Oncotherapy Science, Inc. · TSE:4564
Oncotherapy Science — Investor Day (December 2015)
32 slides from Oncotherapy Science's investor day presentation, Dec 18, 2015
Slide 1: R&D Day meeting
OncoTherapy Science, Inc. R&D Day meeting President & CEO, Masaharu Mori Dec .18th, 2015 1
Slide 2: Our Mission
Our Mission ONE “To develop anti-cancer medicine and cancer therapy with high efficacy and minimum risk of adverse events, and to win the war against cancer”
Slide 3: Contents
Contents １）Overview of Anti-cancer Market ２）Features and Management Policy ３）Pipelines and Updates ４）R&D Updates Small Molecular Drugs Cancer Precision Medicines Antibody Drug 3
Slide 4: Anti-cancer market with double digit growth
Anti-cancer market with double digit growth Anti-cancer market becomes 3 times bigger due to launch of molecular target drug blockbusters during last decade Sales of anti-cancer market (Global) Mil USD 90,000 80,000 CAGR 11% 3億ドル未満 Less than 3 Mil. USD 70,000 60,000 3～10億ドル 3 ~ 10 Mil. USD 50,000 （3
Slide 5: High Attention to Cancer Immunotherapy
High Attention to Cancer Immunotherapy Big success of immune checkpoint inhibitors attract attention to cancer immunotherapy, with the advent of NGS* genome analysis Target Specific（pin point） Non specific Molecular target drug Cytotoxic Cancer Cell - Small molecule chemotherapy - Antibody （Poison
Slide 6: Contents
Contents １）Overview of Anti-cancer Market ２）Features and Management Policy ３）Pipelines and Updates ４）R&D Updates Small Molecular Drugs Cancer Precision Medicines Antibody Drug 6
Slide 7: Genome-based Drug Discovery Platform Technologies
Platform Technologies → Genome-based Drug Discovery With our platform technologies, providing comprehensive gene expression profile analyses and gene function analyses, we have identified suitable target genes to develop new anti-cancer medicines with a minimal risk of adverse events. 1. A large num
Slide 8: Genome-based Drug Discovery and Development of Novel Anti-Cancer Drugs
Genome-based Drug Discovery and Development of Novel Anti-Cancer Drugs Small Molecule Drugs Genome data OTS167 OTS964 etc. Identification Phase I study in US. Pre-clinical study. of target genes Comprehensive gene expression profile comparing cancer and normal cells Cancer Peptide Vaccines Genome Ge
Slide 9: OTS's R&D strategy
OTS’s R&D strategy •Create a series of innovative new drugs using our novel platform technologies ⇒ Genome-based drug discovery •Small molecule drug: Gather good clinical data at global clinical studies, while closely cooperating with top-tier researchers in the University of Chicago and other renow
Slide 10: Management Policies and Strategies
Management Policies and Strategies １. Continue deep basic research Own research＋Collaboration with Univ. of Chicago etc. ２. Promote genome-based drug discovery Small molecule drug, Cancer peptide vaccine, Antibody ３. Promote development by well designed clinical studies Our own activity＋Partne
Slide 11: Contents
Contents １）Overview of Anti-cancer Market ２）Features and Management Policy ３）Pipelines and Updates ４）R&D Updates Small Molecular Drugs Cancer Precision Medicines Antibody Drug 11
Slide 12: Pipelines (as of Dec., 2015)
Pipelines （as of Dec., 2015） Target / Basic Lead Pre- Product Phase I Phase II Phase III Indication Research Optimization clinical Small Molecule OTS167 MELK OTS964 etc. TOPK First-in-class - identified 5 targets S-588410 * Esophageal Licensing-out Cancer to Shionogi Cancer Vaccines Bladder (Licensi
Slide 13: Highlight of this year (June ~ Nov., 2015)
Highlight of this year（June ~ Nov., 2015） Small molecular drug MELK Conducting phase I study of OTS167-IV in the University of Chicago. Additional oral administration study of OTS167-PO was approved .（Jun., 2015） TOPK Publication from collaborative group in the Univ. of Chicago shows TOPK
Slide 14: Contents
Contents １）Overview of Anti-cancer Market ２）Features and Management Policy ３）Pipelines and Updates ４）R&D Updates Small Molecular Drugs Cancer Precision Medicines Antibody Drug 14
Slide 15: Clinical Study of OTS167 (MELK inhibitor)
Clinical Study of OTS167(MELK inhibitor ） On-going Phase I Clinical study （Univ. of Chicago） Indication: Refractory advanced/metastatic solid tumors Route of Administration： On-going; Intravenous (IV) Additional; Oral administration（approved June, 2015） Objective: Primary endpoint: To d
Slide 16: New Anti-Cancer Drug Target: MELK
New Anti-Cancer Drug Target: MELK Highly expressed MELK contributes to maintain cancer stem cell. OTS167 Self-renewal Cancer stem cell Chemotherapy resistant Cancer cells Cancer Cancer Cancer cell cell cell Chemotherapy sensitive MELK New Anti-cancer drug target. OTS167(MELK inhibitor) is effect
Slide 17: MELK Selectively Overexpressed in Various Cancer Cells
