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

Cutting Edge Platform Enables the Detection of Changes in the Tumor
Microenvironment Following Treatment with FLX475

MENLO PARK, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/IOCombos360?src=hash" target="_blank"gt;#IOCombos360lt;/agt;–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.”

About Personalis, Inc.

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™
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
is GxP aligned as well as CLIA’88-certified and
CAP-accredited. For more information, please visit www.personalis.com
and follow Personalis on Twitter (@PersonalisInc).

About FLX Bio

FLX Bio is a clinical stage immunology-based biopharmaceutical
company focused on discovering, developing and commercializing oral
small molecule therapies for patients with significant unmet needs in
oncology and inflammatory diseases. Utilizing our proprietary discovery
platform, we develop highly selective small molecules that are designed
to modulate the fundamental immune responses underlying these diseases.
FLX has rapidly discovered and advanced two drug candidates each
uniquely targeting CCR4, including our lead oncology drug candidate,
FLX475, in now in clinical development and our lead inflammation drug
candidate, FLX193, expected to enter the clinic in atopic dermatitis in
the second half of 2019.


Contacts for FLX Bio, Inc.
Media Contact:
Angela Bitting
[email protected]

Investor Contact:
Sylvia Wheeler
[email protected]

Contact for Personalis, Inc.
Jennifer Havlek
[email protected]

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