ONCBIOMUNE LLC                                      To be read in conjunction with OncBiomune Presentation                ...
ONCBIOMUNE LLC                                                                                        Technology Descripti...
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Onc Biomune Company & Tech Brief


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OncBioMune LLC, a Baton Rouge, Louisiana based biotechnology company specializing in innovative cancer treatments, has proprietary rights to a breast cancer vaccine (patent #5,478,556 and patent application #20120282215) and prostate cancer vaccine (patent application #20120282216), and the targeted chemotherapy Paclitaxel- Gallium-Transferrin (patent application #20110190204). OncBioMune’s principals, Robert L. Elliott, M.D., Ph.D., Jonathan F. Head, Ph.D., have shown that OncBioMune’s technologies are safe, and utilize proven methods of treatment to provide optimal success for patients.

OncBioMune’s stand-alone technologies, utilizing transferrin transport technology and cancer vaccine technology, are applicable to other solid tumors, as well. The technologies of OncBioMune began with diseases of the breast as their foundation, but also provide platforms for prostate cancer and other solid tumors. The forecasted start up potential and the projected market for The Company’s products are optimal for success in the biotechnology industry.

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Onc Biomune Company & Tech Brief

  1. 1. ONCBIOMUNE LLC To be read in conjunction with OncBiomune Presentation Company BriefDeveloping Targeted Therapies to Fight Cancer www.oncbiomune.com COMPANY DESCRIPTION – OncBioMune, LLC is a biotechnology company developing cancer vaccines and targeted cancer therapies. The company’s founders, Robert Elliott, M.D., MANAGEMENT Ph.D. and Jonathan Head, Ph.D., have developed a portfolio of promising cancer therapies CEO / Medical Director that includes two vaccines for patients with breast and prostate cancer (both evaluated in Robert Elliott, M.D., Ph.D. Phase I/II clinical studies) and four transferrin based novel drugs (three evaluated in Phase I President / Director of Research studies) that attack cancer tumors specifically and therefore have greater efficacy and less Jonathan Head, Ph.D. toxicity than conventional chemotherapy. Chief Financial Officer/ EVP Their work has been conducted at the Elliott-Elliott-Head Breast Cancer Research and Andrew A. Kucharchuk, MBA Treatment Center (EEH BCRTC) in Baton Rouge, where they treat patients with cancer daily. OncBioMune was established in 2005 to further the clinical development of the cancer treatments and to pursue licensing or acquisition of its therapies and proprietary technologies. INDUSTRY Immunotherapy / Cancer Therapy BUSINESS STRATEGY – OncBioMune will develop its cancer therapies to the point where Research & Development they hold significant value for licensing or acquisition. Initial investment will be used to confirm the results already demonstrated in clinical trials at EEH BCRTC with independently conducted Phase I and Phase II clinical trials. The company will then license or sell the DRUGS IN DEVELOPMENT products or collaborate with pharmaceutical or biotech companies for late stage development (Phase III clinical trials, FDA approval) and commercialization. Clinical Development Prostate Cancer Vaccine CLINICAL STRATEGY – The prostate cancer vaccine is the company’s most developed Breast Cancer Vaccine product. A Phase I /II clinical trial at EEH BCRT demonstrated significant decreases in the Targeted Chemotherapy Drugs (3) PSA levels of all patients and that the vaccine was well tolerated. Initial congressional funding of $1 million and support from the Naval Health Research Center has allowed NUMBER OF EMPLOYEES: 5 development of methods for PSA protein synthesis and the Phase 1 clinical trial design. In 2009, OncBioMune received a second round of funding of $2.25 Million in congressional funding for completion of PSA protein manufacturing under cGMP and final IND submission. Then In 2010, the company received a third round of funding to fully fund a phase 1a/1b USE OF FUNDS clinical trial that will begin August 2012 and will be hosted by UCSD. The company is Clinical development and currently finishing the administrative requirements to begin the trial. licensing activities. . Priority on Phase I/II for prostate cancer vaccine; MANAGEMENT – OncBioMune is led by two key individuals with extensive experience in patient care, research, and the clinical development of therapies. CEO and Medical Director Phase I and II for breast cancer Robert Elliott, M.D., Ph.D., founded the Elliott-Elliott-Head Breast Cancer Research and vaccine; Treatment Center in 1973 and is considered an expert in diseases of the breast as well as an innovator in cancer therapy and research. President and Director of Research Jonathan Phase I for lead innovative Head, Ph.D. is a prominent tumor cell biologist, specializing in cell culture and human clinical chemotherapy drug. research in immunotherapy and innovative chemotherapy. He has served as the director of research and development for several companies and has led the preclinical and clinical development of the company’s therapies. MARKET OPPORTUNITY – Breast, Prostate and Ovarian cancer represent three of the largest