New Hope for Cancertherapy:  A New Drug  Combination for  Chemoimmunotherapy
Company Overview Found in 2003, Baofa Cancer Therapeutics Inc. includes: A R&D center for development of drug combination regimens and delivery technology Two cancer hospitals focusing on intratumoral therapy with the proprietary drug-release technology, which have treated about ten thousand patients A medical device company for development, manufacture and marketing of Ozone 260 employees
Business Focus Increasing cancer population Limited efficacy and significant side effects  of current treatments, e.g., chemotherapy Difficulty in new drug development New applications of approved drugs  Targeted Therapy:  physical  & molecular targets  Combination Therapy:  chemoimmunotherapy Personalized Cancer Therapy
TriCancerVac Cytotoxic Drug Clinically approved  Stability Adjuvant Increasing immunogenicity of tumor antigens to boost immune response Oxidant  Controlling drug-release
Targeted   TriCancerVac  is injected intratumorally under the guidance  of an imaging device such as ultrasound or CT scanner. The  procedure is straightforward as a needle biopsy and more  easily used than other intervention methods.  Technology Goldberg  2002  Intratumoral cancer chemotherapy and immunotherapy: opportunities for nonsystemic preoperative drug delivery . J Pharm Pharmacol. 54:159-80
Sustained Drug Release A clinically approved oxidant effectively coagulates tumor mass to  inhibit blood flow and entrap the injected drugs at high concentration  within the tumor (>10X conventional chemotherapy) for sustained  drug release, which improves drug utilization by extending duration  of drug action and reducing dosing frequency.   Technology
Chemoimmunotherapy The autologous tumor antigens released from the dead tumor  cells killed by cytotoxic drug trigger immune response as a self- vaccination. Adjuvant boosts systemic immunity against the patient  specific tumor antigens to suppress and eradicate tumor recurrence  and metastasis as cancer autologous vaccination.  Technology Emens LA. 2008.  Chemotherapy and tumor immunity: an unexpected collaboration.   Front Biosci. 13: 249-57. Lake RA. 2005.  Immunotherapy and chemotherapy--a practical partnership.  Nat Rev Cancer. 5(5): 397-405. Nowak AK. 2006.  Combined chemoimmunotherapy of solid tumours: improving vaccines?   Adv Drug Deliv Rev. 58:975-90.
Competitive Advantage Simple and Cost-effective   A 30-45 minute procedure; 1/2 -1/3 of the cost of standard chemotherapy; more applicable than autologous tumor vaccines and catheter interventional chemotherapy.   Clinically effective for a broad spectrum of tumors   Patients with various solid tumors including liver, lung and pancreatic cancers are treated with significant increase in survival than the control subjects without adjuvant.  Minimal side effects and better quality of life   Since drug is entrapped in the targeted tumor mass with less leakage, it causes only temporary fever (< 38 o C) for a few hours without other systemic cytotoxicity. Local  Chemotherapy Personalized Cancer Therapy Systemic  Immunity +
P < 0.05 Clinical Data   —  Liver Cancer Stage N Median Survival Time (M) Six Month Survival Rate ( % )  One Year Survival Rate ( % ) - Adjuvant Ⅱ 2 2 50 50 Ⅲ 31 4 41.94 29.03 Ⅳ 57 3 24.56 10.53 Sum 90 3.5 32.22 18.89 + Adjuvant Ⅱ 7 30.1 85.71 71.42 Ⅲ 86 7 70.93 31.39 Ⅳ 116 5.5 52.58 25.86 Sum 209 7 61.24 29.67
Clinical Data   Pancreatic Cancer Group N Six Month Survival Rate (%) p One Year Survival Rate ( % ) p +Adjuvant 25 64 > 0.05 28 < 0.05 -Adjuvant 20 45 5
Clinical Data   —  NSCLC* *Patients were treated with intratumoral therapy, followed by supportive treatment  (radiotherapy and EP Chemotherapy : CBP 0.3 d 1 , VP-16 0.1 d 1 ~ 4 ) Group Stage N Median Survival Time (M) Six Month Survival  Rate (%) One Year Survival Rate (%) - Adjuvant II 10 6.33 50 30 III 20 5.52 45 20 IV 12 4.9 41.67 33.33 Sum 42 7.59 45.23 26.19 + Adjuvant II 8 11.47 100 50 III 33 11.9 69.7 42.42 IV 11 9.77 81.82 45.45 Sum 52 12.66 76.36 45.45
