Personalis Announces Collaboration with MapKure to Use Personalis’ NeXT Platform™ for Clinical Trials and Companion Diagnostic Development
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.
As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure’s Phase 1a/1b dose escalation and expansion clinical trial. Additionally, MapKure will benefit from the breadth of the NeXT Platform, which enables broad tumor immunogenomic profiling of the tumor and consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample, which will help MapKure understand if other biomarkers are clinically relevant to BGB-3245.
“With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer treatment. Our NeXT Platform provides biotechnology companies, like MapKure, with comprehensive genomic information from the entire exome and transcriptome, and provides information that can support the identification of new, advanced biomarkers. Once these biomarkers have been selected by MapKure, we expect to develop them as a companion diagnostic for regulatory submission and approval. We look forward to working with MapKure to accelerate the development of their cancer therapy in the clinic by utilizing the results from our NeXT Platform,” said John West, CEO at Personalis.
Financial terms of the collaboration were not disclosed.
About Personalis, Inc.
Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. The Personalis 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. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc ).
MapKure is a clinical-stage company created in 2019 to develop precision medicines for patients with life-threatening diseases, with an initial focus on cancer. By focusing on genetically defined disease drivers, MapKure is positioned to advance the development of transformative medicines to patients whose unmet medical needs are largely unaddressed. MapKure is jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., and is currently developing BGB-3245 under an exclusive license from BeiGene in solid tumor patients harboring specific B-RAF driver mutations and fusions, as well as in patients who have developed resistance to first-generation B-RAF inhibitors.
All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform or the NeXT Dx Test, the expected benefits (including the potential for clinical trial use, companion diagnostic development and regulatory filings based on the company’s NeXT Platform or the NeXT Dx Test) of the company’s collaboration with MapKure, the company’s business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, the company’s registration statement on Form S-3 filed on December 30, 2020, and the company’s prospectus supplement filed on January 27, 2021, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.
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