sapien biobank isber 08 may 2015_jain

Bio-banking & Clinical Diagnostics

Translational Science, Personalized Medicine

SAARUM SCIENCES

Phenotypic Drug Discovery

Vision and Mission of Biobank

12 May 2015 2

Vision:

To be a premier global biotech that employs human translational platforms for the discovery & development of novel diagnostics, biomarkers & drugs with better clinical outcomes

Mission:

• Build a systematic Biobank of ethically consented, high quality, geographically diverse human samples and associated medical data,

• Utilize these curated samples for developing novel biomarkers & diagnostics, modeling human disease, discovering drug targets & drugs with higher rates of clinical success

• Use tissues for R&D, NOT for regenerative medicine or transplantation

Sapien Biosciences

Bio-Bank

Exclusive*, network-wide access to tissues

Cash Funding

Alliance with Apollo Hospitals

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Incubation space & equipment

Serie

s B In

vesto

rs

• Bio-Banking• Personalized Med•Diagnostics R&D

• Phenotypic Screening•Disease Modeling• Target Disc & Validation

Ap

ollo

Ho

spit

als

Sapien and Saarum are sister companies; Saarum has access to Sapien’s samples for its R&D* Sapien is not exclusive to Apollo, it gets samples from other hospitals also

Sapien Biosciences

12-May-15 4

FY14 at Apollo hospitals

A typical weekday in the world of Apollo

The Apollo set-up – Asia’s largest hospital networkThe Apollo advantage

An abundant resource of diseased tissue samples and an honest will to use them for betterment of mankind- contributing to diagnostics and drug development - offering these new drugs / diagnostics for their patients

Footfalls Admissions Surgeries CT Scans MRIs300MRIs

600CT-Scans

20,000Footfall

1,500Admissions

800Major

Surgeries

1000Health checks

3-4 Organ

Transplants

350Dialysis

40Cardiac

surgeries

100,000+Pharmacy walk ins

• Cumulative experience of over 800 trials with 70% of these for FDA or EU registration

• Potential to undertake more than 200 trials at any given time

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Access to clinical network: Apollo Research and Innovation

Standardized SOPs

Clinical Trials Management System(CTMS)

17 networked sites

Resources

Highly Vigilant Ethics Committees

60 GCP trained CR Coordinators

200 GCP trained PIs

Reach

54 Apollo Hospitals

72 Apollo Clinics

Processes

Over 100 clinicians willing to participate

Current trials across therapeutic areas

Ethical Framework for Biobanking @ Sapien

• Sapien works within ICMR (Indian) and international guidelines

• Requirement for informed consent is waived for retrospective samples. These can be anonymized and banked with Ethics Committee approval (ICMR Guidelines, 2006)

• Sapien banks retrospective samples ‘left-over’ from procedures, with Hospital EC approval

• Approvals obtained from Apollo Ahmedabad, Bangalore, Chennai, Delhi, Kolkata and Hyderabad ECs to collect retrospective pathology blocks

• Sapien banks prospective samples where an additional sample is collected for a study with hospital EC approval and with Informed Consent from patients

• Informed consent language follows ICMR guidelines

• Sapien’s or Saarum’s IRB reviews use of such samples for specific projects

12 May 2015 6Sapien Biosciences

12-May-15 Sapien Biosciences 7

Type of Human Samples Banked at Sapien

• Retrospective, old left-over blocks dating back to ~15 yrs

• FFPE blocks – Tumors & adjacent non-tumor, other diseasesAlso non-diseased patient blocks

• Prospective samples - with informed consent

• Fresh tumor and adjacent non-tumor samples **• Hematol. tumors: Cell types (PBMCs, T/B cells, platelets etc.)• Blood, Plasma, Serum• Saliva, Urine, BAL, Pleural fluid, synovial fluid etc. • Non-diseased specimens

• Health Check-up left-over samples - with informed consent

• Serum / Blood / Urine - With rich associated data

~30,000 patients’ blocks & data currently at Sapien. Expect 500,000 samples in ~5 yrsfrom just the Apollo network

