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New Hope for New Hope for Cancertherapy: Cancertherapy: A New Drug A New Drug Combination for Combination for Chemoimmunotherapy Chemoimmunotherapy
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Page 1: New Hope for Cancertherapy

New Hope for New Hope for

Cancertherapy:Cancertherapy:

A New Drug A New Drug

Combination for Combination for

ChemoimmunotherapyChemoimmunotherapy

Page 2: New Hope for Cancertherapy

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

Page 3: New Hope for Cancertherapy

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

Page 5: New Hope for Cancertherapy

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

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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

Page 7: New Hope for Cancertherapy

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.

Page 8: New Hope for Cancertherapy

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

+

Page 9: New Hope for Cancertherapy

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

Page 10: New Hope for Cancertherapy

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

Page 11: New Hope for Cancertherapy

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)

Page 12: New Hope for Cancertherapy

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

Page 13: New Hope for Cancertherapy

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

Page 15: New Hope for Cancertherapy

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

Page 16: New Hope for Cancertherapy

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

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IP StatusIP StatusAustralia AU60177024

United States US6811788

China ZL01806830.8

Page 18: New Hope for Cancertherapy

D

INDD P C

A

BARA-C-T

ADM-T

E = Exploratory Clinical Testing

E

Automatic Injector

GEMCITABINE-T

PTX-T

Page 19: New Hope for Cancertherapy

PartnershipPartnership

Investment/Equity

Licensing

Co-development of new regimen (e.g., Tarceva-T)

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Page 20: New Hope for Cancertherapy

World Is Smaller Here

Page 21: New Hope for Cancertherapy

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