Leading a new era of precision oncology

PRECISION ONCOLOGYFOR TARGETED THERAPIES

CONTRACT RESEARCHSERVICES

MOLECULAR PATHOLOGY DIAGNOSTIC SERVICES

RESEARCH & DEVELOPMENTPROGRAMMES

Oncologica provides precision oncology testing to address the growing demand for molecular profiling of cancer patients for targeted therapies and functions as a Contract Research Organisation to support biomarker and drug development programmes worldwide.

In addition, Oncologica runs its own in-house R&D programmes focusing on the development of novel diagnostic and therapeutic intervention strategies targeting the cell cycle machinery.

Oncologica is a new molecular profiling laboratory set up to address the growing demand for personalised medicine. Our scientists and clinicians utilise state-of-the-art molecular diagnostic platforms in the analysis of patients’ tumour samples to maximise treatment benefit and reduce healthcare costs.

“The linking of specific cancer genetic alterations to the new generation of molecular targeted therapies is driving a new era of personalised medicine.”

PRECISION ONCOLOGYFOR TARGETED THERAPIES Comprehensive analysis of major cancer driver genes

in one single workflow dramatically reducing the cost of molecular profiling and accelerating reporting times

Reduced number of tests that cancer patients require

NGS semiconductor platform uses low DNA/RNA input (10ng) from FFPE samples enabling detection of actionable variants in fine needle biopsies and core needle aspirates

Generates a comprehensive picture of actionable mutations providing the clinician with a detailed molecular blueprint for optimal therapy choices and improved patient outcomes

Prevent the unwarranted prescribing of expensive targeted therapies to patients unlikely to benefit from such treatments


22 Gene Test Ion Ampliseq Lung and Colon cancer panel

22 gene panel for coverage of over 500 mutations implicated in colorectal (CRC) and non small cell lung cancer (NSCLC)KRAS, EGFR, BRAF, PIK3CA, AKT1, ERBB2, PTEN, NRAS, STK11, MAP2K1, ALK, DDR2, CTNNB1, MET, TP53, SMAD4, FBXW7, FGFR3, NOTCH1, ERBB4, FGFR1, FGFR2.Panel includes FDA and NICE approved predictors of response to erlotinib (Tarceva), gefitinib (Iressa), cetuximab (Erbitux).

Custom panels Custom designed DNA and RNA panels also available on request

Contact us at [email protected]

Oncofocus was developed as part of the US NCI-MATCH (Molecular Analysis for Therapy Choice) program for precision oncology involving 2400 NCI-affiliated hospitals, >700,000 patients samples, 120 phase 3 and 215 early phase trials.

The Oncofocus test utilises state of the art semiconductor technology to rapidly sequence DNA/RNA extracted from routine FFPE surgical biopsy material. The assay is designed to detect thousands of genetic alterations including SNPs, indels, CNVs and fusions across 52 of the major cancer driver genes linked to solid tumours. The data generated by the Oncofocus test is analysed using Oncologica’s bioinformatics platforms linked to the world’s largest curated compendium of cancer genetic information, enabling genetic alterations/variants to be linked to over 280 targeted therapies. Targeted therapies include all classes: -FDA approved therapies, -national comprehensive cancer network (NCCN) guideline referenced therapies and -therapies entered into US, EU and Japanese phase I, II and III clinical trials.

ONCOLOGICA TEST MENU FOR PERSONALISED ONCOLOGY

Oncofocus TestThe world’s most comprehensive precision oncology test for targeted therapies

52to

Genes relevantto solid tumors

gene alterations

aligneddetection of thousands of

variants

targeted therapies andmany more

undergoing clinical trials

over 270

ALK, AR, BRAF, CCND1, CDK4, CDK6, EGFR, ERBB2, FGFR1, FGFR2 FGFR3, FGFR4, KIT, KRAS, MET, MYC, MYCN, PDGFRA, PIK3CA.

COPY NUMBER VARIANTS

ALK, RET, ROS1, NTRK1, NTRK2, NTRK3, FGFR1, FGFR2, FGFR3, MET, BRAF, RAF1, ERG, ETV1, ETV4, ETV5, ABL1, AKT3, AXL, CDK4, EGFR, ERBB2, PDGFRA, PPARG.

FUSION DRIVERS

AKT1, ALK, AR, ARAF, BRAF, CDK4, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR2, FGFR3, GNA11, GNAQ, HRAS, IDH1, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, ROS1, SMO, TERT.

