1 / 15

FIT Biotech Ltd.

“ The therapeutic effect of FIT-06, GTU®-Multi-HIVB DNA vaccine, observed in HIV-1 infected people . R esults of a Phase II trial”. . FIT Biotech Ltd. Private Company, founded in 1995 Based in Tampere, Finland cGMP manufacturing facility

calder
Download Presentation

FIT Biotech Ltd.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. “The therapeutic effect of FIT-06, GTU®-Multi-HIVB DNA vaccine, observed in HIV-1 infected people.Results of a Phase II trial” .

  2. FIT Biotech Ltd. • Private Company, founded in 1995 • Based in Tampere, Finland • cGMP manufacturing facility • GTU® - Gene Transport Unit - Proprietary vector platform technology • Solid IP covering GTU® globally

  3. Novel DNA plasmid based GTU® Vector Properties • Safe • Non-replicating, non-integrating DNA plasmid • Multiple injections possible • Effective • Episomal anchoring and segregation-partitioning enhancement • Higher # cells transfected, and high expression level of gene of interest • Solid IP position

  4. GTU Enhances Expression in Muscle and SkinIn Vivo

  5. Preclinical Studies with GTU® Vectors • Expression studies • Superior expression of antigen in GTU versus conventional vectors - comparative data from mice, swine and non-human primates • Lower amount of DNA needed • Preclinical immunogenicity studies in non-human primates (Martinon et.al., 2009, Human Gene Therapy)

  6. Primate Data: Antigen Expression in Draining Lymph Nodes p24 + CD1a Day 8 post injection MultiHIVi.d. + EP • Macaque study published 2009 in Human Gene Therapy • Plasmid delivered intradermally into keratinocytes • Found antigen in draining lymph nodes • This is evidence of cross-presentation

  7. Conclusions from NHPStudies 7 • AuxoGTU ®-MultiHIV B plasmid induces strong anti-HIV cell-mediated immune response • Induces polyfunctional (IFNg + IL-2)T-cells • Induces long lasting HIV specific T-cells (> 3 years) • The response is strongly dependent on the delivery method

  8. Therapeutic HIV Vaccine for Functional Cure • Immunological support for HIV infected individuals • Lowers plasma viral load • Reduces sexual and mother-to-child transmission • Restores functional CD4 cells • Delays development of AIDS • Early therapeutic intervention in HIV infected individuals • Reduces side effects caused by ART • Reduces drug induced resistant mutations

  9. GTU®MultiHIV Vaccine: Six Target Genes • A fusion protein representing 6 different HIV-1 genes • The antigen sequences are derived either from the specific isolate or are deduced from the HIV1 consensus (A, B, C) and phylogenetic ancester (FGH) sequences • Maximal representation by in tandem arrayed epitope-rich regions • Codon optimization for maximal expression and inclusion of immuno-stimulatory sequences • Preclinical studies - mice,swine, NHP

  10. EPITOPES NEF GAG REV TAT FIT Biotech’s Novel Therapeutic HIV Vaccine (GTU-MultiHIV-B) CMV 10 E2 BS • GTU DNA technology is unique because it allows: • Long-term expression of gene of interest • Less DNA needed per immunisation • E2 BPV segregation/partitioning function MultiHIV-B GTU-MultiHIV-B 8803 bps BPV1 E2 RSV LTR 10

  11. Randomized Placebo-Controlled Phase IIa Trial N=20 IM N=20 ID N=10 IM N=10 ID 108 Final evaluation Weeks -4 0 1 4 5 12 13 16 40 64 76 80 84 88 • Primary endpoints: safety & immunogenicity • Secondary endpoints: pVL, CD4 cell counts • Enrollment characteristics: • Age 29 yrs (range: 18-40 yrs). • - Plasma viral load > 38000 copies/ml • CD4 cells/ µl > 500 • C clade infected • Treatment-naive South Africans Treatment-naive FIT-06 IM (1mg), ID (0.5 mg) FIT-06 IM (2mg), ID(1mg) Placebo IM & ID

  12. HIV-Specific CD4 and CD8 T-CellResponsesIncreaseFollowing Vaccination P = 0.010 P = 0.0014 % of Ag specific CD8 T cells % of Ag specific CD4 T cells • Additional Relevant Data: • Responses to Gag-B and/or Gag-C at V11 (week 76) and/or V13 (week 84) were observed: • - CD4 response observed in 83% of participants • - CD8 response observed in 67% of participants • CD4 and CD8 response observed in 55% of participants • An increase of antigen-specific CD4 and CD8 T cells secreting TNFα was observed

  13. Average Changes in Plasma Viral Load and CD4 Cell Counts after 108 Weeks AverageChange in Plasma ViralLoad(after 108 weeks) AverageChange in CD4 CellCounts(after 108 weeks) ID=Intradermal IM=Intramuscular 13

  14. Change from Baseline in Viral Load for Patients with Viral Load ≤4.5 at Baseline Confidential

  15. Key Clinical Results • FIT Biotech GTU DNA vaccine is safe and well tolerated in HIV infected individuals • FIT Biotech has demonstrated clinically relevant effects on the two major markers of functional cure • GTU DNA vaccine favourably increases CD4 cell counts in untreated, chronically infected individuals • When compared to placebo, IM immunization had a significant impact on decreasing pVL for at least 27 months of study follow up • Enhanced effect on pVL in subjects with favorable HLA allele type [B*5703] • The results obtained are with a B-Han-2 isolate clade vaccine

More Related