1

Introduction to DeciBio

Immuno-Oncology Biomarker Analysis Platform (I/O BioMAP)

2018

DeciBio Consulting, LLC

725 Arizona Ave, Suite #202

Santa Monica, CA 90401

Phone: (310) 451-4510

Email: info@decibio.com

www.decibio.com

DeciBio Contacts:

Andrew Aijian; Aijian@decibio.com

2

The DeciBio Immuno-Oncology Biomarker Analysis Platform (I/O BioMAP) is an interactive database of

biomarkers being explored in I/O clinical trials; the BioMAP is used to track biomarker and clinical trial

activity, monitor the competitive landscape, and identify emerging I/O biomarker strategies

I/O BioMAP Summary

• To date, we have captured biomarker data from >1,150 active

and ongoing immuno-oncology clinical trials

o I/O trials from clinicaltrials.gov are reviewed by

experienced immuno-oncology researchers and biomarker

data is extracted from each trial

o Biomarker data extracted from each trial includes:

▪ Biomarker

▪ Biomarker type (e.g., protein, DNA, cell)

▪ Analytical technology (e.g., ELISA, NGS)

▪ Purpose (e.g., predictive, monitoring)

▪ Sample type (e.g., tumor tissue, blood)

▪ Trial phase, start / completion dates, enrollment,

sponsors, therapies, etc.

• The biomarker data is imported into Tableau, which allows

granular interrogation and segmentation of biomarkers by type,

technology, sample type, purpose, sponsor, etc.

• The BioMAP enables pharma, diagnostic, and research tools

companies to identify emerging biomarkers of interest, assess

the I/O competitive landscape, and prioritize biomarker and

technology portfolio development

The database is updated

quarterly and currently

includes data from >1,150

clinical trials

3

The BioMAP is focused on active, biomarker-containing, cancer immunotherapy trials; biomarker data is

manually curated and reviewed to ensure accuracy and provide a deep level of granularity and detail

I/O Clinical Trial Biomarker Analysis Process

Identify I/O Trials1

• We used comprehensive search terms

to identify open or active I/O clinical trials

within clinicaltrials.gov which:*

o Include “biomarker analysis” as an

intervention

and / or

o Specify the use of some analytical

technique (e.g., IHC, next-generation

sequencing, ELISA) for biomarker

analysis in the trial description

• All immunotherapy modalities (e.g.,

checkpoints, cell therapies, oncolytic

viruses, BiTEs, other immuno-

modulators), including drugs with

secondary immune-modulatory

mechanisms, are included in the scope of

the BioMAP

Extract Information2

• We use a combination of automated

and manual data extraction

techniques to capture as much

information as possible from the trials

• Data collected from each trial includes:

o Trial start date and phase

o Target enrollment volume

o Primary and collaborating sponsors

o Types of biomarkers and purpose

of analysis

o Technologies used for biomarker

measurement

o Sample types used for biomarker

analysis

o Indication(s)

o Drugs and other interventions

• We also cross-reference trials with

conference abstracts and publications

Graph in Tableau™3

• The data is imported into Tableau to

allow visualization and segmentation

of the data by multiple parameters,

including:

o Trial Phase

o Trial start date

o Sponsors

o Biomarker and type

o Biomarker purpose

o Technology utilization

o Biomarker sample type

o Indication

Data extraction is conducted by

experienced scientists, researchers, and

consultants, often with advanced

degrees in the life sciences, to ensure

accurate data collection and

classification

Note: * Includes information only from I/O trials that contain sufficient biomarker information; database includes trials that were open, active, and enrolling as of 11/2016 – the BioMAP does not currently include data from trials that

were completed, withdrawn, or terminated before 11/2016; Clinicaltrials.gov listings may not contain comprehensive coverage of biomarker activity for a given trial; thus, some biomarker data may not be captured in this analysis

4

Within each trial, every mention of a biomarker, along with potential combinations of sample-type,

technology, and purpose, is captured as a distinct “biomarker mention”

Example of Clinical Trial Data Extraction

Purpose Technology Sample TypeBiomarkerKey:

