Pharma Focus Asia

Personalis Enters into a Research Agreement with FLX Bio to Provide Comprehensive Tumor Immunogenomic Profiling for Clinical Study

Tuesday, May 21, 2019

Personalis, Inc., a leader in advanced genomics for cancer, today announced that it has entered into a research agreement with FLX Bio, Inc., a biopharmaceutical company developing orally-available, small molecule drugs targeting the immune drivers of cancer and inflammatory diseases. Under the terms of the agreement, FLX Bio will utilize Personalis’ universal cancer immunogenomics platform, ImmunoID NeXT™, to evaluate therapy-related changes in tumors of advanced cancer patients participating in a Phase 1/2 clinical trial evaluating FLX475, a CCR4 antagonist, as monotherapy or in combination with pembrolizumab.

“Using the ImmunoID NeXT™ Platform for our FLX475 studies will help confirm its mechanism of action and demonstrate that inhibiting the CCR4 receptor with FLX475 blocks the migration of regulatory T-cells (Treg) into tumors,” said Brian Wong, M.D., Ph.D., President and CEO of FLX Bio, Inc. “With this cutting edge platform, we may be able to show that FLX475, by blocking Treg migration, decreases immune suppression and stimulates an immune response against cancer cells in the tumor microenvironment.”

Via the deep interrogation and analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT™ consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor escape mechanisms (including HLA typing and somatic mutation detection), immune repertoire profiles, neoantigen load, tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and immune checkpoint gene expression.

With the ImmunoID NeXT™ Platform, FLX Bio will be able to compare pre- and post-treatment tumor biopsy samples, providing a comprehensive picture of treatment-related changes in tumors. In addition, FLX Bio will use the platform to assess levels of a variety of inflammation-related and immune cell type-related markers in its ongoing Phase 2 clinical studies of FLX475.

FLX Bio is now enrolling patients with multiple types of cancer in the Phase 1 portion of its open-label, dose-escalation and cohort expansion Phase 1/2 study. The study is being conducted at leading cancer centers across the United States, Australia and Asia. The study will evaluate the tolerability profile of FLX475 as a monotherapy and in combination with pembrolizumab. Additionally, using Personalis’ ImmunoID NeXT™ Platform as well as other biomarkers, the study will also assess changes in the tumor microenvironment of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

“We’re delighted to work with FLX Bio, innovators who share our vision that a more comprehensive approach to tumor immunogenomic profiling is necessary to enable the development of more efficacious, next-generation cancer therapies,” Personalis CEO, John West, said. “ImmunoID NeXT™ is ideal for applications such as this: maximizing the data generated from a single tumor sample with the goal of characterizing the complex interplay between the tumor cells and immune cells of the tumor microenvironment. Our companies share a common belief that the complexity and dynamic nature of the tumor-immune interactions demands that combinatorial biomarkers will likely be required to most effectively predict responders and non-responders to these therapies.”

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