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POSSIBLE SYNERGIES BETWEEN WESTERN AND TRADITIONAL CHINESE MEDICINES ACADEMIC ROUNDTABLE ORGANIZED UNDER THE AUSPICES OF THE CZECH MINISTRY OF HEALTH ROUNDTABLE 2 - “TCM AS SCIENCE AND EVIDENCE-BASED CLINICAL PRACTICE” Prof. Radek Špíšek, MD, PhD, Chief Scientist, SOTIO a.s. FEBRUARY 23, 2017 Cancer immunotherapy- breakthrough of the year DCVAC/LuCa 1• Patient visits leukapheretic center where his blood is used to… 2• … separate monocytes and grow immature DCs 3• Tumor cell line1 is prepared and killed by immunogenic death 4 4• Immature DCs are mixed with killed tumor cells 5• Mature DCs are prepared 3 All processes need state of the art scheduling and logistics 1 Acquired from ATTC 6• ~18 doses of DCVAC/LuCaare produced and frozen in liquid nitrogen 7 • Patient receives vaccine on an ongoing basis (1 shot per month) DC- T cell interaction in the lymph nodes High CRT expression correlates with better overall survival in NSCLC • Heterogenous distribution of CRT expression among different patient´s tumors independent on the histological origin of the tissue and administered chemotherapy • CRT expression is associated with better prognosis – the median of CRTLo group was 28 months compared to CRTHi groups with 100 months Fucikova, Cancer Research, 2016 Fucikova, Blood 2016 SOTIO DCVAC Ongoing Program Prague / Boston Product Technology DCVAC/PCa DC immunotherapy DCVAC/OvCa DCVAC/LuCa DC immunotherapy DC immunotherapy Company Pre-clinical Phase I Phase II Phase III VIABLE study Multiple trials in different settings Multiple trials in different settings One trial in NSCLC Stage IV 6 GMP facility, Beijing: 18 clean boxes Manufacturing for China Huilongseng International Enterprise Incubator, Beijing, Yizhuang Chinese ongoing Hospital Research Projects Project size Patients Enrolled (2017-JAN-20) Beijing Tongren Hospital A Safety Study of DCVAC/PCa in Men with Metastatic Castration Resistant Metastatic Castration Prostate Cancer Eligible for 1st Line Resistant Prostate Cancer Chemotherapy 10 7 China-Japan Friendship Hospital A Study on DCVAC/PCa Immunotherapy in Men with Asymptomatic or Minimal Symptomatic Metastatic Castration Resistant Prostate Cancer Asymptomatic or Minimal Symptomatic Metastatic Castration Resistant Prostate Cancer 10 8 Metastatic Non-small Cell Lung Cancer 13 13 Hospital Project Name Safety and Efficacy Study of China-Japan Friendship DCVAC/LuCa Concurrent Hospital Chemotherapy in Metastatic Nonsmall Cell Lung Cancer Indication 8 ILU03: Treatments • SoC chemotherapy • Investigators can choose from the following SoC regimens: • paclitaxel/carboplatin administered on Day 1 q3 weeks • gemcitabine/cisplatin administered on Day 1 (gem. also on Day 8) q3 • • • weeks • pemetrexed/cisplatin administered on Day 1 q3 weeks • pemetrexed/carboplatin on Day 1 q3 weeks Maintenance treatment possible with pemetrexed monotherapy DCVAC/LuCa • Administered from the 2nd cycle of SoC, initially in a 3-week cycle (5 times) and then in a 6-week cycle schedule (for the remainder of the treatment) • Up to 15 doses can be administered, but 10 delivered doses would be acceptable Shenqi Fuzheng infusion • Shenqi Fuzheng infusion should be administered 3 days before each DCVAC/LuCa administration and until a total of 14 daily doses have been administered • The Shenqi Fuzheng infusion schedule is applicable during both 3-week and 6-week DCVAC/LuCa administration schedules. SOTIO - CONFIDENTIAL 9 ILU03: A single-arm phase II study to evaluate efficacy, safety, and immune response of first-line treatment with Shenqi Fuzheng infusion, DCVAC/LuCa, and standard of care chemotherapy in patients with recurrent metastatic or advanced (stage IIIB or IV) non-small cell lung cancer • • Combining platinum-based chemotherapy with Chinese medicinal herbs (e.g., Shenqi Fuzheng infusion) for the treatment of advanced NSCLC may improve tumor response and performance status, as well as reduce chemotherapy toxicity.* The traditional Chinese medicine (TCM) tested in this study, Shenqi Fuzheng infusion, is concocted from two kinds of Chinese medicinal herbs: Radix Astragali (root of Astragalus propinquus; Chinese name: huangqi) and Radix Codonopsis (root of Codonopsis pilosula; Chinese name: dangshen), approved by the State Food and Drug Administration of the People’s Republic of China in 1999 primarily as an antitumor injection to be manufactured and marketed in China.* * Dong J, Su S-Y, Wang M-Y, Zhan Z. Shenqi fuzheng, an injection concocted from Chinese medicinal herbs, combined with platinum-based chemotherapy for advanced non-small cell lung cancer: a systematic review. Journal of experimental & clinical cancer research: CR. 2010;29. SOTIO - CONFIDENTIAL 10 ILU03: A single-arm phase II study to evaluate efficacy, safety, and immune response of first-line treatment with Shenqi Fuzheng infusion, DCVAC/LuCa, and standard of care chemotherapy in patients with recurrent metastatic or advanced (stage IIIB or IV) non-small cell lung cancer • • We hypothesize that immunization with DCVAC/LuCa might induce the effector cells of the immune system to infiltrate tumors. The resulting immune reaction may lead to tumor mass reduction. Addition of Shenqi Fuzheng infusion to DCVAC/LuCa and SoC chemotherapy may reduce the toxicity of chemotherapy and enhance the anti-tumor immune responses SOTIO - CONFIDENTIAL 11 Patients treated with combination of DCVAC/LuCa, TCM, and Chemotherapy • • • Median PFS is 12.6 months • [expected median PFS 5.0-6.5 months] Median survival is not reached with only 3 events and 6 censored pts • median follow-up in surviving patients = 18.8 months • [expected median survival 9.0-17.0 months] 1 year survival is currently 89% and 18 months survival is currently 67% • [expected 1 year survival 60-65%] SOTIO - CONFIDENTIAL 12 China Clinical Studies: ILU02 and ILU03 Hospital Study Name ID A randomized phase II study to evaluate efficacy and safety of DCVAC/LuCa added to Shanghai chemotherapy with carboplatin and ILU02 Chest Hospital pemetrexed vs chemotherapy alone in patients with stage IV non-small cell lung cancer A single-arm phase II study to evaluate efficacy, safety, and immune response China-Japan of first-line treatment with Shenqi Fuzheng Friendship infusion, DCVAC/LuCa, and standard of care ILU03 Hospital chemotherapy in patients with recurrent metastatic or advanced (stage IIIB or IV) nonsmall cell lung cancer Setup Indication Size Patients Enrolled Phase II stage IV non-small cell lung cancer 70 36 (2017-JAN-20) stage IIIB or IV nonPhase II small cell lung cancer 48 1 (2017-JAN-20) 13