Clinical Data   —  NSCLC** **Patients were treated with intratumoral therapy alone Group N Mean Survival Time (M) Median Survival Time (M) Six Month Survival Rate ( % )  One Year  Survival  Rate ( % ) -Adjuvant Ⅰ 2 22.5 4 50 50 Ⅱ 2 4.5 4.5 0 0 Ⅲ 6 3.33 2 16.67 0 Ⅳ 4 6.15 4.5 50 25 Sum 14 7.04 3.5 28.57 14.29 +Adjuvant Ⅰ 5 25.5 13 60 60 Ⅱ 2 14 11 50 50 Ⅲ 11 18.8 10 72.72 45.45 Ⅳ 7 2.86 1 28.57 0 Sum 25 15.29 9 64 36
Clinical Data     Relapsed   NSCLC Patients were treated with intratumoral therapy, followed by supportive treatment Group N Mean Survival Time (M) Median Survival Time (M) One Year Survival  Rate (% ) -Adjuvant 34 7.40 5.32 5.88 +Adjuvant 60 11.99 9.36 20.34
Clinical Data   —  Tumor Response
Clinical Data Side Effect Evaluation  SE Sum N % Ⅰ Ⅱ Ⅲ Ⅳ Nausea/Vomit 120 6 6 0 0 10 Hair Loss 120 0 0 0 0 0 Leukopenia 120 2 1 1 0 3.33
Applications Unresectable tumors Applied as preoperative treatment to reduce tumor size and to prevent metastasis Tumor recurrence or failed to early treatment Used with radiotherapy or low-dose chemotherapy to increase efficacy and reduce side effects  Used as agent for other intervention therapies
IP Status Australia  AU60177024 United States  US6811788 China  ZL01806830.8
D IND D P C A B ARA-C-T ADM-T E = Exploratory Clinical Testing   E Automatic Injector GEMCITABINE-T PTX-T
Partnership Investment/Equity Licensing Co-development of new regimen  ( e.g.,  Tarceva-T)
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New Hope for Cancertherapy

  • 1.
    New Hope forCancertherapy: A New Drug Combination for Chemoimmunotherapy
  • 2.
    Company Overview Foundin 2003, Baofa Cancer Therapeutics Inc. includes: A R&D center for development of drug combination regimens and delivery technology Two cancer hospitals focusing on intratumoral therapy with the proprietary drug-release technology, which have treated about ten thousand patients A medical device company for development, manufacture and marketing of Ozone 260 employees
  • 3.
    Business Focus Increasingcancer population Limited efficacy and significant side effects of current treatments, e.g., chemotherapy Difficulty in new drug development New applications of approved drugs Targeted Therapy: physical & molecular targets Combination Therapy: chemoimmunotherapy Personalized Cancer Therapy
  • 4.
    TriCancerVac Cytotoxic DrugClinically approved Stability Adjuvant Increasing immunogenicity of tumor antigens to boost immune response Oxidant Controlling drug-release
  • 5.
    Targeted TriCancerVac is injected intratumorally under the guidance of an imaging device such as ultrasound or CT scanner. The procedure is straightforward as a needle biopsy and more easily used than other intervention methods. Technology Goldberg 2002 Intratumoral cancer chemotherapy and immunotherapy: opportunities for nonsystemic preoperative drug delivery . J Pharm Pharmacol. 54:159-80
  • 6.
    Sustained Drug ReleaseA clinically approved oxidant effectively coagulates tumor mass to inhibit blood flow and entrap the injected drugs at high concentration within the tumor (>10X conventional chemotherapy) for sustained drug release, which improves drug utilization by extending duration of drug action and reducing dosing frequency. Technology
  • 7.
    Chemoimmunotherapy The autologoustumor antigens released from the dead tumor cells killed by cytotoxic drug trigger immune response as a self- vaccination. Adjuvant boosts systemic immunity against the patient specific tumor antigens to suppress and eradicate tumor recurrence and metastasis as cancer autologous vaccination. Technology Emens LA. 2008. Chemotherapy and tumor immunity: an unexpected collaboration. Front Biosci. 13: 249-57. Lake RA. 2005. Immunotherapy and chemotherapy--a practical partnership. Nat Rev Cancer. 5(5): 397-405. Nowak AK. 2006. Combined chemoimmunotherapy of solid tumours: improving vaccines? Adv Drug Deliv Rev. 58:975-90.
