New Hope for Cancertherapy
Transcript of New Hope for Cancertherapy
New Hope for New Hope for
Cancertherapy:Cancertherapy:
A New Drug A New Drug
Combination for Combination for
ChemoimmunotherapyChemoimmunotherapy
Company OverviewCompany 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 FocusBusiness 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
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TriCancerVac
Cytotoxic Drug• Clinically approved
• Stability
AdjuvantIncreasing
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.
TechnologyTechnology
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.
TechnologyTechnology
ChemoimmunotherapyThe 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.
TechnologyTechnology
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 AdvantageCompetitive 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 (< 38oC) for a few hours without other systemic cytotoxicity.
Local Chemotherapy
PersonalizedCancer Therapy
Systemic Immunity
+
P < 0.05
Clinical DataClinical Data — — Liver CancerLiver Cancer
Stage NMedian Survival Time (M)
Six Month Survival
Rate (% )
One Year Survival
Rate (% )
-Adjuvant
Ⅱ 2 2 50 50Ⅲ 31 4 41.94 29.03Ⅳ 57 3 24.56 10.53
Sum 90 3.5 32.22 18.89
+Adjuvant
Ⅱ 7 30.1 85.71 71.42Ⅲ 86 7 70.93 31.39Ⅳ 116 5.5 52.58 25.86
Sum 209 7 61.24 29.67
Clinical DataClinical Data Pancreatic CancerPancreatic Cancer
Group NSix Month
Survival Rate (%)
pOne Year
Survival Rate (% )
p
+Adjuvant 25 64 >0.05
28 < 0.05-Adjuvant 20 45 5
Clinical DataClinical Data — — NSCLC*NSCLC*
Group Stage NMedian 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
*Patients were treated with intratumoral therapy, followed by supportive treatment
(radiotherapy and EP Chemotherapy : CBP 0.3 d1 , VP-16 0.1 d1 ~ 4)
Clinical DataClinical Data — — NSCLC**NSCLC**
Group NMean
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
**Patients were treated with intratumoral therapy alone
Clinical DataClinical Data RelapsedRelapsed NSCLCNSCLC
Group NMean 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
Patients were treated with intratumoral therapy, followed by supportive treatment
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Clinical DataClinical Data — — Tumor ResponseTumor Response
SE SumN
%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
Clinical DataClinical DataSide Effect Evaluation Side Effect Evaluation
ApplicationsApplications
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 StatusIP StatusAustralia AU60177024
United States US6811788
China ZL01806830.8
D
INDD P C
A
BARA-C-T
ADM-T
E = Exploratory Clinical Testing
E
Automatic Injector
GEMCITABINE-T
PTX-T
PartnershipPartnership
Investment/Equity
Licensing
Co-development of new regimen (e.g., Tarceva-T)
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