Biodesix, Inc.

Krista Meyer

Heinrich Röder

Joanna Röder

Julia Grigorieva

Carlos Oliveira

Arni Steingrimsson

Maxim Tsypin

Senait Asmellash

Kevin Sayers

Caroline Maher

Jeffrey Weber

Ami Steingrimsson

A method is disclosed of predicting cancer patient response to immune checkpoint inhibitors, e.g., an antibody drug blocking ligand activation of programmed cell death 1 (PD-1) or CTLA4. The method includes obtaining mass spectrometry data from a blood-based sample of the patient, obtaining integrated intensity values in the mass spectrometry data of a multitude of pre-determined mass-spectral features; and operating on the mass spectral data with a programmed computer implementing a classifier. The classifier compares the integrated intensity values with feature values of a training set of class-labeled mass spectral data obtained from a multitude of melanoma patients with a classification algorithm and generates a class label for the sample. A class label 'early' or the equivalent predicts the patient is likely to obtain relatively less benefit from the antibody drug and the class label “late” or the equivalent indicates the patient is likely to obtain relatively greater benefit from the antibody drug.

Predictive test for patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1) checkpoint protein and classifier development methods

A method is disclosed for predicting in advance whether a melanoma patient is likely to benefit from high dose IL2 therapy in treatment of the cancer. The method makes use of mass spectrometry data obtained from a blood-based sample of the patient and a computer configured as a classifier and making use of a reference set of mass spectral data obtained from a development set of blood-based samples from other melanoma patients. A variety of classifiers for making this prediction are disclosed, including a classifier developed from a set of blood-based samples obtained from melanoma patients treated with high dose IL2 as well as melanoma patients treated with an anti-PD-1 immunotherapy drug. The classifiers developed from anti-PD-1 and IL2 patient sample cohorts can also be used in combination to guide treatment of a melanoma patient.

Predictive test for melanoma patient benefit from interleukin-2 (IL2) therapy

A method of generating a classifier includes a step of classifying each member of a development set of samples with a class label in a binary classification scheme with a first classifier; and generating a second classifier using a classifier development process with an input classifier development set being the members of the development set assigned one of the two class labels in the binary classification scheme by the first classifier. The second classifier stratifies the members of the set with an early label into two further sub-groups. We also describe identifying a plurality of different clinical sub-groups within the development set based on the clinical data and for each of the different clinical sub-groups, conducting a classifier generation process for each of the clinical sub-groups thereby generating clinical subgroup classifiers. We further describe an example of a hierarchical arrangement of such classifiers and their use in predicting, in advance of treatment, ovarian cancer patient outcomes on platinum-based chemotherapy.

Classifier generation methods and predictive test for ovarian cancer patient prognosis under platinum chemotherapy

A method is disclosed of predicting cancer patient response to immune checkpoint inhibitors, e.g., an antibody drug blocking ligand activation of programmed cell death 1 (PD-1) or CTLA4. The method includes obtaining mass spectrometry data from a blood-based sample of the patient, obtaining integrated intensity values in the mass spectrometry data of a multitude of pre-determined mass-spectral features; and operating on the mass spectral data with a programmed computer implementing a classifier. The classifier compares the integrated intensity values with feature values of a training set of class-labeled mass spectral data obtained from a multitude of melanoma patients with a classification algorithm and generates a class label for the sample. A class label 'early' or the equivalent predicts the patient is likely to obtain relatively less benefit from the antibody drug and the class label 'late' or the equivalent indicates the patient is likely to obtain relatively greater benefit from the antibody drug.

Predictive test for melanoma patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1) checkpoint protein and classifier development methods

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Steamboat Springs, CO, United States of America

Krista Meyer