EX-99.1 2 dex991.htm POWER POINT PRESENTATION Power Point presentation
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FORWARD LOOKING STATEMENTS
Statements in this
PowerPoint presentation
that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but are not limited to,
statements
about
BiovaxID
and
AutovaxID
and
any
other
statements
relating
to
Biovest's
products, product candidates, and product development programs. Such statement may
include, without limitation, statements with respect to the Company's plans, objectives,
expectations and intentions and other statements identified by words such as "may",
"could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends",
"plans" or similar expressions. Such forward-looking statements involve known and
unknown
risks,
uncertainties,
and
other
factors
that
may
cause
Biovest's
actual
results
to
be materially different from historical results or from any results expressed or implied by
such forward-looking statements. These factors include, but are not limited to, risks and
uncertainties
related
to
the
progress,
timing,
cost,
and
results
of
Biovest's
clinical
trials
and product development programs; difficulties or delays in obtaining regulatory approval
for
product
candidates;
competition
from
other
pharmaceutical
or
biotechnology
companies;
and
the
additional
risks
discussed
in
Biovest's
filings
with
the
Securities
and
Exchange Commission. All forward looking statements are qualified in their entirety by
this cautionary statement, and Biovest undertakes no obligation to revise or update this
PowerPoint presentation to reflect events or circumstances after
the date hereof.


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Biovest International
Corporate Overview
20 year-old company
GMP Manufacturer of Biologics
Automated Cell Culture Systems
Long history with NCI, Biotech and Academia
Acquired
rights
to
BiovaxID
®
in
2003
Revenue generating automated instrumentation
division


4
BiovaxID
Lead product target to treat 34,000 new indolent follicular B cell
lymphoma patients per year
Superior
Technology:
Only
therapy
shown
in
peer-reviewed
publication to induce both clinical and molecular remission in
patients with follicular lymphoma
164,000 new patients with B cell non-Hodgkin’s lymphoma and
related diseases each year
worldwide
Only therapy for follicular lymphoma developed in collaboration with
the National Cancer Institute
Only autologous
immunotherapy containing complete copy of a
patient’s own target protein


5
B-cell lymphomas and related diseases:  Pipeline opportunities of BiovaxID
Disease or category
Estimated new cases per year
North
America
Europe
ROW
1
Tot
Indolent Follicular NHL
Current Pivotal Phase III Clinical
Trial
16,000
11,500
6,800
34,300
Follow-on indications –
using same vaccine process and requiring only Phase III Clinical Trials
Indolent NHLs
Other subtypes
(e.g., MALT; Nodal; Small lymphocytic)
6,150
4,800
2,800
13,750
Aggressive NHLs
(e.g. Diffuse; Mantle-cell; Mediastinal
large-
cell; Lymphoblastic; Burkitt-like; Burkitt’s
lymphoma)
29,000
22,000
12,600
63,600
Multiple Myeloma
17,500
19,000
15,500
52,000
1:ROW: Rest of World
Data for North-America covers US and Canada; Europe cover France, Germany, Italy, Spain, and the United Kingdom;
Note: Numbers reflect rounding.
Sources: National Cancer Institute, 1999; Datamonitor
OncoVision
v3.0


6
Rituxan: Rapid uptake of  a targeted biologic in the NHL market
143,700
140,800
138,000
146,600
149,600
152,600
155,600
161,900
165,200
168,500
25.2
17.7
12.2
37.9
53.4
60.2
65.2
75.2
82.0
85.0
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
- US Rituxan-Treated Patients (NHL Only) -
in % of total NHL treated population
Sources:
UBS
Warburg
Report
May
2003,
Rodman
&
Renshaw
Monthly
Oncology
Report
June
2005,
Genentech
website
-
www.gene.com,
accessed
in
Dec.
2006


7
Source:
Redbook,
IMS
health,
ING
April
2005;
Companies’
websites
Nov.
2005
Avastin
®
Erbitux
®
Herceptin
®
Rituxan
®
Zevalin
®
Tumor-type
Metastatic
Colorectal
Metastatic
Colorectal
Breast Cancer
Follicular NHL
NHL
Type of Product
monoclonal
antibody
monoclonal
antibody
monoclonal
antibody
monoclonal
antibody
monoclonal
antibody
Launch Date (US)
03/2004
02/2004
10/1998
12/1997
05/2002
Average Price per
year or treatment
course
($US)
$52,250
$121,000
$64,000
$59,080
$60,000
2004 US Sales
($US, in MM)
$554.6
$260.8
$479.0
$1,574.0
$23.6
Comparable Products: Biotechnology cancer therapies command a premium
price in today’s market


8
Indolent follicular NHL -
Illustrative analysis of market potential
Illustrative Market
Penetration
Patients
treated per year
1
BiovaxID
Pricing Scenarios
2
$70,000
$100,000
$120,000
20%
6900
$483MM
$690MM
$828MM
50%
17150
$1.2B
$1.7B
$2.1B
85%
29000
$2B
$2.9B
$3.5B
1.
Based on a total of 34,300 new cases of indolent follicular NHL worldwide per year. 
2.
For illustrative purposes only


