Buffalo Biolabs (BBL) is a science-intensive Biotech company conducting preclinical contract research in a boutique fashion while solving intricate scientific problems, primarily in the field of cancer treatment, diagnostics and prevention; additional focus – infectious diseases.

1.
Contract
Research
Capabilities
Bridging
the
gap
in
biotech
73
High
St.
Buffalo,
NY
14203
pgrifAin@buffalobiolabs.com
(716)849-­‐6810

2. 2
Buffalo
Biolabs
(BBL)
Mission
ü Address
the
demand
for
early
stage
discovery
that
bridges
the
gap
between
Academia
and
Big
Pharma
ü Provide
clients
with
preclinical
data
to
drive
product
development
and
support
fundraising
efforts
from
proof
of
concept
to
IND
PROFILE
Science-­‐intensive
Biotech
company
conduc4ng
contract
research
in
a
bou4que
fashion
while
solving
intricate
scien4fic
problems,
primarily
in
the
field
of
cancer
treatment,
diagnos4cs
and
preven4on;
addi$onal
focus
–
infec$ous
disease.
EXPERTISE
Highly
educated,
cohesive
research
team
of
31
employees
including
14
Ph.D’s
with
exper4se
in
target/drug
discovery
and
preclinical
valida4on.
Over
1,000
years
of
combined
experience
in
academia
&
biotech.
INCEPTION
Integra4on
of
veteran
research
teams
from
Cleveland
BioLabs,
Inc.
(CBLI)
and
Roswell
Park
Cancer
Ins4tute
(RPCI).
Jointly,
these
teams
have
brought
several
drug
candidates
from
hypothesis
to
clinical
trials.
CUSTOMERS
RPCI,
CBLI,
other
local
Western
New
York
and
East
Coast
biotech
companies
(Incuron,
Tar4s,
Everon,
Panacela
Labs,
Felicitex,
etc.)

3. 3
BBL
Contract
Types
ü Fully
outsourced
research
needs
Broad
set
of
goals,
ini$ally
non-­‐determinis$c,
shi8ing
scope
ü Problem
solving
Applying
collec$ve
exper$se
towards
a
single
issue
ü Proof
of
Concept
Narrow
goals,
clearly
desired
outcomes
ü Streamlined,
long
term
capability
extension
Ideal
for
clients
that
do
not
operate
full-­‐fledged
research
facili$es
or
need
augmenta$on
of
their
efforts
with
proven
exper$se.
ü Project/Vendor
Management
Help
clients
manage
disparate
research
segments,
combined
from
BBL
and
external
vendors
including
Shared
Resources
of
Roswell
Park.

4. 4
Unique
Advantages
ü Freeing
seemingly
“stuck”
projects
Sophisticated
animal
models
at
industrial
scale
–
statistical
signi6icance
of
border-­‐line
effects
Integrated
approach
–
combine
modern
molecular,
cellular,
tissue
and
organism-­‐level
methodologies
ü Access
to
array
of
exceptional
facilities
of
Roswell
Park
Cancer
Institute,
close
collaborator
of
BBL
Research
Genomics,
microarrays,
HTS,
FACS,
TMA,
collection
of
primary
tumors,
access
to
clinical
samples
http://www.roswellpark.edu/shared-resources
ü Positioning
project
for
investment/funding
decision
Equipped
to
handle
complex
PoC
efforts
Established
track-­‐record
of
bringing
new
drug
candidates
from
early
discovery
to
IND
ü State-­‐of-­‐the-­‐art
core
facilities
Sophisticated
equipment
and
methodology
Combining
academic
depth
with
industrial
power
and
experience

5.
BBL
Labs
Corporate
Customers
BBL
Cores
Academic
partners
Histology
Core
Animal
Core
Chemistry
and
Bioanalytics
Immunology
Lab
Preclinical
Lab
Validation
Lab
Cell Biology
Lab
Microbiology
Lab
RPCI SBMRI
Services
&
Support
Applied
Research
CBLI Incuron Felicitex Everon
Research/Service
Contracts
5
BBL
Contract
Research
Research
Collaborators
…

6. 6
Examples
of
Research
and
Service
Activities
Customer:
CBLI
R&D
tasks:
Establish
an4cancer
efficacy
of
EntolimodTM
(protein-­‐based
drug
candidate)
in
preclinical
models
Service
tasks:
Bioanaly4cal
support
of
EntolimodTM
clinical
trials
Customer:
Incuron,
LLC
R&D
tasks:
Assess
in
vitro
and
in
vivo
effects
of
combining
CBL0137
(small
molecule
drug)
with
other
an4cancer
drugs
Service
tasks:
PK/PD
analysis
in
support
of
CBL0137
clinical
trials
CBLI
Histology
Core
Animal
Core
Preclinical
Lab RPCI
Incuron
Histology
Core
Animal
Core
Validation
Lab
RPCI
Chemistry and
Bioanalytics
Chemistry and
Bioanalytics

