Homspera march2010

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Transcript of Homspera march2010

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2. Safe Harbor & Data Presented Statements about the Company's future expectations, including statements about the potential use and scientific results for the Company's drug candidates, science and technology, and all other statements in this presentation other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. The Company's actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in the Company's periodic report on Form 10-Q for the three months ended September 30, 2009 as filed with the Securities and Exchange Commission and report on Form 10-K for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. There are no guarantees that any of the Company's proposed products will prove to be commercially successful. The Company undertakes no duty to update forward-looking statements. Data presented in this presentation may not be comprehensive; please contact ImmuneRegen for additional information. 3. Mission We are a biotechnology company, focused on advancing products that regenerate or strengthen the human immune system, in part, through stimulation of adult stem cells. We are working to capitalize on our drug candidates by continuing our own development programs and simultaneously seeking to license product use for specific indications to Industry partners. To be recognized for developing safe and effective therapeutics and for driving value through drug development programs that attract licensing and collaborative partnerships. 4. Pipeline 5. Idiopathic Pulmonary Fibrosis Influenza Therapeutic Cancer Therapeutic Vaccine Adjuvant Biological and Chemical Agents Radiation Damage (Neutropenia) Wound Healing Oral Administration

  • Solid dosage form providescompounding flexibility
  • No additional devices needed for administration
  • Ships formulated for maximum stability, no liquid additions
  • Solid may preclude need for cold chain
  • May enable remote stockpiling
  • May provide environment-insensitive stability

Oral Bioavailability Study shows oral or intra-duodenal Homspera administration results inmeasurable and pharmacologically relevant plasma and pulmonary drug concentrations. Indications Oral administration Potential Benefits ofOral Administration 6. (ArgProLysProGlnGlnPhePheSar LeuMet(O 2 ) -NH 2 ) Homspera vs. Substance P Homspera NK-1 Receptor Specific Homspera NK-1R (neurokinin-1 receptor) Substance P NK-1R NK-3R NK-2R (ArgProLysProGlnGlnPhePheGly LeuMet -NH 2 ) 7. Alberts, B. et al. (2002) Molecular Biology of the Cell (4 thed.);Koon, H. et al. (2007)PNAS.104:2013-2018; Koon, H. et al. (2006)J Immunology.176:5050-5059; Yang, C et al. (2002)Cellular Signaling.14:913-923;Koon, H. et al. (2005)J Pharmacology & Experimental Therapeutics.314:1393-1400.Mechanism of Action Homspera 8. Homspera - Resistant to enzymatic degradation Homspera vs. Substance P Homspera modifications Arg Pro Lys Pro Gln Gln Phe Phe Gly Leu Met NH 2 1 2 3 4 5 6 7 8 9 10 11 Dipeptidyl peptidase IV Angiotensin converting enzyme Neprilysin Substance P endopeptidaseEndothelin-converting enzyme - 1 Prolyl endopeptidase(E.C. 3.5.4.4) (E.C. 3.4.21.26) (E.C. 3.4.24.11) (E.C. 3.4.15.1) (E.C. 3.4.24.71) 9. Roosterman D et al. PNAS 2007;104:11838-11843 ECE-1 regulates NK1 recycling Homspera Resistant to ECE-1 degradation 10. NK1-R links to MAPK and ERK1/2 (1) SP binding to the NK1R leads to recruitment of -arrestin to the receptor, assembly of a MAPK signalosome, and ERK1/2 activation.(2) Degradation of SP by ECE-1 in acidified endosomes disrupts the SP/NK1R/arr/MAPK signalosome.(3) NK1R recycles to the plasma membrane for resensitization.(4) Inhibiting ECE-1 activity causes sustained ERK1/2 activation and SP-induced cell death. From Murphy JE, Padilla BE, Hasdemira B, Cottrell GS and Bunnett NW (2009) PNAS 106(42) 17615-17622 Endosomal ECE-1 regulates SP-induced ERK activation and cell death NK1-R internalization coupled to beta-arrestin scaffolding triggers kinase cascade. Substance P degradation recycles receptor/terminates signal. Homspera resistance to ECE-1 alters intracellular signal for discordant membrane / intra-cellular signals (published by others) 11. Mechanism of Action Summary of Underlying NK1-R Mechanisms