~ 700 patients’ fresh samples at Sapien. Can collect ~50,000 fresh samples in 5 years

** Matched blocks/fresh tissue/cells, plasma/DNA in many cases

Retrospective FFPE Block Retrieval

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Dec 2013 - Sample retrieval launched from Hyderabad site

~8000

October 2014

Chennai initiated

~15000

January 2015

Delhi initiated

~30000

May 2015

Kolkata initiated

December 2013

Hyderabad initiated

2200

Sapien Biosciences

Retrospective Formalin Fixed Blocks @ Sapien – Organ wise distribution

* Data from single location - Apollo Hyderabad for ~3 yrs. Sapien is systematically retrieving samples from across Apollo network over several years

Distribution of Diseases – Retrospective Formalin Fixed Blocks (For just 1 year at 1 site)

Cancers comprise approx. half of the retrospective formalin fixed blocks at Apollos- Cancer tissues span benign to metastatic



Prospective Samples @ Sapien

Accessibility across Apollos – Can source many sample types and diseases based on requirement

Specific protocol-based EC approvals obtained for projects

Fresh tissues @ Sapien - Currently banked / feasible to source Abdominal cavity Tonsil Parathyroid Malignant Lymph nodes Surgical resection of Adenoids

Bladder Glossectomy Parotid Laryngectomy Surgical resection of the spleen

Brain Thyroid Pancreas Uterus Surgical resection of Tonsils

Breast Testis Ovary Prostate Fibroids from uterus

Kidney Stomach Omentum Penis Spinal Tumors, CSF

Colon Spleen Oesophagus Normal Lymph nodes Liposuction

Buccal Mucosa Spinal Cord Lung Male normal breast reduction Vitreous gel from eye

Gluteal Region Rectum Liver Female normal Breast reduction Synovial fluid

Cervix Skin Non malignant hysterectomy sample Cord Blood

Sapien’s Database Captures Wealth of Information on Indian Diseases and Response to Treatment by Indian Patients


First implementation of NCI’s caTissue database in India (Krishagni partnership)

Any specific inclusion / exclusion criteria can be set as per need of project

Demographics

PathologyFamily History

Visits History

Recurrence follow ups

Treatment information

Diagnostic data

Disease severity /

status

Molecular classification

Recorded routinely with all samples

Obtained on a case-by-case basis for specific projects

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Example CVD-T2D-Obesity• Matched DNA, plasma, urine etc. left-over from Apollo health checks can be banked• Can be associated with the biochemical data from health check• Age-matched samples from diseased vs. non-diseased individuals can be compared• Longitudinal follow-up data can be collected• Can study outcomes along the lines of Framingham Risk Score

• The database can be mined in many ways: disease treatment outcomes, demographics, genetic correlation to response to drugs, identification of risk factors for diseases etc.• Contribute to Indian Registry?

• Approach can be extended to other disease-specific database of samples and EMRs• Oncology : Matched sets of fresh live & fresh frozen tissue, formalin fixed block, blood, BM, urine• Inflammation, Opthalmology, CNS• Maternal and Childhood diseases: CF, Autism, • Rare monogenic diseases - ORDI

Sapien Biosciences

Sapien’s EMR Database – Knowledge-base

BUILDING SUSTAINABILITY

Case Studies in Diagnostics and R&D Services

Sapien-Saarum

Services Provided by the Biobank Benefit Many Groups

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BIOBANK

Prognostics: Predicting Disease Occurrence Risk

Diagnostics:Precisely

diagnosing disease

Theranostics:Optimizing Drug

Treatment

Treatments: Pharma/Biotech:

Companion diagnostic

development Research Tools: Tissue Microarrays,

Indian Cell Line bank

Custom Biobanking:

Creating custom repository

Sapien- Saarum

Global Life Sciences Industry and Academia

Academiclabs andHospitals

Indian Patients

Using Sapien’s Depth in Breast Cancer to Validate Recurrence Markers

Breast cancer recurrence diagnostics can help

• in optimizing effective treatment and avoiding excessive chemo/ radio therapy associated with severe side effects (~50% ER/PR+ patients do not recur)

