OBI Pharma presentation at JP Morgan Healthcare Conference 2018 - Chinese Version
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Chinese version of the slide deck used at the 36th Annual JP Morgan Healthcare Conference in San Francisco from 8 to 11 Jan 2018
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OBI Pharma presentation at JP Morgan Healthcare Conference 2018 - Chinese Version
- 1. The 36th J.P. Morgan Annual Healthcare Conference 2018年1月 9~11日, 美國舊金山
- 2. Safe Harbor Statement This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. OBI Pharma cautions that this foregoing list of factors is not exhaustive. There may also be other risks that management is unable to predict at this time that may cause actual results to differ materially from those in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. OBI undertakes no obligation to update publicly or revise any forward-looking statements. Any statements regarding earnings growth is not a profit forecast and should not be interpreted to mean that OBI’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed published earnings or earnings per share forecasts of OBI Pharma, Inc. 2
- 3. 3 … with an innovative and balanced portfolio Re-inventing OBI as a Global Oncology Company…
- 4. OBI進期主要進展 Adagloxad Simolenin邁向全球三期臨床試驗 於美國FDA及歐盟EMA完成有建設性的二期臨床試驗完成後會議 中國CFDA通過臨床試驗申請 擴展產品線組合 由癌症主動免疫延伸到被動免疫療法 引進非醣產品 (OBI-3424) 進入產品線 參與國際型會議,提昇國際知名度 美國臨床腫瘤學會口頭報告與歐洲腫瘤醫學學會研討會 佈局未來 建構全球智財佈局 網羅國際專家人才 3
- 6. OBI-822-001臨床試驗的重要發現 Months since randomized ProbabilityofProgression-FreeSurvival IgG >=1:160 IgG <1:160 無惡化存活期 - Globo系列 免疫抗體產生 與否 安全耐受性良好 可誘發顯著的 Globo 系列 免疫抗體 5
- 10. OBI-822全球三期臨床試驗規劃 三陰性乳癌- 術前先導性化學 治療之後的 殘存疾病 試驗組 Adagloxad Simolenin 對照組 Placebo 主要終點 無疾病存活期 次要終點 整體存活期 探索性終點 腫瘤 Globo H表現與臨床結果的相關性 9
- 12. 抗體相關產品: 單株抗體及抗體小分子藥物複合體 Globo H 免疫療法 Adagloxad Simolenin 類別中第一個 癌症主動免疫療法 OBI-888 Globo H 單株抗體 (mAB) OBI-999 Globo H 抗體小 分子藥物複合體 (ADC) 聚焦於新穎 Globo H免疫療法 的創新癌症治療產品組合 12
- 13. OBI-888 –新穎的 Globo H 抗體被動免疫療法 13 抑制血管生成 抑制T細胞免疫 抑制現象 抗體依賴性細胞媒介 的毒殺作用 補體依賴細胞毒性 Cancer Res. 2016. AACR Special Conference Abstract A20. Cancer Res. 2014. 74(23): 6856-66. J Cancer Sci Ther. 2013. 5(7): 264-70 Globo H Antigen & Epitope Globo H confirmed by glycan screening and competitive ELISA GalNAc Gal Glc Fuc
- 14. OBI-888 在動物實驗中有顯著的抗癌作用 14 乳癌動物模式 MCF7 Xenograft -82% 10mg/kg -70% -27% 3mg/kg 1mg/kg Globo H Over-expression Globo H Antigen Cell Nuclei
- 15. OBI-888 為具潛力的 Globo H 抗體療法 15 獨特的治療方法 顯示抗增殖活性 計劃2017年底申 請人體臨床試驗 全球癌症藥品市 場以單株抗體為 主流 增強OBI全球癌 症藥品組合 於人類腫瘤移植的動 物實驗: 乳癌,胰臟癌,胃癌,肺 癌,大腸癌
- 17. ADC 成功取決於各部分的最佳化 抗體 特異性 抗體與標的 結合之親合力 未改變 抗體 特異性 抗體與標的 結合之親合力 未改變 標的 腫瘤特異性 標的在腫 瘤表面有 高度表現 標的 腫瘤特異性 標的在腫 瘤表面有 高度表現 連結器 血漿中必須 穩定 可被內吞進 細胞中 連結器 血漿中必須 穩定 可被內吞進 細胞中 小分子藥物 有效力 藥物可被釋 放出來 小分子藥物 有效力 藥物可被釋 放出來 17
- 18. ADC經由腫瘤特異性抗原遞送有效的 細胞毒殺藥物 18 失效 失效 效力 效力 毒性 毒性 0% Free Drug ADC 藥物劑量 治療劑量範圍更大 較少接觸到正常 組織 更多的藥物到達 腫瘤
- 19. OBI-999: 具有高市場潛力及價值 ADC 高市場成長潛力 $181億美金 (2022年) 19 ADC Market: Dublin, Feb. 22, 2017 (GLOBE NEWSWIRE) Projected value: Evaluate Pharma worldwide review 2017
- 20. 引進OBI-3424,產品更多元化 Formerly TH-3424 Globo 系列免疫療法 Adagloxad Simolenin 類別中第一個 癌症主動免疫療法 OBI-888 Globo H 單株抗體 (mAb) OBI-999 抗體小分子藥物 複合體 (ADC) AKR1C3 標靶治療 OBI-3424 小分子藥物 針對AKR1C3酶 21
