Dyadic International, Inc. · NASDAQ:DYAI

Dyadic International — Technical Presentation (September 2015)

15 slides from Dyadic International's technical presentation, Sep 14, 2015

  1. Slide 1: C1 rHA-TMD from Dyadic: Immunogenicity study in mice

    C1 rHA-TMD from Dyadic Immunogenicity study in mice Test MLE-PT-RFA-15002-Ms Mise à jour du 14 sept 2015 CONFIDENTIAL | 1

  2. Slide 2: Three questions

    Three questions 1. Does the rHA-TMD induced clinical signs in mice? 2. Is the C1 rHA-TMD immunogenic and how does it performed compared to the baculo-rHA? 3. Is there an adjuvant effect due to the C1 matrix at high dose? CONFIDENTIAL | 2

  3. Slide 3: Tested Products and characterization

    Evaluation of C1 rHA-TMD from Dyadic Tested Products and characterization Test MLE-PT-RFA-15002-Ms Denomination Batch Number Protein content / HA content Endotoxin Purity (IU/mL –BRD) Recombinant HA from the 1869 BCA (sp): 791 µg/mL 12 A/H1N1/New µBradford (sp): 627 µg/mL 80% Caledonia/20/99 strain

  4. Slide 4: Biochemical characterization of the two rHAs

    Evaluation of C1 rHA-TMD from Dyadic Biochemical characterization of the two rHAs Test MLE-PT-RFA-15002-Ms 1 2 Similar oligomeric state between both rHAs 1 2 HA SDS-PAGE TEM Negative staining Native PAGE 1 C1 rHA TMD 1869 2 Baculovirus rHA PS lot 1367-057 1 N-glycosylation profile of HA by mass spec

  5. Slide 5: Immunogenicity evaluation of rHA Dyadic (88 mice): Study design

    Immunogenicity evaluation of rHA Dyadic (88 mice) Study design - Test MLE-PT-RFA-15002-Ms ● Balb/C ByJ mice - 9 weeks-old - 2 IM immunizations (D0 & D28) under IM 100µl (50µl /thigh): total 88 mice immunizations ● Products D0 D27 D28 D49  3-Fold Escalating doses of Protein Sciences-rHA : 1 - 3.33 -

  6. Slide 6: Question 1: Does the rHA-TMD induce clinical signs in mice?

    Question1: Does the rHA- TMD induced clinical signs in in mice? CONFIDENTIAL | 6

  7. Slide 7: Clinical follow-up results

    Clinical follow-up results- Test MLE-PT-RFA-15002-Ms ● No weight loss (as per weigh measurement between D0 and D28) ● No clinical signs effect during the all experiment (visual observations every day) CONFIDENTIAL | 7

  8. Slide 8: Question 2: Is the C1 rHA-TMD immunogenic compared to baculo-rHA?

    Question 2: is the C1 rHA- TMD immunogenic and how does it performed compared to the baculo-rHA? CONFIDENTIAL | 8

  9. Slide 9: HI titer against A/New Caledonia/20/99 (H1N1): post-1 IM (D27)

    Immunogenicity evaluation of C1 rHA-TMD Results: A/NC/20/99 HI specific response post-1 IM (D27) LE-PT-RFA-15002-Ms - HI against A/New Caledonia/20/99 (H1N1) results - Post-1 IM (D27) A/New Caledonia/20/99 (H1N1) rHA-TMD rHA Baculovirus Negative Controls HI response after 1 IM immunization in Myceli

  10. Slide 10: HI titer against A/New Caledonia/20/99 (H1N1): post-2 IM (D49)

    Immunogenicity evaluation of C1 rHA-TMD Results: A/NC/20/99 HI specific response post-2 IM (D49) -RFA-15002-Ms - HISignificant difference against A/New : Caledonia/20/99 (H1N1) results - Post-2 IM (D49) C1-rHA >baculo-rHA A/New Caledonia/20/99 (H1N1) rHA-TMD rHA Baculovirus Negative Controls Mycelio

  11. Slide 11: Question 3: Is there an adjuvant effect due to the C1 matrix at high dose?

    Question 3: is there an adjuvant-effect due to the C1 matrix at high dose? ●CONFIDENTIAL | 11

  12. Slide 12: Matrix effect at high dose: post-1 IM (D27)

    Evaluation of the matrix effet of C1 rHA-TMD at high dose Results: A/NC/20/99 HI specific response post-1 IM (D27) Not MLE-PT-RFA-15002-Ms - HI against statistically A/New analyzed Caledonia/20/99 (H1N1) results - Post-1 IM (D27) A/New Caledonia/20/99 (H1N1) baculo-rHA Spiked groups Negative Control

  13. Slide 13: Matrix effect at high dose: post-2 IM (D49)

    Evaluation of the matrix effet of C1 rHA-TMD at high dose Results: A/NC/20/99 HI specific response post-2 IM (D49) Significant difference : Adjuvant-effect with both C1-mock preparations LE-PT-RFA-15002-Ms - HI against A/New Caledonia/20/99 (H1N1) results - Post-2 IM (D49) Mock2 most representative

  14. Slide 14: Conclusions

    Conclusions 1. The full length recombinant HA from the A/H1N1/New Caledonia/20/99 strain produced in Myceliophthora thermophila (C1 fungi) did not induce any clinical signs in mice 2. The full length recombinant HA from the A/H1N1/New Caledonia/20/99 strain produced in Myceliophthora thermophila (Dy

  15. Slide 15: Next steps

    Next steps ● To confirm those results with other influenza vaccine strains CONFIDENTIAL | 15

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