• prescribing new targeted drugs to make therapy more effective (~25% ER-/PR- cancers do recur)

• Sapien- Oncostem partnership for validation of IHC-based biomarker panel focused on aggressiveness of cancer to better predict the risk of recurrence in five years

• Collating samples from ~2000 retrospective patients diagnosed with Stage 1, 2 & 3A breast cancer along with

• Full associated pathology, medical treatment history, recurrence and 5 year outcomes data

Upon successful completion, Sapien realizes milestones and royalties, and commercializes the test across Apollo network and partner hospitals

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Growing Size and Depth of Sapien’s Breast Cancer Collection

Hyderabad, 164

Delhi, 364

Chennai, 330

CURRENT INVENTORY = 858+* 16

103

302

177

121

7448

17

Inventory based on cancer stage

0 1 2A 2B 3A 3B 3C 4

• Work in progress for ~400 more cases from Chennai, ~150 from Kolkata, ~200 each from Bangalore & Ahmedabad• Expect to reach ~2000 unique breast cancer patient FFPE samples and treatment outcomes data by 2016

Sapien Biosciences

WIP: Extensive Data Available for 858 Unique Patients

Br Ca Stages

Data set

0 1 2A 2B 3A 3B 3C 4

16 103 302 177 121 74 48 17

Demographics √ √ √ √ √ √ √ √

ER status 16 94 273 150 102 61 41 -

PR status 14 94 273 150 102 61 41 17

Her 2 status 11 71 189 95 70 36 14 17

Ki 67 2 23 37 24 17 8 - 5

CT/RT/HT 13/13/10

77/73/77 240/187/196

145/123/129

102/90/78 54/54/51 42/40/37 14/19/21

Recurrence* L=4; D=11 L=1; D=9 L=4; D=10 L=2; D=7 L=5; D=9 D=3

5 YR Fol-up 1 47 164 82 50 6 5 2

* Samples from original and recurrence surgery often available

Growing Inventory of Triple Negative Breast Cancers : High Unmet Need Area

1

6

6

2

21

Triple Negative Breast Cancer (from Hyderabad) Total = 18

1

2A

2B

3A

3B

3C

4

9

10

6

Triple Negative Breast Cancer (from Delhi) Total = 29

1

2A

2B

3A

Expect ~120 more TNBCs from these and other sites – very useful to analyse drug targets, prognostic markers, effective drugs

Sapien Biosciences

Colon Ca: Predicting Response to Topoisomerase Inhibitors

• Human DNA Topoisomerase I (topo I) inhibitors camptothecin and its analogues (CPTs), represent one of the most potent class of anti-cancer drugs• 3rd generation drugs in clinical trials

• Used extensively to treat colorectal, ovarian, pancreatic and small cell lung cancer, however 60-87% patients do not respond to these drugs.

• Hence, in partnership with a Boston company, Sapien is validating a biomarker in Indian colon cancer patients to stratify responders vs. non-responders.• Also performing cross-platform validation to Ventana in India

Sapien will commercialize the biomarker in India upon successful completion

2012 May 2015 Sapien Biosciences

21Saarum Sciences

R&D - Culturing Human Cancers for Annotated Panels

Objectives :

• Screen new chemical or biological entities for companies in actual disease samples

• Generate Indian cancer patient response data by combining in vitro assays with outcomes

• Systematically screen Indian cancers against ‘pill box’ to repurpose drugs

• Conduct gene profiling of Indian cancers

• Derive Indian cell lines a la ATCC

ADVANTAGE: Genetic diversity / disease state based variations mimic clinical heterogeneity

* Ongoing acquisition and culturing for more sample types

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Cancer Type Successfully cultured*

Hematological 5

Brain 11

Breast >40

Cervical 2

Colon 3

Endometrium 1

Lung 1

Oesophagus 1

Prostate 5

Renal 2Poster No : 2201820

• Cells being characterized for rate of proliferation, generation of stem cells, expressionof molecular & histological markers, response to drugs etc

Culturing Fresh Breast Cancer Tissues

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P0 Day 15 P1 Day 5 P2 Day 4

SB-Br-408

P1 Day 7 P2 Day 7 P3 Day 7

SB-Br-6045

Creating a Model of Epithelial Mesenchymal Transition

• Natural phenomenon occurring during early development. In cancer, EMT is involved in: • the initial steps of metastasis• Potentially involved in the formation of cancer stem cells

• Therapeutics targeting EMT will target the crucial step of metastasis and the formation of secondary sites of cancer.

