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A Tale of Two (?) IBDs. CYMMBiosis for Cure Colleen Feriod, PhD candidate Yujie Wang, MBA candidate Matthew Fleming, PhD candidate Michael Coggins, PhD Brian Cope, MBA/MEM candidate. Executive Summary. License GTX-001 “ Gastrolux ”. Pass on GTX-002. IBD Landscape. Ulcerative Colitis

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A tale of two ibds

A Tale of Two(?) IBDs

CYMMBiosis for Cure

Colleen Feriod, PhD candidate

Yujie Wang, MBA candidate

Matthew Fleming, PhD candidate

Michael Coggins, PhD

Brian Cope, MBA/MEM candidate


Executive summary
Executive Summary

License GTX-001

“Gastrolux”

Pass on GTX-002


Ibd landscape
IBD Landscape

Ulcerative Colitis

  • Disease mechanism unknown: genetic, environment, pathogenic factors

  • Highest incidence and prevalence in age group 15-30

Crohn’s Disease

Disease mechanism unknown: genetic, environment, pathogenic factors

Highest incidence and prevalence in age group 20-29



Target product profile
Target product profile

Target product profile

GastroluxGTX-002

Criteria

Is it medically plausible?

Is there a penetrable market?

Is this financially viable?

Is it safe?

Does it perform better than SOC?


Pathophysiology of ibd
Pathophysiology of IBD

Crohn’s Disease

Ulcerative Colitis

Unknown (genetic, environment, pathogenic)

Initiation

Visible and invisible symptoms

Immune

response

Diagnosis of severity:

Mild, moderate,

severe

Treatment depends on:

Incident vs. recurrent

Severity of diagnosis

Unknown (genetic, environment, pathogenic)

Initiation11111

Visible and invisible symptoms

Immune 1111

Response1111

Diagnosis of severity:

Mild, moderate,111

severe111

Treatment depends on:

Incident vs. recurrent111

Severity of diagnosis111


Market analysis
Market Analysis

Crohn’s Disease

Ulcerative Colitis

GTX-002

Gastrolux

Competitors


Financial analysis
Financial Analysis

  • NPV most sensitive to changes in discount rate and price growth

  • The breakeven values: discount rate = 13.9%; price = $7,554

  • Expected Value of Average Scenario = $46,793, 384


Critical signals in development
Critical Signals in Development

Pre-Clinical

Phase I

Specifics

-In vitro and in vivo studies

on animal IBD models

-Dosage

-Gastrolux vs. SOC

-Safety assessment

-Single ascending dose and/or

multiple ascending dose studies

-Food effect study

Phase III

Phase II

-IIA: Assess dosing requirements

-IIB: Study drug efficacy

-Gastrolux efficacy vs. SOC

-Submit for approval to FDA

and EMEA

*Efficacy is defined as decrease in symptom severity, increase in time between flares,

reduction in disease severity progression, and/or inducing remission during acute flares


Evaluation

Signal Risks

Reward > Risk?

Medical

Market

Financial

Safety

Improved treatment

Legislative

Long-term surveillance

  • Gastrolux is a viable target product

  • High unmet need

  • High revenue potential

  • Barren competitive landscape

    GTX-002 is not viable

  • Greater market size but higher consumer elasticity

  • Breakeven price exceeds market potential


Biological risk
Biological Risk

Gastrolux

  • Able to safely and effectively block VLA-1 in humans and in appropriate patient subset?

  • Is VLA-1 present on T2 cells allowing UC as viable market?

    GTX-002

  • Able to safely and effectively block NFκB in appropriate T cells only?

    General

  • Recent science suggests T17 cells are a point of convergence for CD and UC.

  • Is VLA-1 present on T17 cells?

  • Can NFκB be targeted in this T cell subset?




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