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Certis Preclinical Slideshare
1.
CERTIS ONCOLOGYSOLUTIONS Oncologist-Directed Solutions for Cancer
Therapy& Drug Discovery Copyright © Certis OncologySolutions,2018 Privileged &Confidential Do not distribute without permission Pre-ClinicalResearchOfferings Jonathan Nakashima, PhD Director of Operations nakashima@certisoncology.com
2.
Certis OncologySolutions Operational focus
on orthotopic xenograft mouse modeling • Employs the Surgical Orthotopic Implantation (SOI)micro- surgical technique to establish Patient-DerivedOrthotopic Xenografts (PDOX) • Affiliated with physicians from UCLAand Memorial Sloan Kettering • Expanding our vivarium • Expanding our immortalized tumor bank to includepatient drug response information • Received more than 300 patient tumors and counting • CLIA certified for high-complexitytesting New Pre-clinicalCROFacilities • SanDiego-based facilityon aLife Sciencescampus • 7,000 sq. ft.facility • 2,000 sq. ft.ofLab space Copyright © Certis OncologySolutions,2018 2
3.
A Unique Model
forBuildingCohort Programs 1 2 Tumor samples arecollected from thepatient. 3 Various drug therapies are tested simultaneously in multiple mice, providing valuable treatment data to the oncologist in order to individualize the patient’s therapy. Microscopic specimens are then surgically implanted inorthotopic locations where they grow and metastasize. All tumors arebanked and cryogenically preserved for future therapy testing. Once passaged,tumors are cryopreserved and genetically analyzed. Copyright © Certis OncologySolutions,2018 3
4.
Landmark PDOX Study(UCLA) JCOPrecision
Oncology, 2017 Conclusions: • In the largest Soft Tissue Sarcoma PDOX study to date, we demonstrate a 62%establishment rate among untreated high- grade tumors with a median establishment time of 54 days. • Neoadjuvant therapy, particularly radiation, and pathologic response to treatment were associated with a reducedrate of PDOX establishment. Copyright © Certis OncologySolutions,2018 4
5.
PDOX vs.PDX Copyright ©
Certis OncologySolutions,2018 5 Placement of the tumor in the orthotropic location provides a more clinically relevant model ofcancer. PDOX PDXPDOX | PDX Surgical OrthotopicImplantation Subcutaneous, non-surgicalorthotopic Technology proven, innovationcontinues Commercializing patient treatment using technologyunchangedindecades Reliablymetastasizes Rarelymetastasizes Hightumor establishmentsuccessrate Lowersuccessrateof tumor growth 3-4monthsmedianintervalto establishment andtreatment recommendation; more accuratedata 6-9 months totreatment recommendation
6.
PDOX vs.PDX Copyright ©
Certis OncologySolutions,2018 6 Orthotopic models grow faster than subcutaneous models and recur more often.
7.
ConcordanceTesting Verifiedthat the response
of the mouse tumor closely matches that of the patient’s tumor • Our concordance study will be published as part of our submission for the CLIA license for HighComplexity Testing • Disease progression and subsequent metastasis mimicsthe clinical progression inhumans • Increases the accuracy of therapy and reduces the time to treat aggressive tumors • Closely simulates tumor response to each cancertreatment option • Certis PDOX’s time and accuracy provide a significant, sustainable competitive advantage over existing mousemodels Copyright © Certis OncologySolutions,2018 7 WithCertisPDOXmodels,what happensinthemicehappensin patients.
8.
Core Needle BiopsyStudy Game
changer because we will be collecting data in earlier stages of patient care • Study in progress • Does not disrupt therapy /standardprocedure • Will allow us access to patient tumors well in advance of surgical biopsy and begin establishment from the time of diagnosis • Allows for longitudinal patient studies and access to more tumor material: 1. Biopsy 2.Surgical resection 3.Recurrence Copyright © Certis OncologySolutions,2018 8
9.
Certis PDOX Preclinical
ResearchServices Drug discovery forgenetic researchers, pharmaceutical companies, biotech and academic laboratories 1. Guidance in selecting models 2. Execution of drug screening and efficacystudies 3. Individual patient drug-efficacy information 4. Data analysis and reporting 5. Assistance writing and publishingpapers 6. Assistance writing grant applications 7. Grant sub-contracting Copyright © Certis OncologySolutions,2018 9
10.
Oncology StudyEndpoints • Overall
survival • Tumor growth inhibition andregression • Evaluation of metastasis • Drug tolerance • Tissue harvest • Histological Analysis: IHC, IF,ISH, whole slideimaging, digital analysis Copyright © Certis OncologySolutions,2018 10
11.