A Model Tumor Antigen
Ig
are composed of heavy and
light chains with highly specific
variable regions
the variable
regions of the heavy and light
chains combine to form unique
Ag-recognition site.  These
variable regions contain
determinants recognized as
Ags, or idiotypes.
Id can thus serve as a truly
tumor-specific antigen
The idiotype
(Id) of the surface
immunoglobulin receptor on a
given B cell malignancy is a
clonal
marker


10
BiovaxID
works by stimulating the immune system to destroy tumor cells
but not normal cells
All NHL tumor cells have
unique markers on their
surface
The human immune
system does not
recognize these cells as
dangerous
The unique  marker proteins
are used to make a vaccine
stimulating the immune
system to seek out and
destroy tumor cells and
nothing else
Tumor Biopsy
Vaccinate
patient


11
BiovaxID
complements current therapies for non-Hodgkin’s lymphoma
Debulk
Tumor
Designed to kill residual tumor cells
Designed to provide ongoing
immunosurveillance
for recurrent tumor
Chemotherapy
Monoclonal antibodies
(e.g. Rituxan)
Radiation therapy
Surgery
Use Patients Tumor Cells
to Produce BiovaxID
Administer BiovaxID
1
2
3


BiovaxID
is produced by a unique, patient-specific production process
2) Biovest’s
automated AutovaxID-C
bioreactor with its patient-specific
cartridge, produces idiotype
protein
1) Biopsy -
cancer cells are sampled and
idiotype
for vaccine is identified
3) Purified idiotype
conjugated
to a powerful immune
stimulant (KLH)
4) BiovaxID
administered with a second
immune stimulant (GM-CSF) and creates
a patient-specific anti-cancer immunity
12


13
The AutovaxID™
can be set up in minutes.
Control unit
Disposable culture
module
Refrigerated product storage
Introducing cells
Bar code ID scan
Programming
Mounting culture
module in control
unit


14
AutovaxID: Re-inventing cell production
AutovaxID
is a product extension of our existing
instrumentation business
Organizations worldwide targeted for AutovaxID
include researcher labs and universities, biotech &
pharmaceutical companies
Goal is to automate the cell production industry
New manufacturing facility for AutovaxID
production funded and in process
Razor/razor blade business model
Market will grow significantly with development of
personalized medicine applications
An AutovaxID
Desktop Bioreactor eliminates the need for a Clean Room,
allowing exponential production scalability


Phase 2 Data
Although this trial was not a
randomized, controlled trial,
the updated follow-up data
continue to suggest that
BiovaxID
vaccination may
result in long-term disease
free survival superior to that
of the National Cancer
Institutes ProMACE
chemotherapy-treated control
group as well as comparable
or superior to that of the
CHOP-R treated cohort
reported on by Czuczman
et
al
Long-Term Follow-Up of the Phase 2 Cohort
Santos C, Cohen CM, Arikian
S, Stern LS, Katz LM, Watson
TM, Stergiou
AM, Gause
BL. BiovaxID
Vaccine Therapy of
Follicular Lymphoma in First Remission: Long-Term Follow-
Up of a Phase II Trial and Status of a Controlled,
Randomized Phase III Trial. Am Soc of Hematol. 2005
8.0
2.2
6.9
0
1
2
3
4
5
6
7
8
9
Biov
axID
NCI Cohort/
ProMACE
CytaBOM
Czuczman/
CHOP-R
Median Disease Free Survival Comparison


45.0%
95.0%
0%
20%
40%
60%
80%
100%
Continuous
Remission
(CR)
Survival
-
Long-term
Results
of
Phase
II
(Median
Follow-up
of
9.2
Years; N=20)
With a median followup
of 9.2 years,
45% of patients remain in continuous
first CR at their most recent follow-up
-
Median
DFS
for
the
cohort
is
96.5 months (8.0 years)
At the same observation point, overall
survival remains at 95%; there have
been no additional reported mortalities
in this cohort
95% of patients
autologous
T-cell
response; 75% humoral
response
Santos C, Cohen CM, Arikian
S, Stern LS, Katz LM, Watson TM, Stergiou
AM, Gause
BL. BiovaxID
Vaccine Therapy of Follicular Lymphoma in First Remission: Long-Term Follow-Up of a Phase II
Trial and Status of a Controlled, Randomized Phase III Trial. Am Soc of Hematol. 2005
Striking early clinical results in treating NHL
Phase 2 Data: Results from an NCI cohort


Of the 20 patient cohort:
11 initially t(14;18)+, and
all 11 maintained their
status post-chemotherapy
One month following final
ID-KLH vaccination 8 of
these 11 patients
converted to t(14;18)-
(72.7%) 
All 8 continued to be
t(14;18)-
at the last time
point these samples were
analyzed (range 8 to 32
months following
vaccination)
Phase 2 Data
Ability to induce molecular remission
73%
100%
27%
0
2
4
6
8
10
Post-Chemotherapy
Post-Vaccination
BiovaxID
Converts 73% of t(14;18) Positive
Patients to t(14;18) Negative
t(14;18)+
t(14;18)-
73%
converted to
t(14;18)-


