Post on 05-Dec-2014
description
OncBioMune LLC
Therapeutic Vaccines – Breast and Prostate
Cancer
Novel Cancer Drugs
This opportunity is brought to you by Aagami, Inc. , a life sciences consulting firm based in the suburbs of Chicago, brings exciting opportunities from global companies having innovative technologies and products to India and Emerging Markets.
Bringing innovative cancer therapy to the world and high profitability to its partners
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• OncBioMune has a pipeline of both targeted therapies and therapeutic vaccines
• Both have been shown to be more effective and less toxic than conventional chemotherapies.
• OncBioMune is currently looking for corporate partners to further develop their technologies. They seek to develop cancer vaccines and targeted drugs through Phase II Clinical Trials.
• Return on investment estimated to be minimum 10X (e.g. Investing $5Mn would yield minimum $50Mn)
• Opportunity in innovative cancer treatments, cancer vaccines and drug technologies , that you could license and/or co-develop
• OncBioMune LLC, is a 30 year old Baton Rouge, Louisiana based biotechnology company specializing in innovative cancer treatments, has proprietary rights to a breast cancer vaccine, prostate cancer vaccine and the targeted chemotherapy Paclitaxel- Gallium-Transferrin
Opportunity in Innovative Cancer Therapy, with ROI 10x of Investment possibility
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The Pipeline:
Therapeutic Cancer Vaccines
Safety and Efficacy demonstrated by extensive internal clinical trials. Several Hundred people have received thousands of vaccines with very little toxicity.
Prostate Cancer Vaccine “Prostatac”
– In-House clinical trails have shown a 2/3 response rate
– PSA stimulates patients immune system to fight cancer
– Presently starting Clinical Trials
• Department of Defense ($ 5,200,000 over 5 years)
• Elona BioTechnologies, Inc - Protein Manufacturer
• CRO Theradex® Oncology
• Fully Funded Phase 1a/1b clinical trial hosted by the Moore’s Cancer Center at University of California San Diego Medical School
Breast Cancer Vaccine • Initially developed in 1993; in clinic use since 1994
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Lead Vaccine Candidate PSA Vaccine “Prostatac”
• Off the Shelf Vaccine Technologies
• Components
– PSA Antigen
– IL-2 Stimulates the effector cells
– GM-CSF Promotes Antigen presentation to Dendritic Cells
+ PSA IL-2 GMCSF
+
Majority of Patients had declining PSA after the Vaccine
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Sample Vaccination Responses
DIAGNOSIS DATE OF 1ST VACCINE
PSA BEFORE VACCINE
PSA AFTER 6 VACCINES
PSA AFTER 12 VACCINES
LAST PSA
(MONTHS)
Prostate Ca 06/13/97 4.10 2.40 2.50 3.50 (80)
Prostate Ca 04/22/99 1.04 0.60 0.66 0.90 (92)
Prostate Ca 07/27/99 6.80 6.40 only 6 vaccines ----
Prostate Ca 11/30/99 4.90 2.80 2.40 2.97 (42)
Prostate Ca 02/10/00 6.20 5.80 1.90 2.20 (65)
Prostate Ca 02/28/00 4.20 3.50 4.40 3.90 (18)
Prostate Ca 03/06/00 14.60 5.50 6.50 7.70 (49)
Prostate Ca 06/27/00 7.60 13.70 only 4 vaccines
Prostate Ca 08/08/00 4.00 4.93 seeds ----
Prostate Ca 03/22/01 8.95 10.60 17.19 ----
Prostate Ca 05/21/01 7.20 5.41 7.30 6.00 (28)
Prostate Ca 06/04/01 4.55 7.02 4.17 10.80 (21)
Benign Hyper 07/12/99 8.90 8.70 9.60 15.30 (13)
Prostatitis 09/23/99 6.22 5.70 6.30 ----
Results from internal clinical trial done in accordance with physician/ compounding pharmacy laws.
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Highlights & Clinical Trial
• IND # 14778 • Fully funded phase 1a/1b clinical
trial to commence the first quarter of 2013 at the UCSD Moore's Cancer Center.
• Batched cGMP PSA produced, fill finished and in storage at Bio-storage technologies.
• Animal Toxicology performed by MPI showed no toxicity.
