CLN - Industry Playbook

GeneCentric, UNC Unite to Improve Prediction of Bladder Cancer Drug Response

Industry Playbook: March 2019

GeneCentric Therapeutics has teamed with the University of North Carolina at Chapel Hill to assess the response of bladder cancer patients to immunotherapeutic drugs based on their cancer subtypes. This collaboration will investigate the links between certain bladder cancer alterations, disease progression, and clinical response to checkpoint inhibitor therapy targeting programmed cell death-1 and programmed death-ligand 1 as well as other treatments. Ultimately, GeneCentric aims to use the study’s findings to augment the ability of the GeneCentric Bladder Cancer Subtype Profiler (BSP) to predict disease progression and drug response. Currently, GeneCentric’s BSP employs a 60-gene signature that comprises four bladder cancer subtypes and is based on proprietary data sets as well as approximately 2,700 genes from 408 bladder cancer patients in The Cancer Genome Atlas. The subtypes encompassed by the gene signature reveal differences in expression profiles of genes considered promising therapeutic targets in bladder cancer, such as FGFR3 and ERBB2. The BSP’s bladder cancer subtypes also show variability in immune profiles that could inform patient response to immunotherapy and are prognostic for stage 2 and 3 bladder cancer.

Johnson & Johnson, Veracyte Partner on NonInvasive Early Lung Cancer Tests

The Lung Cancer Initiative at Johnson & Johnson has joined forces with Veracyte to develop and commercialize novel diagnostic tests to detect lung cancer in its earliest stages. Under the terms of their agreement, the two companies will combine clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data, and Veracyte will contribute bronchial and nasal samples from its clinical trials. Veracyte will then use its RNA whole-transcriptome sequencing platform to analyze the combined cohort and provide comprehensive genomic content to Johnson & Johnson for therapeutic development purposes. Veracyte also expects the collaboration to accelerate two of its key lung cancer programs: the development of a noninvasive nasal swab test for early lung cancer detection; and the commercialization of the company’s Percepta Bronchial Genomic Classifier, a noninvasive test that detects genomic changes associated with lung cancer in the main airway of current and former smokers.

Southeastern Grocers, eTrueNorth to Open CLIA-Waved Labs in Retail Pharmacies

eTrueNorth, an integrated pharmacy-based clinical services network, has partnered with Southeastern Grocers to launch CLIA-waived laboratories at 253 retail pharmacies. The regional grocery and pharmacy chain, which serves Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, and South Carolina, will use the eTrueNorth ePOCT Suite, which provides software that simplifies administrative processes for organizations conducting CLIA-waived point-of-care testing. In addition, the Southeastern Grocers banners—BI-LO, Fresco y Más, Harveys Supermarket, and Winn-Dixie stores—will participate in eTrueNorth’s eLabNetwork Voucher Solution. This program enables employers to issue vouchers as part of work well-being initiatives so that employees can obtain wellness screenings at local pharmacies. “We are very pleased to begin offering fingerstick testing for common wellness screenings such as lipids and glucose at all eligible pharmacies,” said Gayle Shields, vice president of pharmacy services and grocery, nonfood at Southeastern Grocers. “Our goal is to provide customers with convenient and easily accessible programs and services that help them identify their risk of chronic diseases.”

Personal Genome Diagnostics, PathGroup to Develop Cancer Genomic Profiling Test

Personal Genome Diagnostics (PGDx) and PathGroup, a provider of anatomic, clinical, and molecular laboratory services, have teamed to co-develop the PGDx elio tissue complete assay. This collaboration will leverage PGDx’s scientific, development, and regulatory expertise along with PathGroup’s experience incorporating clinical next-generation sequencing into patient care pathways. Under the terms of the partnership, the companies will conduct studies to support and secure regulatory approval for the PGDx elio tissue complete assay. This panel is a 507-gene test for somatic alterations in cancer patients that detects single nucleotide variants, small insertion/deletions, amplifications, rearrangements, microsatellite instability, and tumor mutation burden. Once the assay is available, PathGroup intends to offer the test to the lab’s clients. “PathGroup is always seeking to expand and enhance the comprehensive genomic information we provide to oncologists and patients to better inform critical treatment decisions,” said Ben Davis, MD, CEO at PathGroup. “We believe this partnership will … significantly advance our offering for genomic oncology services.”

Guardant Health to Develop Co-Diagnostics for AstraZeneca’s Cancer Drugs

Guardant Health has entered an agreement to develop companion diagnostic tests on its liquid biopsy platform that will support AstraZeneca’s oncology portfolio. Under the terms of the partnership, Guardant Health will develop and pursue Food and Drug Administration (FDA) approval for a Guardant360-based companion diagnostic to help identify patients who may respond to Tagrisso (osimertinib), AstraZeneca’s third-generation EGFR inhibitor for advanced non-small cell lung cancer. Guardant Health will also develop a companion diagnostic that gives a plasma-based tumor mutational burden (TMB) score using the genomic profiling tool GuardantOMNI and that will predict response to AstraZeneca’s immune- and targeted oncology therapies. FDA has already granted breakthrough designation to the GuardantOMNI diagnostic device for its plasma-based TMB score, which means that the agency’s review of this test will be expedited. Additionally, the agreement between Guardant Health and AstraZeneca allows for the development of liquid biopsy companion diagnostics for AstraZeneca’s other clinical development programs.

Bristol-Myers Squibb, Boston Medical Center Search for Immunotherapy Response Markers

Bristol-Myers Squibb Company and Boston Medical Center are collaborating on a joint study to identify prognostic and potentially predictive sensitivity and resistance markers in cancer patients treated with standard-of-care checkpoint inhibitors. Specifically, the study will explore the role of tissue and circulating biomarkers as well as the microbiome in patients’ lack of response to immune-oncology therapies. The study will involve patients from Boston Medical Center, which is the largest provider of trauma and emergency services in New England and serves a diverse population, with 70% of the center’s patients coming from underserved communities. “These patients are sorely underrepresented in current research studies,” said Matthew Kulke, MD, chief of hematology/oncology at Boston Medical Center. “We look forward to partnering with Bristol-Myers Squibb on this study to identify and assess biomarkers across a diverse patient population, providing us with a deeper and more comprehensive understanding of immune-oncology resistance.”

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