BMCC-2022-STU03

3D Digital Pathology with MetaLite Software and AI-enabled Analysis for Precision Diagnosis

BMCC

JelloX Biotech Inc. retrieves 3D digital pathology big data from clinical specimen including solid tumor tissues and regenerative organoids as a novel companion diagnostic solution. 3D image-inspired MetaLitesoftware and AI models support precision morphology characterization and cancer diagnosis. In collaboration with Intel, Roche, and Olympus, our innovative CPU-based operation system allows rapid, economic, and scalable implementation of JelloX digital pathology edge solution to personalized pathology and clinical trial sites.

未定中標題
BMCC Targeted indication

1. Lung cancer 3D panoramic pathology diagnosis
2. Breast cancer 3D panoramic pathology diagnosis
3. Digital pathology edge solution (in collaboration with Intel, Roche, and Olympus)

BMCC Status

1. Panoramic pathology platform for 3D PD-L1 profiling in lung cancer and breast cancer established and treatment outcome correlation in progress. 2. Companion 3D pathology analysis workflow for preclinical biologics and ADC drug development in progress. 3. AI-enabled models supporting tumor recognition, invasion recognition, 3D tumor proportion score and immunescore established and MetaLite will apply for FDA 510(k) clearance through SaMD pathway.

BMCC Key features
  • Patented tissue and image processing techniques to generate 3D morphology patterns and biomarker distribution from solid tumor, organoids, spheroids, cell blocks, and regenerative tissues
  • Novel discovery of spatial features of solid tumors from fresh biopsy and FFPE tissues compatible with current pathology workflow and Panoramic Pathology Platform integrating with canonical molecular diagnosis assays
  • MetaLite software supports multi-format pathology image process with standalone and plugin AI modeling running on CPU- based operation for personal pathology and precision medicine, and FDA 510(k) clearance is expected in 2022 Q4.
BMCC Market

PD-1/PD-L1 inhibitor market forecast is 47 Bn in 2022 with CAGR of 9.4% in upcoming 10 years.   Global companion diagnostic market will grow from 5.5 Bn in 2021 to 9.9 Bn in 2026 with a CAGR of 12.6%.  Among which oncology companion diagnostic size is projected to surpass 5 Bn.  Global digital pathology market is about 1 Bn in 2022 with a CAGR of 7.5% up to 2030. JelloX Biotech Inc. has been recognized as Market Ready Solution partner of Intel in 2022, and has established partnership with Roche, Olympus and biotech companies to integrate total solution from domestic market to international ecosystem.

MODE OF ACTION

EXPERIMENTAL RESULTS

Target Verification

3D digital pathology PD-L1 characterization with lung cancer FFPE tissues in retrospective study.

Target Validation

3D PD-L1 profiling in NSCLC for patient re-grouping based on spatial distribution of biomarker (3D tumor proportion score, 3D TPS).

Clinical Validation

Retrospective study on IO drug treatment outcome concordance with 3D TPS of PD-L1 (SP263) in NSCLC @ VGH-Taipei.

Description

Discovery of 15% test cases with 3D TPS variation >10% in clinical tissues.  3D PD-L1 positive (by JelloX) but 2D PD-L1 negative (by IHC) patients showing better concordance for IO treatment than conventional 2D diagnosis have been identified.

INTELLECTUAL PROPERTY

1. 6 Invention patents licensed from National Tsing Hua University
2. 12 Invention patents filed covering biological process, imaging process, and analysis system
3. 10 Invention patents being issued to JelloX Biotech Inc.

SELECTED PUBLICATIONS

1. J. Translational Medicine (2022) 20: 131 Computer-assisted three-dimensional quantitation of programmed death-ligand 1 in non-small cell lung cancer using tissue clearing technology
2. Drug Delivery (2020) 27, 542 Heparan sulfate targeting strategy for enhancing liposomal drug accumulation and facilitating deep distribution in tumors

BUSINESS OPPORTUNITY

1. Professional service and personal pathology for clinical research in hospitals and institutes
2. Open innovation for digital pathology edge solution for big tech and medical centers
3. Open innovation for companion diagnosis development with biotech and pharma

CONTACT

service@biip-dcc.org

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