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HTG, Sanofi Collaborating to Identify B-Cell Response Markers for Cancer Drug

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Originally published April 9.

By Turna Ray

A biomarker discovery collaboration between HTG Molecular Diagnostics and Sanofi US will use HTG's quantitative nucleic acid protection, or qNPA, technology to identify molecular targets in white blood cells associated with response to an unnamed cancer drug.

According to HTG and Sanofi, the aim of their joint effort is "to identify biomarkers that may lead to the development of a molecular companion diagnostic test to help identify patients most likely to respond to a novel Sanofi investigational agent."

The partners did not reveal the specific Sanofi drug to be used in the collaboration. However, using the qNPA platform, HTG will try to identify drug response markers in B-cells, which are a type of white blood cells that that make antibodies critical for immune system function and which play a role in a number of diseases, including acute lymphocytic leukemia.

Sanofi is investigating SAR3419, an inhibitor of the CD19 antigen, for the treatment of CD19-positive non-Hodgkin's lymphoma and other B-cell malignancies.

At the American Society of Clinical Oncology's annual meeting last year, data from a Phase I/II Sanofi-led study in patients with relapsed or refractory B-cell NHL expressing the CD19 antigen showed that SAR3419 was clinically active and the toxicities associated with the treatment were manageable.

Sanofi is also conducting Phase II investigations with SAR3419 in diffuse large B-cell lymphoma, the most common type of NHL; and B-cell acute lymphoblastic leukemia. ImmunoGen developed SAR3419 and licensed it to Sanofi as part of a collaboration between the firms.

HTG's qNPA technology measures mRNA and miRNA expression in formalin-fixed paraffin-embedded tumor samples, which the company claims allows certain advantages over other platforms.

In a 2008 publication in Blood, researchers from HTG, the University of Arizona, and elsewhere discussed data from a study in which they used HTG's qNPA assay to analyze FFPE tissue blocks from 36 genes previously associated with diffuse large B-cell lymphoma. "Gene-expression profiling studies in cancer have relied on snap-frozen tissues, which are often not obtained at diagnosis and are becoming decreasingly available in the current era of small biopsies," Rimsza et al. wrote in the article. In this study, the researchers used the qNPA assay to try to "overcome this obstacle."

The investigators analyzed more than 200 cases by qNPA, and reported that low levels of HLA-DRB and high levels of MYC are "independent indicators of survival, together distinguishing cases with the worst [diffuse large B-cell lymphoma] prognosis."

Overall, Rimsza et al. concluded that "prognostic genes can be meaningfully quantified using qNPA technology on FFPE tissues; previous [gene expression profiling] findings in [diffuse large B-cell lymphoma] are relevant with current treatments; and two genes, representing immune escape and proliferation, are the common features of the most aggressive [disease]."

HTG CEO TJ Johnson told PGx Reporter that qNPA technology doesn't require RNA extraction, labeling, or amplification. Furthermore, the test can accurately analyze small sample volumes, even when the samples are degraded, and can gauge very small expression level changes. According to HTG's website, the company has found that the qNPA technology "correlates well" with immunohistochemistry staining.

In addition to biomarker discovery solutions, the company also provides verification and validation services, which have been attractive for Sanofi and other pharmas, Johnson noted. "We can also effectively move the biomarker set from prototype to investigational-use only to IVD assay quality in rapid fashion — much quicker than other technologies," he added.


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