HOTSPOT GENES:


TARGETED NGS FOR ALL SOLID TUMOUR TYPES

FGFR2 AMPLIFICATION

AXL FUSION

MET FUSION

TSC2 MUTATION

SMO MUTATION

AXL FUSION

Bladder

Breast

Colorectal

Endometrial

Oesophagus

Gastric

Mesothelioma Osteosarcoma

Ovarian Pancreatic

GIST

Glioblastoma

Head and Neck

Kidney

Liver

Testicular

Thyroid

Prostate

Skin

Small Cell Lung Cancer

Soft Tissue SarcomaNon Small Cell Lung Cancer

EGFR FUSION

AKL FUSION

PDGFRA MUTATION

CDK4 MUTATION

HRAS MUTATION

CRIZOTINIB + DASATINIB

IPILIMUMAB

VEMURAFENIB

IMATINIB MESYLATE

VORINOSTAT

CABOZANTINIB

CLR-457

JNJ-42756493

CETUXIMAB

DABRAFENIB

ERLOTINIB

NERATINIB

ABL1 ABERRATION

PTCH1 MUTATION

RET MUTATION

BRAF MUTATIONERBB2 AMPLIFICATION

EGFR MUTATION

AFATINIB

DABRAFENIB + TRAMETINIB

MGCD-265

JNJ-42756493

CERITINIB

RIBOCICLIB

NTRK3 MUTATION

CDK4 MUTATION

EGFR AMPLIFICATIONFGFR2 FUSION

PROSTATE

TUMOUR TYPE GENETIC VARIANTS

35 genes and hundreds of variants tested in this tumour type

TARGETED THERAPIES

Over 90 potential treatments in this tumour type

NTRK2 FUSION

MAP2K1 MUTATION

ALK FUSION

TARGETED TREATMENTSThe fully integrated Oncofocus Assay and linked Oncofocus Reporter Database provide unparalleled information regarding an individual’s tumour that can be exploited to optimise treatment selection using the new generation of molecular targeted agents.

IHC protein expression profiling

FISH/CISH/DDISH molecular probes

Companion Diagnostics

State-of-the-art molecular tissue analytics for cancer diagnosis, patient stratification and personalised medicine. These services are available globally to healthcare providers, biopharma and biotech industries.

MOLECULAR PATHOLOGY DIAGNOSTIC SERVICES

ONCOLOGY FISH - Amplification

HER2/CEP17MET/CEP7FGFR1/CEP8FGFR2/CEP10EGFR/CEP7ERCC1/19p13TOP2A/CEP17AR (Xq12)/CEPXCDNK2A (p16, 9p21)/9q12)FGFR3/4p11PTEN (10q23)/CEP10

LYMPHOMA FISH (Breakapart probes)

MYC t(8:14)BCL2 t(14:18)BCL6 t(3q27)CCND1 t(11:14)MALT1 t(11:18)IGH t(14q32)

LYMPHOMA FISH (Fusion probes)

MYC/IGH/CEP8 Dual-Fusion Triple Colour

MELANOMAMELANOMA FISHRREB1/CCND1/MYB/CEP6 Abbott Molecular/Vysis

CISH

KAPPALAMBDAEBERCMVHPV Low RiskHPV High Risk

BLADDER CANCER

UroVysion FISHCEP3/CEP7/CEP17/CDKN2A (p16/9p21) Abbott Molecular/Vysis

ONCOLOGY FISH (Translocation)

RET (10q11) BreakapartROS1 (6q22) BreakapartBRAF (7q34) BreakapartALK Breakapart

MOLECULAR PATHOLOGYDIAGNOSTIC SERVICES

FISH/CISH/DDISH

OVER 30 tests available

Molecular probes for gene amplification and rearrangements including breakapart translocations

34βE12 (CK HMW)3β-HSD

0-9

ACTHAE1/AE3 (PAN CK)AFPALK-1 (lung)ALK-1 (lymphoma)Alpha-1-anti-chymotrypsinAlpha-1-anti-trypsinAmyloid AAndrogen ReceptorAnnexinAP-G2ABCG2AIMP-3 (EEF1E1)Annexin A5AprataxinAromatase (CYP19, P-23)

A

bAPPbcl-2bcl-2 (E17)bcl-6BerEP4Beta cateninBLIMP-1BOB-1BRCA1BRD-1

B

CA19.9CA125CA-IXCalcitoninCalponinCalretininCAM 5.2CD1aCD2CD2APCD3CD4CD5CD7CD8CD10CD11cCD13CD14CD15CD16CD19CD20CD21CD22CD23CD25CD27CD28CD30CD31CD33CD34CD35CD38CD40CD43CD44v6