7. 7
Research
Capabilities
• extensive
experience
in
mechanis4c
and
efficacy
studies
in
a
variety
of
in
vitro
and
in
vivo
models
• iden4fica4on
&
valida4on
of
molecular/cellular
PD
biomarkers
• establish
therapeu4c
window,
assess
impact
of
regimen,
and
evaluate
routes
of
administra4on
• access
to
a
variety
of
mouse
models
(incl.
gene
KO,
chimera,
etc.)
Preclinical
Lab
Validation
Lab
Cell Biology
Lab
• iden4fica4on,
targe4ng,
and
valida4on
of
novel
pharmacological
targets
and
drugs
• development
of
cell-­‐based
assays
for
targeted
drug
screening
• bio-­‐potency
and
target
specificity
of
drug
candidates
in
mul4ple
cell
lines
• efficacy
vs.
dose-­‐limi4ng
toxicity,
drug
combina4ons
in
animal
models
• assessment
of
cellular
drug
response
• cul4va4on,
frac4ona4on
and
iden4fica4on
of
drug-­‐sensi4ve
and
resistant
cell
types
• analysis
of
cellular
pathways,
prognos4c,
diagnos4c,
and
efficacy
markers
• ex
vivo
phenotype
and
drug
response
analysis
of
target
4ssues

8. 8
Research
Capabilities
(contd)
• extensive
experience
in
molecular
and
applied
immunology
developing
and
tes4ng
new
reagents
for
immunotherapy
and
immunodiagnos4cs
• development
of
sensi4ve
and
robust
immuno-­‐assays,
other
bioaffinity
assays,
screens
• custom
diagnos4c
and
therapeu4c
an4bodies
• protein-­‐based,
virus-­‐based
and
other
immunomodulatory
drug
research
Immunology
Lab
Microbiology
Lab
A
typical
research
project
involves
contribuTon
of
experts
from
2-­‐3
Lab
teams
as
well
as
Core
faciliTes.
AddiTonal
experTse
and
resources
(e.g.
TMAs,
HTS,
genomics)
are
engaged
via
subcontracTng
of
academic
partners
(such
as
Roswell
Park
Cancer
InsTtute)
• in
vitro
and
in
vivo
(mouse
models)
support
of
an4-­‐infec4ve
drug
development
• experienced
with
bacterial
and
fungal
pathogens
• in
vitro
tes4ng
of
an4microbial
potency
and
toxicity
on
human
cells,
support
of
SAR
• an4-­‐infec4ve
efficacy
by
survival
and/or
pathogen
burden
readouts

9. 9
Core
Service
Capabilities
• access
to
state-­‐of-­‐the-­‐art
animal
facility
• unique
colonies
of
mice
including
syngeneic
and
xenogra_
models
• variety
of
animal
models
including
cancer,
infec4on,
irradia4on,
chemical
tox
• expertly
designed
and
conducted
animal
studies
of
desired
scope
(tox,
survival
efficacy,
etc.),
scale
(from
single
to
thousands
of
mice),
types
of
treatment
(surgical,
various
admin
routes)
Animal
Core
Histology
Core
Chemistry
Bioanalytics
• pathology,
histomorphology
and
immunohistochemistry
• prepara4on
and
histological
analysis
of
samples
from
all
4ssues
types
• rou4ne
&
customized
methodology,
experienced
interpreta4on
of
results
• high-­‐end
histology
microscopes,
microtomes,
cryostats
• professional
analy4cal
support
of
pharmacological
studies
• formula4on
and
analysis
of
drug
substances
for
in
vitro
and
in
vivo
studies
• solubility,
stability,
toxicity,
PK
and
PD
studies
of
chemical
and
biological
drug
candidates
• specialized
equipment
including
HPLC
and
LC-­‐MS
Providing
robust
methodology
support
of
integrated
research
projects
and
direct
services
to
customers.

10. 10
Example
Featured
Research
Area
Antimicrobial
Drug
Development
Chemistry
Core
Animal
Core
Microbiology
Lab
RPCIIn
Vitro
Evalua9on
Potency
of
drug
candidates
⇒
MIC
against
major
fungal
pathogens
Candida
and
Aspergillus
spp.
⇒ MIC
and
MBC
against
aerobic
bacterial
pathogens
(Staphylococcus,
Enterococcus,
etc.)
Toxicity
⇒
on
a
panel
of
representa4ve
mammalian
cell
lines
Acquired
drug
resistance
⇒Drug
candidate
tes4ng
vs.
standard-­‐of-­‐care
In
Vivo
Evalua9on
Toxicity,
PK
⇒ formula4on,
maximum
tolerated
dose
(sMTD
and
rMTD)
⇒ pharmacokine4cs,
4ssue
distribu4on
Potency
⇒ mouse
models,
including
immunosuppressed
mice
models
of
candidiasis
and
aspergillosis
⇒ compare
administra4on
routes
(i.v.,
i.p.,
oral,
oropharyngeal),
treatment
regimens
⇒ endpoints:
survival,
pathogen
burden,
4ssue
damage
⇒ biomarkers
of
efficacy,
mechanis4c
studies