- 21. 1.Guise et al., Cancer Res 70: 1573, 2010; AACR Annual Meeting 2016, Abstract #1369; Threshold in-house data Overcomes Resistance Multiple Indications Planned IND 1Q 2018 OBI-3424 – Highly Tumor Selective and First-in- Class Pro-drug Activated by AKR1C3 Enzyme Adequate Pre-Clinical Safety Margin 21 Big Market Potential 於肝癌抗性動物模 型有效 (Sorafenib 抗藥性) 標的表達於多種 癌症1 優異的動物實驗抗 腫瘤活性 於靈長類得到無毒 性有效劑量範圍 一線和二線治療 的潛力
- 23. OBI-3424比 Sorafenib具更強的抗癌作用 0 4 7 11 14 18 21 25 28 32 35 Days TumorArea(mm2) 2 4 6 8 10 12 14 Saline Sorafenib OBI-3424 1.25 OBI-3424 2.5 23 可觀察到 顯著差異 NOTE: Doses in mg/kg SOURCE: Duan et al., Broad In Vitro and In Vivo Antitumor Activity of TH-3424: Preclinical Rationale for a Highly Selective AKR1C3 Prodrug for Treating Cancer AACR Annual Meeting 2016, Abstract #1369
- 24. PDX Model (T-ALL 31) Control Group OBI-3424 Treated Group OBI-3424組的白血病骨髓浸潤明顯降低 實驗組小鼠與控制 組小鼠在無事件存 活期（Event-Free Survival, EFS）有 明顯差異 耐受良好 Days post-treatment initiation %huCD45+inthePB 為一以AKR1C3酵素為生物標記，治療侵襲性以及對化療有抗藥性之T細胞急性淋巴性白血病之新穎療法
- 25. Results of a Patient-Derived Xenograft (PDX) Study of OBI-3424 in T-cell Acute Lymphoblastic Leukemia (T-ALL) Presented at the AACR “OBI-3424 is one of the most effective drugs we have ever tested against T-ALL in over 12 years of evaluating drugs at the Children's Cancer Institute in Australia using preclinical models of aggressive childhood ALL. We are incredibly excited about the potential for OBI- 3424 to improve the treatment and quality of life for patients with this aggressive type of cancer and look forward to having this potential evaluated in clinical trials.” Professor Richard B. Lock Head of the Leukemia Biology Program Children's Cancer Institute in Australia
- 26. 計畫 適應症 臨床前 第一期 第二期 第三期 Adagloxad Simolenin 三陰性乳癌 OBI-888 mAb 上皮細胞癌 OBI-3424 Target Therapy 多種癌症 OBI-999 ADC 上皮細胞癌 OBI 新穎癌症產品線的最新狀況- 依發展階段 26
- 28. OBI與圓祥合併綜效 抗體工程技術 免疫原性較低 更好的表現 更高的親和力 抗體篩選及抗體工程 • 全人源抗體篩選 • 抗體的人源化與最佳化 • 雙特異性抗體 • 將加速浩鼎抗體開發與 強化產品組合
- 29. 29 提昇國際知名度
- 30. Adagloxad Simolenin臨床數據分別發 表於極具聲望之癌症會議 30 Dr Rugo 報告臨床數據結果 由 Dr Johnston 主持第一次 Adagloxad Simolenin 研討會 3–7 JUNE 2016 7–11 OCTOBER 2016 諮詢委員會會議 乳癌研討會一對一會議 Clinical Professor Hope S. Rugo of the Helen Diller Family Comprehensive Cancer Center at UCSF Professor Stephen Johnston of The Royal Marsden NHS Foundation Trust
- 32. 32 全球智財佈局
- 33. OBI 堅實的全球智財資產 Europe China Taiwan Japan Australia Canada United States Argentina India Mexico Chile Brazil Russia Malaysia Singapore Thailand New Zealand South Africa Israel Philippines Korea 已核准全球專利 審查中專利 107*63* 33 *註:包含授權方之專利
- 34. 34 網羅國際專家人才
- 35. 浩鼎顧問委員會的新成員 35 Russell Greig, PhD Global Biotech Big Pharma R&D VC/PE Perspective Chi-huey Wong, PhD Global Pioneer in Glycan Science Taiwan Biotech Thought leader Tillman Pierce, MD Global Clinical Trials Protocol Design Biotech R&D
- 36. Michael Chang, PhD 創始人 & 主席 Amy Huang 總經理 經驗豐富的全球管理團隊 Tony Yu 研發長 Kevin Poulos 商務長 Max Chan 營運長 Mitch Che 營運長 OBI USA Cristina Chang 全球臨床開發 和醫療事務 副總 David Hallinan 全球醫藥法規 副總 Sophia Lee 統計副總 37
- 38. Thank you San Diego Green Flash