CD45 (LCA)CD45RACD43CD44v6CD45 (LCA)CD45RACD45ROCD52CD54CD56 (N-CAM)CD57 (HNK-1, LEU7)CD61CD68 (KP1)CD68 (PGM1)CD71CD79aCD99CD105CD117 (C-KIT)CD123CD138CD163CD235a (GLYCOPHORIN A)CDK4CDK6CDX2CEAChromogranin ACK5CK7CK8CK14CK17CK18CK19CK20C-METCMV

Collagen IVCOX-2CXCL-12CXCL-13Cyclin ACyclin D1Cyclin D2Cadherin 6CD9CD147CK 5/6CXCL12CXCR4

C

C

D2-40DBA44Desmin DOG-1DRG-1

D

E2F3E-CadherinEBV (LMP)EGFR (HER1)EMAERER BETAERCC-1ESA (EPCAM)E2F3ELAV-1EN2

E

Factor VIII (vWF)Factor XIIIaFascinFibrinogenFoxP1FoxP3FSH

F

GalectinGastrinGCDFP-15GCET-1gemininGFAPGlucagonGlut-1Glypican 3Granzyme BGrowth HormoneGlutamine synthetaseGSTP-1

G

H.PyloriHBcAgHBME-1HBsAgh-caldesmonHCGHemaglobinHER2 (cerb-B2)HIF-1aHMAHMB45HMFG2HPVHSA (HepPar1)HSVIHSVIIHemoglobin gammaHER2 (Conc)HIG-2HOXA10H3S10phHSVIIHemoglobin gammaHER2 (Conc)HIG-2HOXA10H3S10ph

H

IHC for protein expression profiling Immunohistochemistry test menu

OVER 200 tests available

Napsin ANestinNeurofilament (NFP)Neutrophil elastaseNSE

N

Oct-2OCT-3 / 4Osteopontin

O

p16P24p27p40p53 (D01)p53 (D07)p57p63Pancreatic PolypeptideParvovirusPAX-2PAX-5PAX-8PD1PDGFRaPerforinPGP9.5PKC thetaPLAPPLK1PMS2PRProlactinPSAPSAPPSMAPTENPTHPARP-1Phospho AKTPhospho MTORPhospho RbpIGF-1RPIK3IP-1PNMA2

P

S100Sarcomeric ActinSerotonin (5TH)SMASMMSomatostatinSOX11SurfactantSynaptophysinSerpina3Sox-5

S

TAL 1B5 (HLA-DR)TCR-Beta (Beta F1)TdtThrombomodulin (CD141)ThyroglobulinTIA-1ToxoplasmaTP (Treponema pallidum)TRAPTSHTTF-1TDP-1TOPO-1TYRO3

T

Uroplakin-III

U

VEGFVEGFR3VimentinVS38cVZVVEGF-CVEGF-D

V

WT1

W

ZAP70

Z

Racemase (AMACR. P504S)Racemase/p63 cocktailRCCRET40f (Glycophorin C)RAD51

R

ICOSIDH1IgAIgDIgGIgG4IgMInhibinInsulinIRTA-1I-CAM 1IGF-1RIL-6RIL-7IL-8

I

J chain

J

KappaKappa (plasma cells)Kappa (renal)KPL1KSHV (HHV8)

K

L1 (CD171, L1-CAM)LambdaLambda (plasma cells)Lambda (renal)LamininLangerinLHLP34LysozymeLIFLM02

L

M30 cytodeathMast cell tryptaseMCM2Melan AMesothelinMGMTMIB-1 (Ki67)mLH1MNF116mSH2mSH6MUC-1MUC-2MUC-5ACMUM-1MyeloperoxidaseMYO D1MyogeninMyoglobinMCP-1MMP-7MMP-9MMP-10MMP-14MRE11aMSR-1MUC-1MUC-2MUC-5ACMUM-1MyeloperoxidaseMYO D1MyogeninMyoglobinMCP-1MMP-7MMP-9MMP-10MMP-14MRE11aMSR-1

M


Veterinary pathology servicesMolecular biomarker analysis using IHC, ISH and sequencingfor primary and differential diagnosis applications.

Quantitative image analysisGeneration and validation of image processing algorithms for automated quantification of protein biomarkers and molecular probes.

Digital scanningFully integrated high throughput high resolution digital scanning of test slides for digital pathology solutions.

We use high throughput automated platforms allowing fast turnaround reporting times.

Anatomic pathologySpecimen embedding Section cutting Special stains TMA production

H&E Preparation of cell line blocks for positive/negative controls for IHC and ISH


Pathology analytics for theranostic programmes

Analysis of protein biomarkers for companion diagnostics

Proof of concept and proof of mechanism studies

Biomarker clinical trials

Extensive knowledge base in anatomical and molecular oncopathology, companion diagnostics and translational medicine to provide high quality and cost effective contract research services for development of cancer biomarkers and molecular targeted therapies.


