgene and NanoString can be traced back to a paper published in the journal Blood last January by researchers associated with the Lymphoma/Leukemia Molecular Profiling Project. The researchers described their success at using NanoString’s nCounter Analysis System for a biomarker assay based on a 20-gene expression DLBCL subtype classifier. The paper concluded that the assay was effective at quickly identifying subtypes of DLBCL from tissue samples and well-suited for use for clinical trials and patient management. “The work of those researchers caught the attention of companies developing drugs for DLBCL, and one of those companies was Celgene,” says Gray. “Celgene contacted the researchers, who then contacted NanoString, and we then began a dialogue about how we could work together to apply these new ways of looking at DLBCL to the development of Revlimid.” NanoString has secured an intellectual property license for the classifier used by the researchers, which enabled the collaboration with Celgene.
NanoString’s alliance with Celgene represents a third area of growth for the company, according to CEO Gray. The first area, which has generated most of the company’s revenues, involves selling its diagnostic technology to researchers at academic centers and biopharma companies. The second involves selling FDA-approved diagnostic systems to clinical labs. NanoString marked a significant milestone in this second area last year when it received FDA clearance for its Prosigna Breast Cancer Prognostic Gene Signature Assay. The most recent area NanoString is now entering through its collaboration with Celgene is focused on drug development. “This third area involves partnering with biopharma companies to support drug development by creating custom diagnostics that can be used to select patients for the testing of their drugs,” says Gray. “We hope this will be the first milestone in what will become a new line of business for us.”
In addition to Celgene’s $5 million upfront cash payment to cover clinical development of the IVD, NanoString will be eligible for up to $17 million in payments based on reaching developmental and regulatory milestones. NanoString may also receive commercial payments in the event sales of its diagnostic do not exceed certain prespecified minimum annual revenues during the first three years following regulatory approval. The terms of the agreement also allow NanoString to independently develop and commercialize additional indications for the IVD.