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Biomarkers predictive of therapeutic responsiveness to chimeric antigen receptor therapy and uses thereof

a chimeric antigen receptor and biomarker technology, applied in the field of cancer biomarkers, can solve the problems of difficult to achieve clinical effectiveness, difficult to detect, and difficult to detect, and achieve the goal of clinical efficacy, so as to and reduce the risk of subject relapse

Pending Publication Date: 2021-06-10
NOVARTIS AG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

Provides a more reliable and objective basis for predicting patient response to CAR therapies, distinguishing between responders and non-responders, and guiding therapeutic decisions for improved treatment outcomes.

Problems solved by technology

In addition, traditional treatment options often have serious side effects.
Attempts have been made in cancer immunotherapy, however, several obstacles render the goal of clinical effectiveness difficult to achieve.
Although hundreds of so-called tumor antigens have been identified, these are generally derived from self and thus are poorly immunogenic.
Furthermore, tumors use several mechanisms to render themselves hostile to the initiation and propagation of immune attack.

Method used

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  • Biomarkers predictive of therapeutic responsiveness to chimeric antigen receptor therapy and uses thereof
  • Biomarkers predictive of therapeutic responsiveness to chimeric antigen receptor therapy and uses thereof
  • Biomarkers predictive of therapeutic responsiveness to chimeric antigen receptor therapy and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

ation of Novel Transcriptional Gene Signatures that Predict Subject Response to CD19 CAR-Expressing Cell Therapy in Chronic Lymphoid Leukemia (CLL) and Acute Lymphoblastic Leukemia (ALL) Using Whole Genome RNAseq and Unbiased Feature Selection

[0917]The present Example describes the identification of novel transcriptional gene signatures that predict patient response to CD19 CAR-expressing cell (e.g., T cell, NK cell) therapy (e.g., CTL019 therapy) in Chronic Lymphoid Leukemia (CLL) and Acute Lymphoblastic Leukemia (ALL), for use in accordance with the present invention.

[0918]Among other things, the present Example describes novel gene signatures based on mRNA expression levels of selected genes in apheresis and manufactured CD19 CAR-expressing cell (e.g., T cell, NK cell) product samples (e.g., CTL019) prior to re-infusion.

[0919]In particular, the present Example describes methods of unbiased feature selection to discover novel gene signatures that predict patient response to CD19 C...

example 2

ation of Novel Transcriptional Gene Signatures which Predict Subject Response to CD19 CAR-Expressing Cell Therapy in Chronic Lymphoid Leukemia (CLL) and Acute Lymphoblastic Leukemia (ALL) Using Gene Set Analysis and Differential Expression Analysis

[0926]The present Example describes the identification of novel transcriptional gene signatures that predict patient response to CD19 CAR-expressing cell (e.g., T cell, NK cell) therapy (e.g., CTL019) in CLL and ALL, for use in accordance with the present invention.

[0927]In particular, the present Example describes methods of Gene Set Analysis to discover novel gene signatures, for use in accordance with the present invention.

[0928]Among other things, the present Example describes novel gene signatures based on Gene Set Analysis, that are predictive of patent response to CD19 CAR-expressing cell (e.g., T cell, NK cell) therapy (e.g., CTL019). Gene set analysis was performed on gene sets described in Example 1, and with gene sets from three...

example 3

c Flow Cytometry-Based Assays

[0973]Prognostic flow cytometry-based assays are developed to screen subjects with cancer (e.g., patients with a hematological cancer such as ALL and CLL) for CAR-expressing cell (e.g., T cell, NK cell) therapy, e.g., CD19 CAR-expressing cell therapy as described herein such as, e.g., CTL019 therapy. In some embodiments, subjects are participating in clinical trials.

[0974]A sample (e.g., a blood sample) is isolated from a patient and a fluorescent flow cytometry-based assay is performed screening for one or more cell surface or secreted biomarkers described in Examples 1 and 2. An exemplary list of markers that are measured, e.g., by flow cytometry if cell surface-expressed, or by ELISA if secreted, and whose expression values predict patient response to CAR-expressing cell (e.g., T cell, NK cell) therapy, e.g., CD19 CAR-expressing cell therapy as described herein such as, e.g., CTL019 therapy includes, but is not limited to, genes listed in Table 8.

TABL...

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Abstract

Cancer biomarkers and methods of using them are disclosed.

Description

[0001]This application is a continuation of U.S. application Ser. No. 15 / 517,597, filed Apr. 7, 2017, now allowed, which is a U.S. national phase application under 35 U.S.C. § 371 of International Application No. PCT / US2015 / 054542, filed Oct. 7, 2015, which claims priority to U.S. Ser. No. 62 / 061,553 filed Oct. 8, 2014 and U.S. Ser. No. 62 / 144,682 filed Apr. 8, 2015, the contents of which are incorporated herein by reference in their entireties.SEQUENCE LISTING[0002]The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Oct. 7, 2015, is named N2067-7057WO_SL.txt and is 219,221 bytes in size.FIELD OF THE INVENTION[0003]The invention relates to cancer biomarkers and uses thereof.BACKGROUND OF THE INVENTION[0004]Many patients with B cell malignancies are incurable with standard therapy. In addition, traditional treatment options often have serious si...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C12Q1/6886G01N33/574C12N5/0783A61K39/00
CPCC12Q1/6886G01N33/57426C12N5/0636A61K39/0011C12Q2600/158G01N2800/52A61K2039/5158C12Q2600/118G01N33/574A61K39/4635A61K39/4631A61K2239/48A61K39/4613C12N5/0634A61K39/4636A61K39/464412A61K39/4611A61P35/00A61P35/02A61P43/00G01N2800/54G01N33/564C12N15/00C12Q1/6883A61K39/0008C12N2501/2307G01N2333/535
Inventor BEDOYA, FELIPEBITTER, HANSBROGDON, JENNIFERDORFMEIER, CORINGARG, ABHISHEKGLASS, DAVID JONATHANMANNICK, JOANMELENHORST, JAN J.MILONE, MICHAEL C.MURPHY, LEONORLANDO, ELENAWILCOX, NICHOLAS
Owner NOVARTIS AG
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