markets for cancer treatment. Breast cancer is the leading cause of cancer among women with an estimated market size of $11.5 Billion by 2011. Prostate cancer is one of the leading cancers among men with a market size of $ 5 Billion expected by 2011. The market for ovarian cancer is also expected to grow substantially to an estimated $ 2.5 Billion by 2011. COMPETITION – Competition for the company’s cancer vaccines and targeted therapies comes from FDA-approved conventional chemotherapy agents and a small number of monoclonal antibodies. Breast cancer vaccines currently in development include ADVEXIN® (Introgen Therapeutics), Phase II clinical trial ongoing; and TROVAX® (Oxford Biomedica), Phase I trial completed. Prostate cancer vaccines in development include PROVENGE® (Dendreon Corporation), FDA approval GVAX® (Cell Genesys), Phase III trial ongoing; and PROSTVAC®-VF (Therion Biologics) Phase II trial ongoing.OncBioMune LLC India Contact: Godwyn Francis th17050 Medical Center Drive, 4 Floor Phone: +91-787-501-6957Baton Rouge, LA 70816 CONFIDENTIAL Email: godwyn@aagami.net
  2. 2. ONCBIOMUNE LLC Technology DescriptionDeveloping Targeted Therapies to Fight Cancer www.oncbiomune.com Targeted Cancer TreatmentsOur Solution / Mechanism of ActionOncbiomune has clinical studies on three targeted chemotherapeutic agents and is in preclinical development of a fourth. Theseagents use our transferrin-based technology to deliver toxic metals and chemotherapeutic agents that interfere with the aberrant ironmetabolism of cancer cells. Cancer cells require high concentrations of iron to carry on cell division and grow. Therefore transferrin,the transporter of iron in the body, can be used to carry toxic heavy metals and chemotherapeutic agents directly into cancer cells.These drugs, used alone or in combination, have demonstrated tremendous cancer cell killing with very little affect on normal cellsand minimal side effects. They have also been shown to potentiate the effect and lessen the toxicity of conventional chemotherapywhen given with it.  CT (Cisplatin Transferrin) – Phase I and II  GT (Gallium Transferrin) – Phase I and II  DGT (Doxorubicin Gallium Transferrin) – Phase I and II  PGT (Paclitaxel Gallium Transferrin) - Preclinical  PA (Paclitaxel Albumin) – PreclinicalIntellectual Property- Patent application has been submitted for PGT and PA.  PGT application: pending in U.S., Canada, and Europe only  Whole-cell vaccine application: Pending internationally and awaiting ex-U.S. filing  PSA vaccine application: pending in U.S. and internationallyHighlights of Previous Preclinical and Clinical StudiesThe transferrin-based technologies are at various levels of development from pre-clinical (paclitaxel gallium transferrin (PGT) andpaclitaxel albumin (PA)) to Phase II trials (cisplatinum-transferrin or CT, gallium-transferrin or GT, and doxorubicin-gallium-transferrin or DGT). PGT is our best candidates for commercial development due to their high cytotoxicity to cancer cells in culture.CT, GT and DGT have each been tested in Phase I and II clinical trials without any major toxicity. In a Phase I/II clinical trial of CT,there was one complete response and three partial responses for an overall response rate of 36% (4 of 11 patients). Multiple, largedoses of the drug were given safely without causing an immune response to the transferrin. This will allow prolonged treatment ofpatients with these drugs. GT and DGT have been tested only in combination with other chemotherapies or in combined chemo-immunotherapy. This makes it hard to quantitate what these two drugs contribute to the overall response to therapy. AdditionalPhase I/II clinical trials by outside investigators are needed.Clinical Development StrategyThe first IND will be filed for PGT (paclitaxel gallium transferrin) for the treatment of advance ovarian cancer. The companybelieves PGT is the strongest of the targeted compounds it has developed.CT, GT, DGT, PGT and PA can be used to treat other cancers. A strategy for completing Phase I and II clinical trials of thesecompounds in other cancers at external institutions will be established as other clinical development milestones are met.Market Opportunity / Clinical NeedBreast cancer represent one of the largest markets for cancer treatment. The U.S. breast cancer treatment market consists of 13drugs approved for use by the FDA. During 2004, just 12 of these drugs contributed to sales of more than $6.2 billion. The13th drug for cancer therapy, Abraxane™, was approved by the FDA in January 2005. Ovarian cancer survival afterchemotherapy of advanced disease is very low and introduction of new drugs for treatment of ovarian cancer will be neededto improve overall survival.Competition / Drugs in DevelopmentSeveral antibodies and small molecules have been described as targeted therapies, but have been found to have greaterthan expected toxicities. On a broad scale, competition for the company’s targeted therapies comes from conventionalchemotherapy agents, which are not specific to tumors and therefore must be dosed at high levels and travel throughout thebody in order to be effective in killing cancer cells.Please contact godwyn@aagami.net or dinesh@aagami.net for more information.OncBioMune LLC India Contact: Godwyn Francis th17050 Medical Center Drive, 4 Floor Phone: +91-787-501-6957Baton Rouge, LA 70816 Email: godwyn@aagami.net