Biomarker Biomarker Type Sample Type Technology Purpose Indication

PD-L1 Protein Tumor Tissue IHC Predicting therapy response Bladder Cancer

CD8 Protein Tumor Tissue IHC Predicting therapy response Bladder Cancer

Unspecified biomarkers Protein Tumor Tissue IHC Predicting therapy response Bladder Cancer

Gene expression signature Nucleic Acid Tumor Tissue RNA-sequencing Predicting therapy response Bladder Cancer

Neoantigen burden (TMB) Nucleic Acid Tumor Tissue WES Predicting therapy response Bladder Cancer

dMMR Nucleic Acid Tumor Tissue Microsatellite Analysis Predicting therapy response Bladder Cancer

PD-L1 Protein Peripheral blood cells Flow cytometry Predicting therapy response Bladder Cancer

cfDNA Nucleic Acid Urine Not specified Therapy response monitoring Bladder Cancer

When appropriate, we use our

domain knowledge to make

inferences to fill in gaps in the data

To facilitate data and trend

analysis, some data is categorized

into standardized buckets

In instances in which a particular piece of information is not

provided in the trial listing and can not be confidently discerned,

we capture that data point as “Not specified”

5

The BioMAP consists of a Tableau™ data visualization tool containing various “dashboards” that enable

dynamic and granular data analysis by biomarker, technology, sample type, sponsor, and indication

Tableau™ Data Visualization “Dashboards”

DeciBio can create custom dashboards or filter elements focusing on data of interest for clients

(e.g., internal trial watch lists, competitor summaries, trial sites / locations, etc.)

Biomarker landscape

summary

Trial segmentation matrix by

indication, biomarker, biomarker

type, technology, and sample type

Trial sponsor landscape

including sponsor-specific

biomarker, therapy data

Trend analysis by indication,

biomarker, biomarker type,

technology, and sample type

Therapy landscape including

therapy-specific biomarkers

and combination treatments

Biomarker and competitor

clinical trial timelineBiomarker deep dive

6

• The “Biomarker Landscape” dashboard is

useful for:

o Identifying top and emerging I/O

biomarkers (e.g., most-cited markers,

common late-stage markers), segmented

by biomarker type

o Identification of markers associated with a

particular sample type (e.g., blood-based

biomarkers for liquid biopsies)

o Digging deeper on clinical trials of interest,

by exploring external resources (e.g.,

conference abstracts, publications)

associated with particular trials

o Assessing the markers being explored

with various different technologies

o Identifying markers used for various

purposes (e.g., predicting response,

immune monitoring)

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Any of the graphical or table elements in

figures with a yellow-shaded header can be

used to filter the dashboard accordingly (e.g.,

click on a biomarker bubble in this graph to

filter the dashboard by that biomarker)

Use the “Biomarker” free-

text search box to search

for specific biomarkers

Click on any NCT number to filter the

dashboard for that particular trial and

to access links to the

clinicaltrials.gov page and/or external

references (blue-shaded rows)

Apply ranges to filter the contents of the

dashboard by the number of biomarkers

mentions or the number of trials in

which markers are mentioned

The “Biomarker Landscape” dashboard provides a detailed summary of the different types of I/O biomarkers

7

• The “Biomarker Trends” dashboard is useful for:

o Identifying the fastest-growing biomarkers /

biomarker categories, as well as trends

associated with:

▪ Analytical technology

▪ Sample type

▪ Testing purpose

▪ Indication

o Identifying which biomarkers have the most

“patient-power” behind them (i.e., the number

of patients enrolled in trials exploring each

marker)

o Evaluating which markers are gaining

momentum and worth consideration for

inclusion into assays, panels, or service

offerings

o Estimating the current addressable number of

patients for a particular I/O biomarker or

technology, as well as trends in the number of

addressable patients

The “Biomarker Trends” dashboard enables assessment of key trends by various biomarker parameters

Use the “Control Panel

on the left to filter content

on the dashboard by

each of the filter

parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Toggle the graph segmentation

(e.g., by biomarker, technology,

sample type)