We offer contract research services for pharmaceutical, biotech, academic institutions and healthcare providers.

Development of novel companion diagnostics and new therapeutic intervention approaches

New testing strategies for patient stratification, companion diagnostics and personalised medicine

Biomarker discovery, verification and validation Proof of concept and proof of mechanism studies

Establishing cancer detection systems for primary diagnosis, treatment response and post-treatment

tumour surveillance

Analysis of pre- and post-treatment biopsies for assessment of therapeutic response

Preparation of cell line blocks for antibody characterisation and controls for test kits

Pre-clinical studies, including tissue culture model systems, tumour progression model systems,

xenografts, transgenics, tumourigenicity assays

Integration of pathology analytics with drug development programmes Identification of new drug targets and target validation

Our portfolio of services include:


Clinical Biomarker Trials

Expert tumour pathological assessment by diagnostic pathologists, including tumour

verification, evaluation of tumour area, proliferative fraction, vascular invasion, stromal response, % tumour

necrosis, scoring of inflammatory infiltrates and assessment of tissue fixation

Analysis of protein biomarkers including cell proliferation, apoptosis, signal transduction, invasion,

metastasis, cell metabolism and new candidate biomarkers

Molecular tissue analytics including IHC, FISH/CISH, Next generation sequencing, Analysis of tumour DNA

content, Assessment of tumour growth kinetics

Preparation of high density tissue microarrays for high throughput tissue analytics

Evaluation of H&E and IHC staining

Comparative pathology analyses

Clinical validation of biomarkers on FDA approved panels of normal and diseased human tissues

Human/animal tissue evaluation for microdissection studies

Development and validation of image processing algorithms


Oncologica capitalises on its extensive knowledge base and expertise in anatomical and molecular oncopathology, companion diagnostics and translational medicine to

provide high quality and cost effective contract research services to support theranostic programmes at all stages of the development pipeline.

With a tailored approach to our clients, we provide molecular pathology analytics to support biomarker and drug development from discovery through preclinical studies to

clinical trials.

Companion diagnostics

Cell cycle directed therapies

In house R&D programmes focusing on development of novel diagnostic and therapeutic intervention strategies targeting the cell cycle machinery

RESEARCH & DEVELOPMENTPROGRAMMES Theranostic strategies are often directed against complex and redundant growth signalling

networks from surface ligands and receptors through transducers to downstream effector molecules.

However the redundancy of these networks can result in low efficacy of molecularly targeted drugs and constraints on the performance of cancer biomarkers directed at these pathways.

An alternative approach is to target the cell cycle machinery, which acts as a convergence point for information transduced through upstream signalling networks and therefore

represents an exceptionally attractive diagnostic and therapeutic target.

Cell cycle machinery

RESEARCH & DEVELOPMENTPROGRAMMES

ReferencesJ Pathol. 2014 Aug;233(4):344-56.EMBO J. 2010 Oct 6;29(19):3381-94.

Clin Cancer Res. 2009 Apr 1;15(7):2417-25.J Pathol. 2012 Jan;226(2):352-64.

Am J Pathol. 2010 Oct;177(4):2034-45

Signalling cascades

Transcription factors

Growth factor receptors

G1

S

G2

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Suite 15 -16, The Science Village, Chesterford Research Park, Chesterford, Cambridge, CB10 1XL

www.oncologica.com

TELEPHONE

MAIL

+44 1223 785327

[email protected]

Professor Gareth Williams and Dr Marco Loddo are Co-founders and Directors of Oncologica and have in-depth knowledge and expertise in diagnostic oncopathology, translational biology, biomarker discovery and drug development.

Kitty Williams is the Senior Commercial Manager and is responsible for providing advice and implementation on commercial and corporate matters

Philippa Jones is the Senior Operations Manager and directs the tissue based diagnostic services of the company.

Katherine Marquis is the Senior Biomedical Scientist who directs the precision oncology services for targeted therapies

Keeda-Marie Snelson is the Lead Clinical Scientist with extensive expertise in the analysis of cancer genetic variants of clinical prognostic and predictive significance.

Rebecca Cadman is the Business Development Manager and is responsible for exploring new market opportunities and providing comprehensive support for existing clients.

MANAGEMENT TEAM

Read more about our team by visitng www.oncologica.com/team

Suite 15-16, The Science Village, Chesterford Research Park, Chesterford, Cambridge, CB10 1XL

www.oncologica.com

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