• We have engineered a regulated model of human EMT* using normal human breast tissue that is being characterized for phenotypic assays

• The EMT model generated will be useful for• target discovery or validation, • ID & screening of new drugs/combinations • ID novel EMT/Metastasis biomarkers

* Applied for provisional Patent Poster No : 2201820Saarum Sciences

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myPLATELETTM – Enabling Tailored Anti-Platelet Therapy

• Theranostic product for Precision Medicine

• Proprietary combination of genetic and cell-based test to enable physicians to optimize drug and dose adjustments to personalize ANTI PLATELET THERAPY.

• Test validated & currently in use at Apollo and other hospitals

Sapien Biosciences

Scope & Scale of Sapien’s Biobank – 5 years from now


• ~0.5M patient samples and records capturing diversity of many Indian diseases, from Apollo and non-Apollo hospitals across the country

• Focused collections of disease-specific sample databases

• Annotated panels of individual tumour types, 500-5000 specimens each e.g., breast, H&N cancer

• Industry leader in India & contributing Member of international biobanking consortia, publications and conferences

• Strategic partnerships with proven leaders in genomics, proteomics, metabolomics

• High-end Mol & Cell Bio, Pathology, Biobank, IT, Bioinformatics cores to:

• Develop prognostics, diagnostics, theranostics to improve patient outcome and promote wellness

• Develop companion biomarkers, identify drug targets and help repurpose available drugs

• Launch 5-10 new diagnostic tests developed in-house and ~20 customized from partners

• NABL, CAP, Biobank accreditation

Acknowledgments

• Apollo management, and leadership across individual Apollo hospitals

• Diagnostic labs especially Pathology & Hematology

• Database, IT, Med Records departments

• AHERF – Incubation space and equipment for Sapien, Scientific advisors

• IICT – Indian Institiute of Chemical Technology – incubation space for Saarum

• Nishith Desai Associates – Law firm investing their expertise, experience and faith in us

• RSN Co – Chartered accountancy firm, investing their expertise, experience and faith in us

• EC members of Hospital committees, IRB members

12 May 2015 26Sapien-Saarum

www.sapienbio.com [email protected] [email protected]

Thank You!

http://www.saarum.com/

R&D Infrastructure available to Sapien-Saarum

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Flow cytometry

Cell sorting

Fluorescent microscopy

Laser scanning confocal

SNPs, SNP arrays

Sequencing

Bioinformatics including pathway/ systems biology

Biacore

HPLC

GCMS

LC-MALDI-TOF

X-Ray diffraction

CD

Karyotyping

FISH

ISH

ELISAs

In-house @ Sapien / Apollo or at strategic collaborators

Propose Establishing Core Facilities for Advanced Tech Areas: High Density Tissue Microarray

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Many Advantages of TMA:

Array of tissues in small cores, at high density, to conserve tissue samples and reagents

• Imprinted on 3 inch glass slide

• Highly efficient - minimal usage of sample

• High throughput – process 100s of samples at a time

• Preserves tissue architecture – clinically relevant

• Semi-quantitative

• High demand worldwide

• Flexible formats

• Can be Stage-wise: 1-4

• Can be different tumours

• Can be tumour vs. normal tissue

Sapien Biosciences

Human Samples and Data have Enabled the Development of Many Drugs & Paired Diagnostics

http://www.cuttingedgeinfo.com/2013/oncology-spotlight-companion-diagnostics-drive-patient-recruitment/

sapien biobank isber 08 may 2015_jain

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