A quick overview of Certis's unique approach to de-risking IND-enabling studies and expediting the path to clinic.

1. Precision
Oncology
Translational Drug Development

2. Certis Oncology Solutions was formed in 2016 with the mission to
provide individualized precision patient care using orthotopic
patient-derived xenografts (O-PDX).
Our patient-directed therapy enables oncologists to tailor and
optimize therapies for patients suffering from aggressive cancers.
Drug developers leverage our expertise in precision oncology to
optimize targets and expedite preclinical development.
About Certis Oncology Solutions

3. Our San Diego Laboratory is CLIA-certified
for High Complexity Testing
CLIA ID# 05D2149049

4. The Certis Advantage | O-PDX + MRI + TVM
All Certis tumor specimens are
collected from real cancer patients
Specimens are cryopreserved and fully characterized.
Our tumor database includes genetic profile, histology, patient
demographics, medical history and pharmacology
Specimens are surgically implanted in
ORTHOTOPIC locations where they grow, metastasize,
and recapitulate human tumor behavior
Multiple drug candidates are simultaneously
tested on multiple mice
This enables better informed development decisions and
well-supported IND applications, expediting time to clinic
IND
You receive precise Tumor Volume Measurement (TVM)
using murine-scale MRI + reliable pharmacology data…

5. O-PDX | The Gold Standard for Translational
Drug Development
Orthotopic models offer significant advantages
over traditional PDX and CDX models.
• Deliver the highest concordance between
human and mouse tumors.
• Allow the evaluation of anti-metastatic effects
of agents, given the propensity of orthotopically
implanted tumors to metastasize.
• Better recapitulate tumor microenvironment
than subcutaneous implanted tumors.
• Maintain histological characteristics of original
patient tissue.

6. PancreasStomach
LimbPeritoneum
Breast
Colon Liver
Brain
The Certis O-PDXTechniqueAllowsTumor Implantation
InAVariety of Organs and Tissues

7. Digital Tumor Volume Measurements (TVM)
Using Murine-scale MRI & Advanced Software
MRI provides visual proof of
tumors beyond graphs
 Quantitative
 Reproducible
 Accurate

8. The Certis O-PDX technique demonstrates concordance
and successfully predicts human response
PET Scan, 12/2016
First recurrence with
diffuse bony metastasis
and bone marrow
involvement
(ongoing O-PDX testing)
PET Scan, 4/2017
Radiologic response
with improvement of
bone marrow after
treatment with IGF-1R
inhibitor ganitumab
PET Scan, 7/2017
Decreased tumor
volume and FDG uptake
after treatment with
irinotecan/temozolomide
46 year-old female diagnosed with rare Ewing’s Sarcoma
50 µm
Primary Tumor
50 µm
O-PDX umor
O-PDX pharmacological testing results
50 µm 50 µm
O-PDX Tumor
Tumor sensitive to IGF-1Ri Tumor sensitive to IRT+TEM
Murakami et al., 2016Muyaki et al., 2017

9. MRI-derived tumor measurement broadly
applies to all tumor types
PDX3
16
Rhabdomyosarcoma-
IM Thigh
Axial
Coronal
Sagittal
Axial
Sagit
tal
Colorectal Adenocarcinoma-
Liver Metastasis
Sagittal
Rhabdomyosarcoma-
Peritoneum
Axial
Sagittal
Axial
Myxoid Liposarcoma
Liver
Rhabdomyosarcoma-
IM Thigh
Rhabdomyosarcoma-
IM Thigh
Sagittal
Gastric Carcinoma-
Gastric
Glioblastoma- Cerebrum
Lung Adenocarcinoma-
Lung
Leiomyosarcoma-
Abdomen
Coronal Coronal Coronal

10. 0 1 0 2 0 3 0
0
5 0 0
1 0 0 0
1 5 0 0
C o n t r o l
C y c l o p h o s p h a m i d e +
V i n o r e l b i n e
C y c l o p h o s p h a m i d e +
V i n o r e l b i n e + A v a s t i n
M o c e t i n o s t a t + V i n o r e l b i n e
G e m c i t a b i n e + D o c e t a x e l
T e s t D a y
TumorVolume(mm
3
)
T r a b e c t e d i n
C y c l o p h o s p h a m i d e +
V i n o r e l b i n e + A r t e s u n a t e
Treatment
Change in
Tumor
Volume
MRI Before
Treatment
MRI After
Treatment
Control 698.69%
Mocetinostat
Vinorelbine
-96.49%
Cyclophosphamide
Vinorelbine
Artesunate
-91.56%
Cyclophosphamide
Vinorelbine
Avastin
-77.52%
Cyclophosphamide
Vinorelbine
-63.39%
Gemcitabine
Docetaxel
-61.29%
Trabectedin -50.83%
In-vivo pharmacology helps identify optimal candidates
and combination treatments

11. We are rapidly growing a bank
of well-characterized tumors for research
MODEL CHARACTERISTICS

12. More than40 peer-reviewed academic
articles on
personalized oncology,
orthotopic implantation and
preclinical research
The Certis team has published more than
40 peer-reviewed academic articles
on personalized oncology, orthotopic
implantation and preclinical research.

13. Clinical Factors That Affect the Establishment of Soft
Tissue Sarcoma Patient-Derived Orthotopic Xenografts
Prior Treatment Negatively Correlates with EngraftmentHighest Establishment Rates are in Untreated HG Tumors
J Clin Oncol Precision Oncology, 2017 Aug 4 PMID: 30613825
A University of California, Los Angeles, Sarcoma
Program Prospective Clinical Trial

14. Preclinical Oncology Services

15. Preclinical Oncology Services (In Development)

16. Expert Oncology Collaborators
Jonathan Nakashima, PhD
Chief Scientific Officer
Monika Buczek, PhD
Director of Business Development
M. Phil and PhD degrees in Molecular, Cellular
and Developmental Biology. Formerly with
Champions Oncology, where she served as a
Study Director specializing in hematological
malignancies, as well as in-vitro, in-vivo, and
humanized PDX studies.
PhD degree in Molecular and Medical
Pharmacology from UCLA. Formerly with
Crown Biosciences, where he served as a Study
Director for in-vitro, and in-vivo projects
including solid tumor PDX studies and PDX
screens, and syngeneic studies.

17. Certis Oncology Solutions Is Here For You!
Monika Buczek, PhD
Director of Business Development
mbuczek@certisoncology.com
Cell: 860-986-3806
Jonathan Nakashima, PhD
Chief Scientific Officer
Nakashima@certisoncology.com
Office: 858-952-1820
Cell: 925-548-3026
www.certisoncology.com