Toggle this graph to show biomarker

distribution by the total number of

mentions, the number of trials in which

each marker is mentioned, or the

enrollment volume associated with

each marker (note: select a single

“biomarker purpose” filter in the control

panel to avoid double-counting when

considering enrollment volume data)

Click on any individual graph

element to show the biomarkers

that correspond to that segment in

the graph to the right

Toggle graph display to show

trial counts “By Year” or show the

“Running Total” since 2012

Hover the cursor over a graph

element to reveal pertinent

information for that data point (e.g.,

biomarker name and mention count /

trial count / enrollment vol)

8

• The “Biomarker Segmentation Matrix”

dashboard is useful for:

o Segmenting biomarker data at a very

granular level (e.g., phase 2-3 lung cancer

markers assessed by sequencing in

peripheral blood for predictive purposes)

o Evaluating novel / emerging predictive

markers for any given indication (e.g.,

biomarkers by indication x purpose)

o Identifying biomarkers associated with a

particular technology or methodology (e.g.,

liquid biopsy markers = peripheral blood

markers x technology)

o Assessing the various approaches being

used to explore any given biomarker

o Assessing which combinations of markers,

technologies, and sample types have the

most traction

The “Biomarker Segmentation Matrix” dashboard enables granular cross-segmentation of biomarker data

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Click here to toggle the matrix rows and columns to display any

combination of “sample type”, “technology”, “biomarker”, “biomarker

type”, “biomarker purpose”, or “indication”

Click here to toggle the matrix

display by either biomarker

mention counts, or trial counts

Enter a biomarker search term into

the free-text search box to filter the

entire dashboard accordingly

Click on any NCT number to filter the

dashboard for that particular trial, and to

access links to the clinicaltrials.gov page

and/or external references (blue-shaded rows)

The size of the bubble corresponds to the number

of biomarkers associated with the combination of

each of the parameters (e.g., number of markers

assessed by sequencing in peripheral blood); click

on any bubble to show the distribution of

biomarkers for those parameters in the table below

9

• The “Sponsor Data” dashboard is useful for:

o Identifying the key and emerging players

across I/O and/or for a particular biomarker

o Identifying and benchmarking against the

biomarker and immunotherapy activity for

a particular company / competitor of

interest

o Assessing which companies /

organizations are exploring particular

biomarkers

o Assessing which biomarkers / technologies

are highest priority for particular

companies (i.e., by segmenting by primary

sponsorship activity)

o Identifying potential biomarker / technology

partners

o Exploring the indications / applications

being pursued by academic / research

organizations that may have commercially-

relevant implications

The “Sponsor Data” dashboard shows biomarker and immunotherapy activity at the individual sponsor level

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Click on an organization name to show their

biomarker activity in this chart and the graphs below

Enter a biomarker search term into

the free-text search box to show

which sponsors are exploring a

particular marker

This graph shows the types and

counts of different immunotherapies

being explored by the sponsors;

hover the cursor over a bubble to

see additional details

Click the light blue and darker blue parts of the bars to

show the data from the trials for which that company is

a secondary or primary sponsor, respectively

10

• The “Therapy Information” dashboard is useful

for:

o Assessing the clinical activity (e.g., number

of trials, phase) and trends for I/O therapies

o Comparing the biomarker strategies /

focuses across different drugs and

companies

o Identifying I/O therapies / therapeutic

strategies being pursued by various

companies / organizations

o Evaluating different I/O combination

treatments (both I/O-I/O and I/O-non-I/O

combinations)

o Identifying potential companion diagnostic

markers (e.g., identification of inclusion

criteria and/or predictive biomarkers

associated with particular drugs)

▪ Assessing potential companion

diagnostic modalities (e.g.,

technologies, sample types)

The “Therapy Information” dashboard allows for segmentation of biomarker and trial data by immunotherapy