MELK Selectively Overexpressed in Various Cancer Cells MELK (maternal embryonic leucine zipper kinase) is highly and selectively overexpressed in various human cancer cells. No or low expression in normal human organs except testis. Expression of MELK (cDNA microarray) Positive rate Tumor type (
Slide 18: OTS167 - MELK specific inhibitor -
OTS167 - MELK specific inhibitor - OTS167 inhibition curve ● High inhibition activity against MELK 100 ・ IC50* = 1.1 nM 80 % Inhibition IC50 of approved kinase inhibitor 60 40 Erlotinib； Tarceva ®(CHUGAI PHARMA.) 2 nM (EGFR) Sorafenib；Nexavar® （Bayer） 6 nM (c-Raf) 20 Sunitinib； Sutent® （Pfizer） 9 nM
Slide 19: OTS167 in vivo: Tumor with MELK selectively suppressed
OTS167 in vivo: Tumor with MELK selectively suppressed OTS167 shows significant MELK-dependent tumor growth suppression in xenograft model by oral administration. A549 lung cancer PC14 lung cancer (MELK high) (MELK low) Vehicle Vehicle 500 OTS167 10 mg/kg q.d. 1000 OTS167 10 mg/kg q.d. Tumor volume
Slide 20: OTS167 in vivo: IV Administration
OTS167 in vivo: IV Administration OTS167 has strong growth suppression with no severe adverse events, compare to Paclitaxel. Intravenous administration: once daily (A549 xenograft model) Tumor volume (n = 6) Body weight 600 1.2 Relative body weight Tumor volume (mm3) 500 1.1 TGI=51% 400 1 300 TGI=91
Slide 21: OTS167 in vivo: Oral Administration
OTS167 in vivo: Oral Administration OTS167 is more effective for tumor growth suppression than Paclitaxel with no severe side effects such as loss of body weight. Oral administration: once or twice daily (A549 xenograft model) Tumor volume (n = 6) Body weight 500 1.2 Tumor volume (mm3) Relative body
Slide 22: New Anti-Cancer Drug Target: TOPK
New Anti-Cancer Drug Target: TOPK TOPK is involved in cancer cell cytokinesis during mitosis TOPK Entry to Mitosis p OTS964etc Histone H3 p p p TOPK Mitosis p p97 p47 Mitosis Exit to Mitosis TOPK TOPK New Anti-cancer drug target. Several anti-cancer drugs which target mitosis are already approve
Slide 23: TOPK Highly Expressed in Various Human Cancers
TOPK Highly Expressed in Various Human Cancers TOPK is highly expressed in various human cancers, including lung and breast cancers. TOPK is not expressed in human vital organs. Expression of TOPK (cDNA microarray) Breast cancer cell lines Normal organs Positive rate Tumor type (%) * Bladder Can
Slide 24: TOPK Expressed in AML as well
TOPK Expressed in AML as well. AML cell lines AML patients Modified form Alachkar, et al., Oncotarget (2015) 24
Slide 25: OTS964 in vivo: Oral Administration
OTS964 in vivo : Oral Administration OTS964 shows significant anti-tumor effect LU99（human lung cancer） xenograft model (N=6) Once a day, 14 days, PO (orally), OTS964 100mg/kg Tumor 腫瘍の大きさvolume Body weight Control group コントロール（対照群） 体重 OTS964 100 mg/kg 経口 PO once a day 1回/1日 コントロール（対照群） Control
Slide 26: Actions for Cancer Precision Medicine
Actions for Cancer Precision Medicine 1) Cancer immunotherapy and genome 2) Launch of TCR analysis service 3) Novel immunotherapy based on genomic analysis; Precision Medicine 26
Slide 27: Cancer Immunotherapy and Genome
Cancer Immunotherapy and Genome • It was reported about 20 years ago that the patients with hereditary colon cancer caused by mutation of DNA repair gene have better prognosis than those with common type of colon cancer. ⇒ From this relationship between cancer and gene mutation, we can propose a hyp
Slide 28: Actions for Cancer Precision Medicine: Launch of TCR analysis service
Actions for Cancer Precision Medicine 2) Launch of TCR analysis service After the first half of this fiscal year of preparation, we posted revenues since this September. We promoted public awareness through conference presentation and BioJapan luncheon seminar. We received orders from the rese
Slide 29: TCR analysis: solving issues of cancer immunotherapy
TCR analysis: solving issues of cancer immunotherapy Immunomonitoring Establishment of “diagnostic marker (TCR analysis)” that reflects the change of immune state effected by therapy. ➡Rapid and quantitative evaluation of therapy contributes accurate judgment of continuation/cessation of treatment
Slide 30: Novel Therapy based on Immunopharmacogenomics
Novel Therapy based on Immunopharmacogenomics Immunecheckpoint inhibitors are now under developing, and hereafter, therapy of activating immune system and enhancing the attack against tumor will become important. 30 Source： Bio Japan 2015 luncheon seminar by Professor Nakamura, University of Chicago
Slide 31: Clinical Development Status of OTSA101
Clinical Development Status of OTSA101 On-going phase I clinical trial for synovial sarcoma, in France Under the direction of Professor Jean-Yves BLAY (former President of European Organization for Research and Treatment of Cancer; EORTC) who is global key opinion leader in sarcoma treatment.
Slide 32: based on management‘s assumptions and beliefs in light of the
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