TumorModels and Drugs
Evaluated Novel DrugsEvaluated in PDOX • Cobmetinib • Dactolisib • Entinostat • Lapatinib • Linsitinib • Nab-paclitaxel • Palbociclib • Pazopanib • Trametinib • Trastuzumab • Vemurafenib • Yondelis PDOX CancerTypes CurrentlyAvailable Cervical Colon Melanoma Pancreatic Livermetastasis •Pancreatic •Colon Sarcoma •Lipo •Leiomyo •GIST •Osteo •Synovial •Ewing’s •SpindleCell •Myxofibro Copyright © Certis OncologySolutions,2018 11
12.
Certis PDOX PreclinicalAdvantages Certis
PDOX mouse models, which require highly skilled micro surgery, are proven to accuratelyreflecthuman disease. • We are expanding our cryo-preserved tumor bank for translational research applications. • Our models are proven to be more clinically relevant than PDX. Numerous outcomes have been published in peer- reviewed scientific journals. • Our relationships with oncologists position us to track patient outcomes over time and obtain drug-resistant tumors. Copyright © Certis OncologySolutions,2018 12
13.
ClinicalRelevance PDOX008: Ewing’sSarcoma withFUS-ERG
fusionand CDKN2Adeletion 46-year-old female diagnosed with rareEwing's Sarcoma • Treated with two rounds of chemo(VCD) • En bloc resection and PDOXinitiation • 12 cycles of chemo(VCD/IE) • 8 months after chemo, scans revealed diffuse bony mets, bone marrowstudded with tumor, and severe cytopenias requiring frequent transfusions Primary Tumor Diffuse Metastasis 50 µm Copyright © Certis OncologySolutions,2018 13 50 µm PDOXretainshistologicalfeaturesoftheprimarypatienttumor. PrimaryTumor PDOXTumor
14.
ClinicalRelevance Copyright © Certis
OncologySolutions,2018 14 PDOX008: Ewing’sSarcoma withFUS-ERG fusionand CDKN2Adeletion FirstPDOXexperimentshowedsensitivitytoCDK4/6andIGF-1R inhibitors,whichwasusedtoobtainanINDforsingle-patient compassionateuseofganitumab(IGF-1Rinhibitor). Patientwasgiven8dosesofganitumabwhichgreatlyincreasedquality oflifewithnoadditionaltransfusionsneeded. SecondPDOXexperimentshowedtumorregressionafter irinotecan/temozolomidetreatment. Aftermarrowrecovery,irinotecan/temozolomidewasinitiatedwith rapid,remarkableresponse,extendingthepatient’slifeby2years.
15.
ClinicalRelevance PDOX173: Recurrenthigh-gradeleiomyosarcoma 63-year-old male
diagnosed with HG leiomyosarcoma • Treated with 2 cycles of neo adjuvant Gem/Tax,followedby surgical resection, then 4 cyclesDoxorubicin/Olaratumab • MRIleft Lower extremity shows Multifocal Recurrence • Resection of Lmedial thigh lesion to establishPDOX • Started pazopanib but progressed 10/24/17: 10.2cm x 6.9cm TUM OR 10/24/17: 4.95cm Copyright © Certis OncologySolutions,2018 15
16.