• Phase 1a – Vaccinate 20 patients to
confirm minimal toxicity of the PSA vaccine
• Phase 1b – Enroll 28 additional patients
• Partnering with UCSD Medical Center
NCVP Phase 1a and 1b Clinical Trial Highlights - PSA Vaccine
Highlights & Clinical Trial
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Kaplan-Meier Curve Shows Improved Survival of Breast
Cancer patients with depressed immunity
Vaccination study using OBM vaccine technology
Vaccinated depressed immunity
89% (33/37)
59% (33/56)
95% (20/21)
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Treated Patient Population
Cancer Type Number of Patients
Breast 210
Prostate 26
Colon 4
Ovarian 4
Lung 4
Melanoma 2
Sarcoma 2
Stomach/Esophageal 1
Facial Skin 1
Tongue 1
TOTAL 255
*The patient population came for the Elliott-Elliott-Head Breast Cancer Research and Treatment Center.
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Drugs currently on the Market
*Estimated Revenues for 2016 in the US
Provenge $940 million
Zytiga $1,500 million
Opportunity assessment of “Prostatac”
Prostate Cancer in the US 2.2 Million Men in the US with Prostate Cancer •242,000 new cases in 2012 (NCI) •28,000 Deaths.. •845,000 of those men are undergoing androgen deprivation therapy (Bernstein Research)
*Forecasted growth at 5% per year *Forecasts from Evaluate Pharma
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5-Year Timeline for Prostatac
Phase I clinical trial for prostate cancer vaccine underway
Phase I clinical trial for prostate cancer vaccine completed
Phase II clinical trial for prostate cancer
License agreements pursued for late stage development of prostate cancer vaccine
Prostate cancer vaccine licensed
Prostatac
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Novel Cancer Drugs
Pipeline:
Paclitaxel Gallium Transferrin
+ +
“PGT”
Targeted Therapy PGT Innovative Chemotherapy
Drug
•Transferrin targets paclitaxel to cancer cells
and delivers it into the cytoplasm beyond
drug efflux protein pumps
•Avoids use of Cremophor EL in paclitaxel
preparation
•Has increased efficacy due to decreased
toxicity, and increased specificity compared
to other chemotherapeutic drugs
•Drug can be used to treat various forms of
cancer including Breast, Prostate, Ovarian
and Multiple Myeloma. Decreased Toxicity, Increased specificity
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PGT Opportunity Assessment
If PGT captures X% of
the taxane market…
Peak sales in 2023 are
estimated to be…
1% $194M
2% $387M
3% $581M
4% $775M
5% $968M
6% $1.2B
7% $1.4B
8% $1.6B
9% $1.7B
10% $1.9B
7.2%
11.9%
6.4%
2.8%
6.4%
2.2%
0%
2%
4%
6%
8%
10%
12%
14%
2008 2013 2018
DecisionResources
Sell-Side Analyst(MCF)
Note: Sell-side analyst estimate for percentage of taxane market
captured by Abraxane calculated by dividing estimated Abraxane sales
by the price of therapy per patient estimated by Decision Resources to
get number of patients on Abraxane. That figure was then divided by
the Decision Resources estimate for number of patients on taxanes
across breast, NSCLC, prostate, gastric, melanoma, and ovarian
cancers.
Estimated Percent of Overall
Taxane Market Captured by
Abraxane
Assumptions:
• The overall taxane market continues to grow at the same annual rate as
it is currently estimated by Decision Resources to grow between 2008
and 2018 in the US
• PGT generates revenue per patient per year equivalent to what Abraxane
generates currently per patient per year (no growth rate in price)
If PGT can capture just a small percentage of the taxane market in the US,
that Abraxane is expected to capture, it could be a blockbuster product.
2.8%
6.4% 7.2%
2.2%
6.4%
11.9%
0%
2%
4%
6%
8%
10%
12%
14%
2008 2013 2018
Decision Resources
Sell-Side Analyst (MCF)
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5-Year Timeline for Targeted Therapy PGT
Develop Manufacturing process for PGT
IND application filed for PGT treatment of Stage IV ovarian cancer
Phase I trial for PGT for Stage IV Ovarian Cancer I initiated
Phase I for PGT in breast cancer
Licensing agreements pursued for PGT use in Stage IV Ovarian Cancer
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The Opportunity to yield ROI of 10X
• You can In-license for India/Asia OR
• Co-develop vaccines and drugs thru Phase II Clinical Trials
• Out-license together to a Major Pharma on completion of Phase III
• This offering is sure to yield 10X of your investment made
OncBioMune is looking for
corporate partners to further develop their technologies
and products...
OR
In-license for emerging markets
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