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Smallpox vaccine in combination with ST-246

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Smallpox vaccine in combination with ST-246. Robert Jordan, Ph.D. SIGA Technologies, Inc. FDA – Public Hearing May 17, 2007. Sentinel Case. Exposure. Rash……………Death. Fever. Incubation. ~ 14 days. ~ 21 days. ~ 3 days. ACAM-2000. MVA. ST-246. Golden Hours. ST-246.

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slide1

Smallpox vaccine in combination with ST-246

Robert Jordan, Ph.D.

SIGA Technologies, Inc

FDA – Public Hearing May 17, 2007

smallpox deployment scenario

Sentinel

Case

Exposure

Rash……………Death

Fever

Incubation

~ 14 days

~ 21 days

~ 3 days

ACAM-2000

MVA

ST-246

Golden Hours

ST-246

Smallpox Deployment Scenario
slide3

ST-246 Progress to Date

  • ST-246 is a potent, non-toxic and specific inhibitor of

orthopoxvirus replication

  • ST-246 is effective in multiple rodent challenge models against

orthopoxvirus induced pathogenesis and/or disease

  • ST-246 is effective against monkeypox and variola virus in a non-human

primate model of orthopoxvirus disease

  • ST-246 is orally bioavailable with excellent PK parameters
  • ST-246 IND approved, Fast-Track status granted
  • Orphan Drug Designation for prevention and

treatment of smallpox approved

  • Human clinical studies with ST-246 are underway

ST-246

slide4

Cell-to-Cell Spread

Local Infection

Systemic Spread

Disease

ST-246Target is F13L

No Disease*

Replication

&

Assembly

ST-246

F13L

Immature

Virus

(IV)

Intracellular

Mature Virus

(IMV)

Extracellular

Enveloped Virus

(EEV)

TGN

PM

*Animals infected in presence of ST-246 develop a protective immune response

slide5

I.N. vaccinia virus challenge in mice

Dose optimization

No drug

ST-246

animal efficacy highlights
Animal Efficacy Highlights
  • ST-246 protects animals from all orthopoxvirus pathogens tested (VV, CPX, ECTV, RPV, MPX, VaV)
  • Addition of ST-246 up to 72h post infection protects animals from disease & death
  • ST-246 reduces viral replication in lung by 6 logs
  • ST-246 treatment in combination with Dryvax elicits a protective immune response.
slide7

Uses for the ST-246 Smallpox Antiviral

  • Prophylaxis - Prevent disease in non-vaccinated individuals
  • Post-exposure Prophylaxis - Treat non-symptomatic individuals previously exposed to smallpox
  • Therapeutic – Treat individuals exhibiting smallpox disease symptoms
  • Adjunct to Vaccination
    • Use in combination with vaccines to prevent smallpox disease
    • Prevent vaccine-related complications
    • Prevent disease in those populations unable to be vaccinated
cytokine release assay
Cytokine Release Assay

Acute Response

Memory Response

anti vaccinia igg
Anti-Vaccinia IgG

Acute Response

Memory Response

st 246 dryvax conclusions
ST-246/Dryvax Conclusions
  • Vaccine/ST-246 combination elicits enhanced IFN-gamma responses (primarily attributable to CD8 T cells) at both acute and memory phases of the immune response
  • Vaccine/ST-246 combination elicits equivalent proliferative and humoral responses
  • Vaccine/ST-246 combination elicits equivalent protective immunity
  • ST-246 in combination with a smallpox vaccine could protect individuals from severe disease prior to development of protective immunity