Click on any drug name to filter the blue, green, and red

graphs below to show the biomarkers, immunotherapies,

and non-immunotherapies associated with each drug

Click on any biomarker in this

graph to filter the graph above to

show the drugs for which that

biomarker is being explored

The green and red charts show the

immunotherapies and any non-

immunotherapies, respectively,

being explored alongside a

particular drug in clinical trials

Enter a sponsor name (e.g., “Novartis”)

into the free-text search to show the

immunotherapies and corresponding

biomarkers that sponsor is exploring

Enter a drug name or phrase here (e.g.,

“JCAR”) to segment the data accordingly

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

11

• The “Biomarker Distribution” dashboard is

useful for:

o Evaluating biomarker counts, mentions,

and enrollment volume by any

combination of:

▪ Phase

▪ Year

▪ Enrollment status

▪ Biomarker type

▪ Sample type

▪ Technology

▪ Biomarker purpose

▪ Sponsor

▪ Indication

▪ Drug intervention

o Diving deep on the biomarker strategies

of a particular company

o Identifying esoteric biomarkers

The “Biomarker Distribution” dashboard allows for detailed search and filtering of biomarkers

Use these filters to cut the data in the

table below by sponsor, indication,

biomarker, and/or therapy

Hover the cursor over a graph

element to reveal pertinent

information for that data point (e.g.,

biomarker name and mention count /

trial count / enrollment vol)

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Toggle the chart to show biomarker distributions by mention,

number of trials, or enrollment volume; for enrollment volume

distributions, select a specific “Biomarker Purpose” in the

control panel to avoid double-counting

Scroll to view all biomarkers;

click on a marker or NCT

number to filter accordingly

or link out to clinicaltrials.gov

12

• The “Trial Timeline” dashboard is useful

for:

o Identifying and tracking key upcoming

trial read-outs, overall and for specific

companies

o Assessing the timeline of progression

for particular biomarkers or

technologies

▪ Identifying near-, mid-, and

long-term biomarker and

technology trends

o Monitoring the progress of particular

trials of interest (e.g., changes in

enrollment or completion dates)

The “Trial Timeline” dashboard enables assessment of trial and biomarker activity over specific time-frames

Use the “Control Panel on

the left to filter content on

the dashboard by each of

the filter parameters shown

Multiple filters can be

applied within a

particular filter-set by

using “Ctrl + click”

Enter a sponsor name to show a timeline of the trials

for that sponsor within the selected time frame

Click here to select the time frame over

which you want to explore trials (based on

the expected completion or primary

completion date); you can select any

number of days, weeks, months, or years

Toggle the graph to show either primary

completion dates or trial completion dates

Enter a biomarker here, or click on a biomarker in

the table below to show the timeline of trials

exploring that particular marker

Click on a graph element to

show the trial timelines for any

particular indication

Click on a graph element to

show the trial timelines for

any particular technology

13

Access to the BioMAP is provided via Tableau Online, a cloud-based data visualization program; the

BioMAP can also be provided as a packaged workbook for viewing with the Desktop Tableau Reader

Dashboard Navigation

• A fully-functional demo of the BioMAP, containing

information from a limited data set of 175 trials, can

be accessed via the following link and login

credentials:

o Link: https://goo.gl/hSgnD8

o Username: demo@decibioresearch.com

o Password: decibiodemo1

• Email aijian@decibio.com if you would like a live

demo of the full-version of the BioMAP

14

Access to the I/O BioMAP is provided via Tableau Online; BioMAP subscription pricing varies depending

on the desired number of dashboards and the desired update frequency; custom dashboards and analysis

can be scoped separately

I/O BioMAP License Rates

Number of Dashboards

Annual Data Update Rate

1x(Once annually)

2x(Every-other quarter)

4x(Every quarter)

1

3

All

All licenses are global, allowing anyone within a

customer organization to access the BioMAP

Custom dashboards, using existing BioMAP data

and/or proprietary data can be developed; pricing

varies based on scope

DeciBio is happy to explore ways to customize the BioMAP to best suit customer needs

The BioMAP can be often be offered at a discount

if bundled with a consulting engagement

Annual licenses range from $2,500 - $45,000

depending on number of dashboards, frequency of

data updates, and organization size; email

aijian@decibio.com for pricing information for your

organization