Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - GENOCEA BIOSCIENCES, INC. | gnca-20160929x991sheddingp.htm |
| 8-K - 8-K - GENOCEA BIOSCIENCES, INC. | gnca-20160929x8k.htm |
Positive Viral Shedding
Efficacy Results
GEN-003 Immunotherapy for
Genital Herpes
Phase 2b Study
September 29, 2016
Exhibit 99.2
This presentation contains “forward-looking” statements that are within the meaning of federal securities laws
and are based on our management’s beliefs and assumptions and on information currently available to
management. Forward-looking statements include information concerning our possible or assumed future
results of operations, business strategies, financing plans, competitive position, industry environment, potential
growth opportunities, potential market opportunities and the effects of competition.
Forward-looking statements include all statements that are not historical facts and can be identified by terms
such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,”
“predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-
looking statements represent our management’s beliefs and assumptions only as of the date of this
presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any
one of which, or combination of which, could materially affect our results of operations and whether the
forward-looking statements ultimately prove to be correct. Factors that may materially affect our results of
operations include, among other things, those listed in our Annual Report on Form 10-K and other filings with the
Securities and Exchange Commission (“SEC”). Except as required by law, we assume no obligation to update
these forward-looking statements publicly, or to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new information becomes available in the future.
You may get copies of our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and our other SEC filings
for free by visiting EDGAR on the SEC website at http://www.sec.gov.
2
Safe Harbor Statement
• 60 µg per protein / 50 µg of Matrix-M2 adjuvant dose hit primary
clinical trial endpoint
– 40% viral shedding rate reduction consistent with prior trial
• Safety profile acceptable
– Low discontinuation rates due to AEs; distributed across dose
groups, including placebo
– No grade 4 reactogenicity or related AEs
• GEN-003 on track for 2H 2017 Phase 3 start
– Phase 2b 6 month clinical efficacy data expected: January 2017
– FDA end of Phase 2 meeting expected: Q1 2017
– Phase 2 antiviral combination study start expected: Q4 2016
3
Highlights
• Market potential for GEN-003
• Phase 2b trial
– Study design
– Top line data
• Physician perspective – Lori A. Panther, MD, MPH
• Important 2017 clinical and regulatory milestones
• Conclusions
• Q&A
4
Agenda for Today’s Call
• Genital herpes characterized by viral shedding, leading to
disease transmission and genital lesions
• Oral antiviral therapy insufficient for millions
– Viral shedding reduced only when patients are taking medication
but most use episodically
– Lesions still occur even on chronic therapy
• GEN-003 designed using ATLAS to direct T and B cells to fight
clinical disease by reducing viral activity
• GEN-003 product profile drives revenue opportunity of >$1bn in
U.S. alone*
5
The Need for New Genital Herpes Treatments Drives
Large Market Opportunity
*Based on Genocea-sponsored market research
• Overall goal
– Select dose of Phase 3-ready formulation of GEN-003 for Phase 3
trials
• Primary endpoint
– Compare efficacy versus baseline of two dose levels of GEN-003
and placebo by impact on viral shedding
• Secondary objectives
– Evaluate impact on clinical disease versus placebo at 6 and 12
months(a)
• Proportion recurrence free
• Time to next recurrence
• Lesion rates
– Safety and tolerability
– Immunogenicity(a)
6
Phase 2b Trial Goals and Objectives
(a) Not part of top-line read-out
• Randomized, double-blind, placebo-controlled
• 131 subjects with a history of recurrent genital herpes
• 3 dose groups, followed for 12 months
– Placebo (n=44)
– 60 µg per protein / 50 µg of Matrix-M2 (n=43)
– 60 µg per protein / 75 µg of Matrix-M2 (n=44)
• Consistent with prior trials
– Inclusion / exclusion criteria, demographics, sites, dose regimen,
endpoints, observation periods, swabbing compliance
7
Study Design
6%
-40%
-27%
-50%
-40%
-30%
-20%
-10%
0%
10%
Placebo 60/50 µg 60/75 µg
R
e
d
u
c
ti
o
n
in
V
ira
l S
h
e
d
d
in
g
R
a
te
v
s.
B
a
se
lin
e
• In prior Phase 2, this antiviral
efficacy increased to 66% at
12 months; led to significant
and durable clinical efficacy
at 6 & 12 months
• 60 / 75 µg dose showed a
27% reduction vs. baseline
(not significant)
• Robust control arm in
placebo group
8
Statistically Significant 40% Viral Shedding Rate
Reduction for 60 / 50 µg Dose
Viral Shedding Rate Reduction by Dose Group
*Poisson model analysis (refined since prior Phase 2 trial with reference to advances in the field:
Magaret, Amalia, "Models for HSV shedding must account for two levels of overdispersion"
(January 2016). UW Biostatistics Working Paper Series. Working Paper 410.
http://biostats.bepress.com/uwbiostat/paper410)
p-values*
vs. baseline 0.03
vs. placebo 0.05
• Safety continuously reviewed by Independent Data Safety
Monitoring Board
• Low discontinuation rate due to AEs; similarly distributed across
dose groups including placebo
• Reactogenicity consistent between 2 trials for 60 µg /50 µg dose
• No grade 4 reactogenicity or related SAEs in either this trial or
prior Phase 2 trial
9
Overall Summary of Safety
Lori A. Panther, MD, MPH
Infectious Diseases specialist at Beth Israel
Deaconess Medical Center and Assistant Professor
of Medicine at Harvard Medical School
GEN-003 Physician
Perspective
10
11
Potential H2 2017 Phase 3 Start for GEN-003 On Track
2016 2017
6 month
6 month
clinical 12 month
FDA EoP2
Phase 2b
Phase 2b
Antiviral
Combination
Phase 3
Regulatory
• Confirm robust
efficacy with
Phase 3
material
• Confirm
Phase 3
program
• Explore
potential
additive effect
• Virologic efficacy profile of Phase 3-ready GEN-003 formulation
confirmed for 60 / 50 µg dose ahead of Phase 3
• GEN-003 safety profile appears acceptable
• 60 / 50 µg dose selected for subsequent trials
– Phase 2b antiviral combination study start expected in Q4
– Potential Phase 3 start in second half of 2017 on track
• 6 month Phase 2b clinical efficacy data expected January 2017
– In prior trial, virologic efficacy post dose 3 translated into significant
and durable clinical efficacy, at 6 and 12 month time points
12
Conclusions
Questions & Answers
13
Liz Bryan
Spectrum Science
Communications
Phone: +1 202-587-2526
lbryan@spectrumscience.com
Investor inquiries: Media inquiries:
Jonathan Poole
Chief Financial Officer
Phone: +1 617-876-8191
jonathan.poole@genocea.com