  • 8.
    Competitive Advantage Simpleand Cost-effective A 30-45 minute procedure; 1/2 -1/3 of the cost of standard chemotherapy; more applicable than autologous tumor vaccines and catheter interventional chemotherapy. Clinically effective for a broad spectrum of tumors Patients with various solid tumors including liver, lung and pancreatic cancers are treated with significant increase in survival than the control subjects without adjuvant. Minimal side effects and better quality of life Since drug is entrapped in the targeted tumor mass with less leakage, it causes only temporary fever (< 38 o C) for a few hours without other systemic cytotoxicity. Local Chemotherapy Personalized Cancer Therapy Systemic Immunity +
  • 9.
    P < 0.05Clinical Data — Liver Cancer Stage N Median Survival Time (M) Six Month Survival Rate ( % ) One Year Survival Rate ( % ) - Adjuvant Ⅱ 2 2 50 50 Ⅲ 31 4 41.94 29.03 Ⅳ 57 3 24.56 10.53 Sum 90 3.5 32.22 18.89 + Adjuvant Ⅱ 7 30.1 85.71 71.42 Ⅲ 86 7 70.93 31.39 Ⅳ 116 5.5 52.58 25.86 Sum 209 7 61.24 29.67
  • 10.
    Clinical Data Pancreatic Cancer Group N Six Month Survival Rate (%) p One Year Survival Rate ( % ) p +Adjuvant 25 64 > 0.05 28 < 0.05 -Adjuvant 20 45 5
  • 11.
    Clinical Data — NSCLC* *Patients were treated with intratumoral therapy, followed by supportive treatment (radiotherapy and EP Chemotherapy : CBP 0.3 d 1 , VP-16 0.1 d 1 ~ 4 ) Group Stage N Median Survival Time (M) Six Month Survival Rate (%) One Year Survival Rate (%) - Adjuvant II 10 6.33 50 30 III 20 5.52 45 20 IV 12 4.9 41.67 33.33 Sum 42 7.59 45.23 26.19 + Adjuvant II 8 11.47 100 50 III 33 11.9 69.7 42.42 IV 11 9.77 81.82 45.45 Sum 52 12.66 76.36 45.45
  • 12.
    Clinical Data — NSCLC** **Patients were treated with intratumoral therapy alone Group N Mean Survival Time (M) Median Survival Time (M) Six Month Survival Rate ( % ) One Year Survival Rate ( % ) -Adjuvant Ⅰ 2 22.5 4 50 50 Ⅱ 2 4.5 4.5 0 0 Ⅲ 6 3.33 2 16.67 0 Ⅳ 4 6.15 4.5 50 25 Sum 14 7.04 3.5 28.57 14.29 +Adjuvant Ⅰ 5 25.5 13 60 60 Ⅱ 2 14 11 50 50 Ⅲ 11 18.8 10 72.72 45.45 Ⅳ 7 2.86 1 28.57 0 Sum 25 15.29 9 64 36
  • 13.
    Clinical Data Relapsed NSCLC Patients were treated with intratumoral therapy, followed by supportive treatment Group N Mean Survival Time (M) Median Survival Time (M) One Year Survival Rate (% ) -Adjuvant 34 7.40 5.32 5.88 +Adjuvant 60 11.99 9.36 20.34
  • 14.
    Clinical Data — Tumor Response
  • 15.
    Clinical Data SideEffect Evaluation SE Sum N % Ⅰ Ⅱ Ⅲ Ⅳ Nausea/Vomit 120 6 6 0 0 10 Hair Loss 120 0 0 0 0 0 Leukopenia 120 2 1 1 0 3.33
  • 16.
    Applications Unresectable tumorsApplied as preoperative treatment to reduce tumor size and to prevent metastasis Tumor recurrence or failed to early treatment Used with radiotherapy or low-dose chemotherapy to increase efficacy and reduce side effects Used as agent for other intervention therapies
  • 17.
    IP Status Australia AU60177024 United States US6811788 China ZL01806830.8
  • 18.
    D IND DP C A B ARA-C-T ADM-T E = Exploratory Clinical Testing E Automatic Injector GEMCITABINE-T PTX-T
  • 19.
    Partnership Investment/Equity LicensingCo-development of new regimen ( e.g., Tarceva-T)
  • 20.
  • 21.