  • Increased hematopoietic progenitor cells from both the myeloid and lymphoid lineages
  • Direct stimulation of immune cells including macrophages and neutrophils AND antigen presenting cells
  • Augmentation of the innate immune response dependent upon the status of the local microenvironment
  • Direct stimulation of dermal fibroblasts, keratinocytes and epidermal cells
  • Distinct antagonist and intracellular activity profiles compared to SP

12. Image adapted from http://www.isscr.org/public/images/blood_fig_sm.jpg Cell Differentiation Primitive Stem Cell Specialized Cells Hematopoietic Stem Cell CFU-GEMM Common Lymphoid Progenitor Common Myeloid Progenitor Granulocytes Megakaryocyte Erythrocyte CFU-GM Platelets NK cell T cell B cell Macrophage Monocyte Adult Hematopoietic Stem Cells (HSCs) 13. Data collected by ImmuneRegen under contract with HemoGenix HSCs -Homspera stimulates progenitors Methodology: Colony forming assays were performed under both optimal and sub-optimal cytokine/growth factor conditions.The sub-optimal conditions were 1/50th the concentration of those considered optimal and were concentrations known to support stem cell growth and differentiation.Culturing the cells under sub-optimal growth conditions is an important control often used to examine a compounds stimulatory effect on HSCs.If the cells in culture are already maximally stimulated (as they could be under optimal conditions), there is a reduced chance of detecting a compounds stimulatory activity.Likewise, if an experimental compound merely substitutes for a deficient growth factor, it would only be effective under sub-optimal conditions. Therefore, it is useful to compare results under both conditions. 14. Data collected by ImmuneRegen under contract with University of Medicine and Dentistry of New Jersey Colony forming assays were performed under optimal cytokine/growth factor conditions.HSCs -Homspera stimulates progenitors 15.

  • Increases stem cell differentiation into cells that are required to regenerate or strengthen the human immune system
  • Enhances production of the following precursors:
    • White blood cells
        • Granulocytes
        • Macrophages
        • T cells
        • B cells
    • Platelets
    • Red blood cells

Data collected by ImmuneRegen under contract with the University of Medicine and Dentistry, New Jersey (UMDNJ) and HemoGenix Adult Hematopoietic Stem Cells Homspera Summary of effects 16. Radiation & Neutropenia Homspera Findings

  • Increased survival of small animals exposed to lethal radiation levels
  • Treatment is more effectiveafterexposure to radiation
  • WBC numbers increase in treated animals
  • Data suggest Homspera could resolve the neutropenia often associated with chemotherapy drugs

Radiation studies performed by TD2 (dose-rate study and pre vs. post-exposure efficacy) and University of Arizona (survival) 17. Performed at the University of Arizona Radiation -Homspera findings Homspera promotes survival of lethally-irradiated animals Methodology: Sixteen male C57BL/6 mice (N=8 Homspera-treated and N=8 radiation-only controls) were given a single 7.75 Gy whole body dose of gamma radiation.The control group was administered saline daily via nebulizer for 15 min/day with treatment beginning within 2 hours of radiation exposure. The treatment group was administered Homspera, 50 M solution, 15 min/day under the same conditions.Irradiated + Homspera Irradiated Control 18. Performed by TD2 Radiation -Homspera findings Homspera increases WBC counts following radiation Methodology: 72 Balb/c mice of age 5-6 weeks and normal physiological state (Taconic) were separated into 4 groups: Non-irradiated control (n=12), Irradiated control (n=20), Irradiated / Treated pre-exposure (n=20), and Irradiated / Treated post-exposure (n=20). On Day 1, animals were placed into the X-ray irradiator (RadSource 2000) for 4 minutes.Non-irradiated controls received no radiation exposure while the irradiated contro