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Immune Response BioPharma, Inc. TM            Copyright (c) 2010-2017 

Zorcell TM  Psoriasis Vaccine: 


01/17/2014 U.S. Non Provisional Patent Application Filing #14157548 
                   TCR Peptides Vaccination & Methods Against Psoriasis & Eczema
Zorcell TM: IR-502 Psoriasis Vaccine 

                                                                                           
Psoriasis is a T cell-mediated autoimmune disease of the skin in which the pathology is complex but
clearly involves activated T lymphocytes. The chronological steps in lymphocyte activation leading to the
development of the psoriatic lesion are thought to include initial systemic activation and induction of
specific CD4+ T cells, with infiltration and local accumulation of these specific CD4+ T cells in the skin,
followed by recruitment of non-specific CD4+ lymphocytes and monocytes, and finally clonal
intra-epidermal expansions of CD8+ lymphocytes. There are several compelling lines of evidence for T cell
involvement in psoriasis, including the initiation of psoriatic lesions in immunodeficient mice after transfer
of superantigen or IL-2 activated peripheral blood leukocytes from psoriasis patients. In addition,
intra-epidermal CD8+ T cells isolated from plaque regions were found to be oligoclonal, expressing BV3
and BV13S1 genes in their TCRs. Finally, early stage elimination of activated T cells using IL-2 fusion
toxin has therapeutic benefit.

Zorcell TM Psoriasis Phase II Vaccine Multicenter Study Double Blind Placebo and Adjuvant-Controlled
Trial of TCR Peptide Vaccination in Psoriasis Vulgaris
 Using a Combination of BV3 and BV13S1 20 mer or 40 mer
 CDR2 peptides (Gottlieb et al. in Preparation)
Study Design
 -Treatment regimen
 84 Psoriasis patients, BV3 and BV13S1 CDR2 20 mer or 40 mer
 peptides
 100 mg (50 mg each) peptide/IFA, peptide/Detox ™PC, or
 peptide/Saline, or vehicles alone
 Three i.m. injections (weeks 0, 4, 8)
 -Monitoring over 16 weeks
 T cell proliferation responses and antibodies to each peptide
 Delayed type hypersensitivity (DTH) responses to peptides
 Clinical grading of lesions and Psoriasis Area and Severity
 Index (PASI)

Study Results
 -Safety
 Higher number of adverse events in Detox ™PC and Saline
 groups versus IFA group
 Overall, TCR peptide immunization appeared to be safe and
 well tolerated
 -Immunological responses
 Increased proliferation responses to peptides in both
 peptide/adjuvant treatment groups
 Immunogenicity of 40 mers/adjuvants . 20 mers/adjuvants .
 adjuvants or peptides/saline
Page 1/3PR Log - Global Press Release Distribution
 DTH responses to peptides sporadic but not different among
 groups
 No antibody responses to peptides
 -Clinical responses
 Clinically meaningful PASI changes in IFA group (40 mer,
 28%; 20 mer, 17%; IFA, 7%)
 No clinically meaningful changes in Detox ™PC or Saline
 groups
 No significant difference in target lesion score improvement in
 any treatment group

Conclusions
 -Maximal clinical effects (25% reduction of PASI scores) observed
 with 40 mers in IFA within 4 weeks of peptide booster injection
 -Immunological response to peptide/IFA related to 20% PASI
 changes (40 mer 5 20 mer . controls)
 -Peptides in Detox ™PC showed higher rates of adverse
 reactions, were less immunogenic and yielded lower clinical
 benefits (PASI)
 -Peptides in saline weakly immunogenic with positive clinical trend

Conclusions & Discussion of Results:
 Patients injected with 20 mer or 40 mer peptides in IFA had measurable but sporadic T cell proliferation
responses to peptide,with the 40 mers appearing to be somewhat more immunogenic than the 20 mers.
Peptides in saline were less immunogenic. Overall, significant immunological responses to peptide in either
adjuvant were related to a 20% decrease in the psoriasis area and severity index (PASI). Overall, these early
studies suggest a modest clinical effect of TCR peptide vaccination in psoriasis.These results are not too
surprising given the current knowledge we now have on lymphocyte activation and the relatively late
appearance of targeted CD8+ T cells in the psoriatic lesions, down-regulation of the specific early activated
CD4+ and CD8+ T cells in the lesions may be possible using TCR peptide vaccines. Utilizing
 available agents that have broader but transient effects on PASI scores, such as anti-LFA antibody,
followed by vaccination with TCR peptides to retard formation of new lesions and delay time to flare.





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