21 May 2019 - - US-based Personalis, Inc., a specialist in advanced genomics for cancer, has entered into a research agreement with biopharmaceutical company FLX Bio, Inc., which is developing orally-available, small molecule drugs targeting the immune drivers of cancer and inflammatory diseases, the company said.

Under the terms of the agreement, FLX Bio will utilise 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.

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 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, microsatellite instability, 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.

Personalis, Inc. is a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response.

The company's NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample.

The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

FLX Bio is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercialising oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases.