Cellular Tracking for Therapy Impact Analysis
Make your cell therapy treatment safer and better

Founder & CEODr. Harry Su
harrysu@luminxbiotech.com
www.luminxbiotech.com

LuminX Biotech
Established in 2020, “LuminX Cell Tracking Enabling Platform” aims to advancetechnology innovations of the global biotech industry, targeting the unmet needs in celltherapy by measuring the Cells’ location, migration and biodistribution in-vivo.
Our goal is to assess the Safety, Efficacy and Effectiveness of cellular drugs

before human trials.
LuminX Biotech
Taiwan, Taipei◆ 2022 Best Bio Startup CEO – Top 10◆ 2022 Ministry of Economic Affairs – Breakthrough New Venture Award◆ 2022 Third place in the National Science and Technology Council Elevator Pitch◆ 2022 Hsinchu Science Park Medical Device Industry Entrepreneurial Environment Innovation Program◆ 2022 Economic Daily News Start-up Star winning team◆ 2022 Unicorn Pitches in Asian Healthcare - TOP 3◆ 2022 TAcc+ Batch#7 Demo Day International development prize◆ 2022 Taiwan Start-up World Cup-First Runner Up◆ 2021 National Innovation Award Start-up Enterprise Award-Keep Innovating◆ 2021 COMPUTEX d&i Awards-Startup Award◆ 2021 Taipei Industrial Development Incentive and Entrepreneurship Grant Program◆ 2020 iCAN x TTA Acceleration Program◆ 2020 17th National Innovation Award Start-up Enterprise Award
www.luminxbiotech.com◆ 2019 16th National Innovation Award Start-up Enterprise Award

2

Unmet Need of Cell Therapy

Where?

How?

How many?

Location?

Migration?

Biodistribution(Bio-D)?

Drug inspection registration review requirements

Industry trend

The result of autologous cell therapy is hard to replace
Changes in cell dynamics, migration, tissue distribution andpersistence!!

Need to be discussed in preclinical trials!!
Special control method technology linking
cell therapy preparation draft(2020.08.26)
www.luminxbiotech.com

2A New Solution to Enhance Fluorescence Stability< 2 mins, decays with time
➢ Traditional
Fluorescent dyeSignaldisappears

X Fluorescent signal decays easily, unsuitable for long-term tracking.
X Cellular toxicity.
X High background noise, unable to locate cell position & migration.

LuminX Cell GPS System➢ LuminX
Tracking Kits

www.luminxbiotech.com> 180 days, stays super stable

XTag,signals forever✓ Fluorescent signal very stable, suitable for long-term tracking.
✓ Non-Toxic, Non-Gene Toxic✓ Special surface modification, ready-to-use one-step cell labelling✓ Cell’s Bio-distribution (Bio-D), Pharmacokinetic (PK), and Pharmacodynamic (PD) Analysis

LuminX Tracking Kits

ProductStem Cell Therapy

LuminX Tracking Kits
◆ Stem Cell Tracking Kit (LTK10001)◆ iPSCs Tracking Kit (LTK10002)

Cancer/Tumor Research◆ Immune Cell Tracking Kit (LTK10003)◆ Cancer Cell Tracking Kit (LTK10004)

Immunotherapy

www.luminxbiotech.com

5LuminX Tracking Kits
➢ LTK10001 labelled ADSC

LuminX Tracking KitsADSCs labelled with LuminX
Tracking Kits and DAPI➢ LTK10002 labelled iPSCs

WGA + LysoTracker

LuminX Tracking Kits

Merage image➢ Live Cell Tracking

www.luminxbiotech.com

6

Operation Model

LuminX Cell GPS System
Step 1
Cell labelling

Step 2LuminX-labelled cells delivering

XTag
LuminX Tracking kits (LTK).
Light up cells !!!

Doing Treatment inDisease & Cancer Model

Step 4

Step 3

Tissues/organs collection and treatment.

Data analysis/reportwww.luminxbiotech.com

7Material Introduction
(a)

(e)

(d)

(c)

(b)

100-nm LuminX reagent
30-nm LuminX reagentLuminX
deoxyHb
oxyHb
metHb

100-nm LuminX reagent
30-nm LuminX reagent
Alexa Fluor 546

Excitation spectra

Emission spectra

Long-fluorescent lifetime

Non-photobleaching

non-photoblinking➢ Ex : 532 nm - 594 nm / Em : 650 nm – 800 nm➢ Long fluorescent lifetime (～20ns)➢ Non-photobleaching, non-photoblinking➢ Non-toxic, non-genotoxic➢ Fluorescence does not influenced by harsh condition➢ Does not compromise inherent cell properties➢ Quantification of cell number
www.luminxbiotech.com

PNAS ,2007 ,104 ,727–732
J. Phys. Chem. A, 2007, 111 , 9379-9386
Nat. Nanotechnol. 2008, 3, 284–288

N V
8

Special Biocompatibility
Proliferation assay

Cell viability assay

MSCspcMSCs
pcMSCs-FND
LuminX-MSCs

12000

3000

2000

Splenocyte proliferation (%)

4000

Cell number

8000

4000
1000

00

cell only

1050

100200150

Day 1

FND concentration (ug/ml)

Day 4

Day 5

Day 6vv

40

Counts30

20LuminX-reagent

60
40

LuminX-reagent
20

Control

1/5

1/10

1/20

1/40

1/80

pcMSCs / Splenocyte

Cell Sorting analysis

Flow cytometry assay

Exocytosis assays

Control
Control
MSCspcMSCs
FND-pcMSCs
LuminX-MSCs

800Day 7

Control
Day 0Day 2Day 6Day 15v(ug)of LuminX-reagent
in cells
Amount(ug)of FNDs in cells
AmountDay 3

Time after seeding cells

Exocytosis assay
50

Day 2100v

Comet assay

Long-term trackingv
LuminX
CFSE
EdUv

SSC

Survival cell number

16000

Cell viability

5000

Immunomodulation assay

120

Control
LuminX-LSC

10001234567
Time (days)

8910

Fluorescence intensity

www.luminxbiotech.com

Far-RedSci. Rep. 2017,7, 45607
PNAS, 2007, 104 ,727–732

Nat. Nanotechnol. 2008,93, 284–288
Nat. Nanotechnol. 2013, 8, 682.

Exosome labelled with ExoTag

Only 5 minutes!
Centrifuge the mixtures at 20,000 g to form pellets.

(a) Membrane staining(c) Merge image(b) LuminX ExoTracker

CD910µm(a) Membrane staining

10µm10µm(b) LuminX ExoTracker(c) Merge image

CD63
10µm

10µm

10µm

CD81
www.luminxbiotech.com

10DNA/RNA

Protein

Etraction/NTA analyze

Only 5 minutes!
Centrifuge the mixtures at20,000 g to form pellets.
www.luminxbiotech.com

Publications
LuminX-labelled MSCs in vivo mechanism, safety, Biodistribution, PK and PD
analysis in ischemia kidneys-injured model.
J Biomed Sci, 28, 28 (2021)(90 days)Long-term
detection of LuminX-labelled hASCs with an invivo chondrogenesis model.
Polymers, 11, 1391 (2019)

Quantitative tracking of LuminX-labelled human stem/progenitor cells in large

animal model (pig animal)

www.luminxbiotech.com....

Sci. Rep. 7, 45607 (2017)

This paper proof-of-concept for the long-term tracking LuminX-labelledcells in lung-Injured Model
Nat. Nanotechnol. 8, 682–689 (2013)

More than 100 publish papers (from 2005-2021)

12

Core Value

Save time

Save budgets

Save manpower

50% R&D time

30% off budgets

50% less manpower

Understanding of the systemic safety and biological fate of cells.
Help customers to estimate the outcome of cell therapy products, Shorten the R&D process.
Predict the clinical outcomes and improve the quality of patient’s life.

www.luminxbiotech.com

13

Value Proposition

LuminX Cell GPS System for Preclinical
Evaluation of Therapeutic Cells
DevelopmentResearch

BasicresearchPreclinicalstudies

ClinicaltrialMarketingauthorization

Post-marketing

On market

Preclinical Gold Standard

LuminX Biotech aims to become thefor all cell-therapy-products before they enter clinical trails.
www.luminxbiotech.com

14Competitor LandscapeCompetitor

Company A

Company B

TargetCell tracking and analysis for human
MSCs, T-cell and iPSCs solution

Live cell imaging for antibody staining

Live cell imaging

Solution

Cell tracking Kit + Analysis Platform

Dye + Imaging Machine

Bioluminescence + IVIS system

Advantage••••Cell tracking
Background-free image/detection
Safety analysis
Efficacy analysis••

Cell trackingDifferent kind of fluorescence••Cell tracking
Non-invasive imageClients•••

Research institutes
Life science companiesCROs•••

Research institutes
Life science companiesCROs•••

Research institutes
Life science companies
CROs

www.luminxbiotech.com

15Competitor LandscapeCompetitor

Company A

Company B

Solution

LuminX Tracking Kit + Analysis Platform

Dye + Imaging Machine

Bioluminescence + IVIS system

Toxicity issues

No

Low Cytotoxic

Low Cytotoxic
Partial Genotoxic

Photostability

Very stable, non-decay

Decay with time

Decay with timeLong termtracking> 90 days

< 7 days< 3hrsResistant to noise(Background-free)

YES!
High resolution to specific cellNoYes,
low resolution

Quantificationof cell number

YES!
Breakdown to tissue levelNo, qualitative only

Yes, but semi-quantitative,
signal decay with time

Bio-D analysis

YES!
Whole body targeted organ> 90 days

NoYes, but semi-quantitative,
signal decay with time

Safety Data for
FDA filing

YES!
PK/PD/Potency data analysis

Qualitative
Description Only

Qualitative
Description Only

www.luminxbiotech.com

16

LuminX Vision

Cellular Tracking for Therapy Impact Analysis『 Mastering preclinical trials leads the way to master clinicalevaluations, and master the key for cell-based therapeutics! 』
by Dr. Harry Su