ClinicalRelevance PDOX173: Recurrenthigh-gradeleiomyosarcoma PDOX experiment
showed sensitivity totemozolomide/dacarbazine 4/10/18: 3.9cm x 3.6cm After 6 cycles ofdacarbazine, thepatient responded remarkably 4/10/18: 3.31cm 10/24/17: 10.2cm x 6.9cm TUM OR 10/24/17: 4.95cm Copyright © Certis OncologySolutions,2018 16
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Copyright © Certis
OncologySolutions,2018 17 Recent ScientificPublications Igarashi et al. Intra-arterial administration of tumor-targeting Salmonella typhimurium A1-R regresses a cisplatin-resistant relapsed osteosarcoma in a patient-derived orthotopic xenograft (PDOX) mouse model. Cell Cycle, 2017, Vol. 16, No. 12, 1164–1170 https://doi.org/10.1080/15384101.2017.1317417. Igarashi et al. Patient-derived orthotopic xenograft (PDOX) mouse model of adult rhabdomyosarcoma invades and recurs after resection in contrast to the subcutaneous ectopic model. Cell Cycle, 2017, Vol. 16, No. 1, 91–94 http://dx.doi.org/10.1080/15384101.2016.1252885. Igarashi et al. High efficacy of pazopanib on an undifferentiated spindle-cell sarcoma resistant to first-line therapy is identified with a patient-derived orthotopic xenograft (PDOX) nude mouse model. J. Cell. Biochem. 118, 2739-3743, 2017. Kawaguchi et al. Tumor-targeting Salmonella typhimurium A1-R combined with temozolomide regresses malignant melanoma with a BRAF-V600E mutation in a patient-derived orthotopic xenograft (PDOX) model. Oncotarget, 2016, Vol. 7, (No. 52), pp:85929-85936. Kawaguchi et al. Vemurafenib-resistant BRAF-V600E-mutated melanoma is regressed by MEK-targeting drug trametinib, but not cobimetinib in a patient-derived orthotopic xenograft (PDOX) mouse model. Oncotarget, Vol. 7, No. 44. Kawaguchi et a;. Tumor-Targeting Salmonella typhimurium A1-R Sensitizes Melanoma With aBRAF-V600E Mutation to Vemurafenib in a Patient-Derived Orthotopic Xenograft (PDOX) Nude Mouse Model. Journal of Cellular Biochemistry 118:2314–2319 (2017). Kawaguchi et al. Combination of gemcitabine and docetaxel regresses both gastricleiomyosarcoma proliferation and invasion in an imageable patient-derived orthotopic xenograft (iPDOX) model. Cell Cycle 16, 1063-1069, 2017. Kiyuna et al. Labeling the Stroma of a Patient-Derived Orthotopic Xenograft (PDOX) Mouse Modelof Undifferentiated Pleomorphic Soft-Tissue Sarcoma With Red Fluorescent Protein for Rapid Non-Invasive Imaging for Drug Screening. Journal of Cellular Biochemistry 118:361–365 (2017).. Murakami et al. Effective molecular targeting ofCDK4/6 and IGF-1R in a rare FUS-ERG fusion CDKN2A- deletion doxorubicin-resistant Ewing’s sarcoma in a patient-derived orthotopic xenograft (PDOX) nude- mouse model. Oncotarget 7, 47556-47564, 2016. Murakami et al. Tumor-targeting Salmonella typhimurium A1-R regresses an osteosarcoma in apatient- derived xenograft model resistant to a molecular-targeting drug. Oncotarget, 2017, Vol. 8, (No. 5), pp: 8035- 8042. Murakami et al. Recombinant methioninase effectively targets a Ewing’s sarcoma in a patient-derived orthotopic xenograft (PDOX) nude-mouse model. Oncotarget, 2017, Vol. 8, (No. 22), pp: 35630-35638. Igarashi et al. Patient-derived orthotopic xenograft (PDOX) mouse model of adult rhabdomyosarcoma invades and recurs after resection in contrast to the subcutaneous ectopic model. Cell Cycle 16, 91-94, 2017. Murakami et al. Tumor-targeting Salmonella typhimurium A1-R in combination with doxorubicin eradicate soft tissue sarcoma in a patient-derived orthotopic xenograft PDOX model. Oncotarget 7, 12783-12790, 2016. Kiyuna et al. High efficacy of tumor-targeting Salmonella typhimurium A1-R on a doxorubicin- and dactolisib- resistant follicular dendritic-cell sarcoma in a patient-derived orthotopic xenograft PDOX nude mouse model. Oncotarget 7, 33046-33054, 2016. Yamamoto et al. Efficacy of tumor-targeting Salmonella typhimurium A1-R on a melanoma patient-derived orthotopic xenograft (PDOX) nude-mouse model. PLoS One 11, e0160882, 2016. Murakami et al. Effective molecular targeting of CDK4/6 and IGF-1R in a rare FUS-ERG fusion CDKN2A-deletion doxorubicin-resistant Ewing’s sarcoma in a patient-derived orthotopic xenograft (PDOX) nude-mouse model. Oncotarget, Epub ahead of print. Kiyuna et al. Labeling the stroma of a patient-derived orthotopic xenograft (PDOX) mouse modelsof undifferentiated pleomorphic soft-tissue sarcoma with red fluorescent protein for rapid non-invasive drug screening. J.Cell. Biochem., Epub ahead of print. Kawaguchi et al. Vemurafenib-resistant BRAF-V600E mutated melanoma is regressed by MEK targeting drug trametinib, but not cobimetinib in a patient-derived orthotopic xenograft (PDOX) mouse model. Oncotarget 7, 71737-71743, 2016. Kawaguchi, et al. Tumor-targeting Salmonella typhimurium A1-R combined with Temozolomide regresses malignant melanoma with a BRAF-V600 mutation in a patient-derived orthotopic xenograft (PDOX) model. Oncotarget 7, 85929-85936, 2016.
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