“Delivering the Promise of Genetic Medicine and Vaccines”
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“Delivering the Promise of Genetic Medicine and Vaccines”. NAPWA Symposium 6 th IAS Meeting An HIV-based Lentiviral Vector Vaccine Achieves Functional Cure Post-challenge in a Subset of Vaccinated Macaques Dr. Lawrence Michaelis Chairman and CEO Rome, July 19 th 2011. 1.

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NAPWA Symposium 6 th IAS Meeting

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Napwa symposium 6 th ias meeting

“Delivering the Promise of Genetic Medicine and Vaccines”

NAPWA Symposium

6th IAS Meeting

An HIV-based Lentiviral Vector Vaccine Achieves Functional Cure Post-challenge in a Subset of Vaccinated Macaques

Dr. Lawrence Michaelis

Chairman and CEO

Rome, July 19th 2011

1


Vrx496 autologous cd4 t cell therapy

VRX496 Autologous CD4 T Cell Therapy

65 patients in several Phase 1 and 2 trials of VRX496

Infusions found to be safe

Induces significant CD4 cell increases in a sub-set of HIV-infected patients. Decreased viral load set point in STI setting.

Produces mutations in HIV, making the virus less fit to replicate (see IAS WEPDA0205 Poster Discussion)

Decision made to secure funding to advance program to Phase 2b

ACTG agreed to support next trial

Search for corporate co-development partner

VRX496 platform provided important insights into next generation product - HIV vaccine candidate, VRX1273

Safety

Design

Manufacturing

2


General benefits of therapeutic hiv vaccine

General Benefits of Therapeutic HIV Vaccine

Lower viral load

Lower forward transmission

Preserves the CD4 compartments

Extends survival

No toxicities

Low frequency of treatment

Preserve ARV alternatives

Significantly reduce cost

3


Benefits of therapeutic hiv vaccine

Benefits of Therapeutic HIV Vaccine

General Benefits

Lower viral load

Lower forward transmission

Preserves the CD4 compartments

Extends survival

No toxicities

Low frequency of treatment

Preserve ARV alternatives

Significantly reduce cost

  • VIRxSYS’ VRX1273

    • Viral load reduction achieved

    • CD4 compartments maintained

    • Survival advantage demonstrated

    • No toxicities and reinfusion-safe

    • Single set of infusions effective

    • No drug-resistance of HIV expected

    • Anticipated to be cost effective

    • Clade-agnostic. Designed for global application

4


Benefits of therapeutic hiv vaccine1

Benefits of Therapeutic HIV Vaccine

General Benefits

Lower viral load

Lower forward transmission

Preserves the CD4 compartments

Extends survival

No toxicities

Low frequency of treatment

Preserve ARV alternatives

Significantly reduce cost

  • VIRxSYS’ VRX1273

    • Viral load reduction achieved

    • CD4 compartments maintained

    • Survival advantage demonstrated

    • No toxicities and reinfusion-safe

    • Single set of infusions effective

    • No drug-resistance of HIV expected

    • Anticipated to be cost effective

    • Clade-agnostic. Designed for global application

VRX1273 HIV Vaccine – Targeted as a Functional Cure

5


Napwa symposium 6 th ias meeting

* T.C. Friedrich and D.I. Watkins, 2005

Objectives for VIRxSYS’ VRX1273 HIV Vaccine

  • Reduce viral load

  • Preserve the CD4 compartments

  • Extend survival

6


Napwa symposium 6 th ias meeting

Outstanding Results from the NHP SIV Model

  • Vaccine extremely immunogenic

    • Unique, high-magnitude CD8 responses to SIV

  • Strong protection from extremely high and pathogenic challenge; 40% of vaccinated monkeys responded favorably:

    • Long-term control of viral load, over a 18-months period, down to undetectable levels

    • Complete preservation of the immune compartment: vaccinees are not immuno-deficient and develop no symptoms of AIDS

    • SIV control extends to the immune sanctuaries, with dramatic decrease of virus in all reservoirs tested

    • Improved survival in all vaccinees, even in those that did not truly “respond” according to the above parameters

* Please refer to Late-Breaker abstract MOLBPE042: Franck Lemiale et al. “A lentiviral vector HIV vaccine candidate protects macaques from high dose SIV intrarectal challenge: vaccine responders achieve functional cure”.

7


Napwa symposium 6 th ias meeting

Proviral DNA in lymph nodes

Proviral DNA in jejunum

Proviral DNA in PBMC

Plasma viral load

SIV DNA copies/million cells

SIV RNA copies/ml

SIV-infected, deceased

Unvaccinated EC

LV-vaccinated

SIV-infected, deceased

Unvaccinated EC

LV-vaccinated

1.E+04

1.E+03

SIV DNA copies/million cells

SIV DNA copies/million cells

1.E+02

1.E+01

SIV-infected, deceased

SIV-infected, deceased

Unvaccinated EC

LV-vaccinated

Unvaccinated EC

LV-vaccinated

Reduced SIV Provirus in Reservoirs of Vaccinees

LV-only vaccine responders

Averages of 13 NHP deceased of SIVmac251 infection

Mamu B*08+/B*17+ Elite Controller (EC)


Napwa symposium 6 th ias meeting

Next Steps

  • HIV Vaccine Program was presented to the FDA

    • Pre-IND meeting successfully completed

      • No challenge to the strategy of using integrating HIV-based lentiviral vector as vaccine

  • Finalized clinical design with help of Medical Advisory Board

  • Preparing for IND-enabling studies (Tox/Biodistribution), analytical assays development and manufacturing scale-up

9


Napwa symposium 6 th ias meeting

Why so Little for Therapeutic Vaccines?

  • As for today, no preventive vaccine approach succeeded

    • Despites over 20 years of efforts and massive investments

    • Furthermore, preventive vaccine does not address the growing needs of alternative treatments for HIV infected individuals

    • Thus one may question why there are insufficient funds available to develop therapeutic vaccine aimed at functional cure

  • Small companies cannot do everything themselves

    • Focusing on product development is their mandate

    • Advocacy groups are better suited pushing a change in priorities

We need your support for developing a

Functional Cure for HIV

10


Napwa symposium 6 th ias meeting

“Delivering the Promise of Genetic Medicine and Vaccines”

Thank You

11


Napwa symposium 6 th ias meeting

First ; Advantages of a TV

Second: Overview of the monkey study. Emphasize toxicity and all animals severely infected, no prime, etc.

Third: Results at 6, 12, and 18 months : VL, Survival, immune System, Proviral DNA, and lymphactics

Fourth: Review our interpretation. “Not aware of other primate studies with such results, comments from MAB, what we would have with 40%, lentiviral vector and safety, PV in a therapeutic setting.

Five: Next steps, FDA, Plan on TI in Phase I, More attention for funding of Functional cures,


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