18
Independent study using BiovaxID
at the
Univ. of Navarra, N=25 patients
Design: Follicular lymphoma patients who
failed first line chemotherapy immunized with
BiovaxID
following 2
nd
remission.
Results: BiovaxID
provided first-ever increase
in disease free survival for follicular
lymphoma
Median DFS for BiovaxID-induced 2
nd
remission has not been reached, but is
>33 months; median DFS for 1
st
remission was 17 months.
20 of 25 treated patients developed a
BiovaxID
-induced anti-tumor immune
response.
For all 20 of these patients their 2
nd
BiovaxID-induced DFS was significantly
longer than their 1
st
DFS (P<.0001) –
a
“first”
in the treatment of this disease.
Independent published validation of BiovaxID: “..the first formal
demonstration of clinical benefit associated  with the use of a human cancer
vaccine." (Journal of the  National Cancer Institute 2006; 98:1292-1301).


Vaccination Results for 2
nd
Remission (Journal of the 
National Cancer Institute 2006; 98:1292-1301).
1
st
remission-median
DFS of 17 months
2
nd
remission
After BiovaxID, median
DFS not yet reached.
(33+ months).
Historical median duration 
of 2
nd
remission with CHOP
chemotherapy is 13 months.
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Immune response = longer remissions
Striking and statistically
significant 2
nd
remission
duration increase in
patients responding to
vaccine…
vs
non-responders
(whose 2
nd
remission
durations are of shorter
duration than their 1
st
remission)
20


Mantle Cell Lymphoma Clinical Trial Schema
LN Bx
EPOCH-R
6 cycles
Id/KLH + GM-CSF s.c.
0
12       16       20       24            32
EPOCH-R
Begins
EPOCH-R
Ends
-18
Weeks
n = 26
EPOCH-R –
Rituximab
on day 1
--
Continuous iv infusion of Etoposide, Doxorubicin and Vincristine
over 96 hrs (days 1-5)
--
Cyclophosphamide
iv on day 5
--
Prednisone days 1-5.
Id-KLH+GM-CSF –
0.5 mg autologous
Id + 0.5 mg KLH + 100
g/m
2
GM-CSF


Rationale
Strong CD4+ and CD8+ T cell responses
are essential for optimal anti-tumor
immunity.
The presence of B cells may inhibit the
induction of T cell dependent anti-tumor
immunity
Qin et al. Nat. Med, 1998.
Rituximab
induces severe depletion of B
cells from peripheral blood and lymphoid
tissues for 6-9 months.


Clinical Outcome
Following EPOCH-R,
CR in 92% of the patients
PR in 8% of the patients
With a median follow-up of 4 years,
Progression free survival is 19%
Overall survival is 81%


Conclusions –
MCL Vaccine Study
Antibody responses to KLH carrier were delayed
but present in 17/23 (74%) patients, and Id-
specific antibody responses were detected in
8/23 (35%) patients.
Tumor-specific T cell responses were detected in
20/23 (87%) patients following rituximab
containing chemotherapy regimen
These results suggest that severe B-cell
depletion does not impair induction of T-cell
responses


BiovaxID:  BV-301
6 months
6
-
12 months
Rest for immune
system to recover
PACE or CHOP-R
CR/CRu
Achieved
PATIENT
RANDOMIZATION
2:1
Up to a maximum of
12 months after
chemotherapy
Vaccine
Administered
Specific vaccine
Id-KLH/GM-CSF
Segment A
Segment B
Non-specific
vaccine
KLH/GM-CSF


Trial initially designed to enroll 563 total PACE treated patients
in order to complete 375 patients in Segment B (vaccine or
control)
Current data from trial (CR rate of 80-85%) suggest only
460 PACE patients needed to randomize 375 patients
Adaptive study design per current protocol assumptions requires
460-630 enrolled patients and 375 -
540 patients randomized*
Full accrual was projected at 5 years with 4 years of additional
follow up
*Depends on the proportion of new enrolled patients, due to CHOP-R amendment, allocated to PACE
chemotherapy, and disease free survival rates of placebo arm
BV 301 Phase 3 Trial : Enrollment/statistical assumptions with
PACE chemotherapy (interim analysis)
375 PACE treated patients need to be randomized in Segment B to obtain
80% power to detect difference in disease free survival in trial.
As of April 2008:
234 patients enrolled in segment A
177
patients
randomized
in
segment
B
(vaccine
or
control)
all
PACE
patients


Per-Protocol Sample (N=120) –
Disease Free Survival


28
Comparative analysis: increased survival is dependent upon immune
response
Data
published
Median
DFS
Overall
survival
% with
cellular
immune
response
% with
humoral
immune
response
% with
molecular
remission
Biovest
BiovaxID*
Yes
8.1 yr
95% after
8-10 yr
95%
75%
73%
Genitope
MyVax
No
3.1 yr
Not
reported
44%
48%
Not
reported
Favrille
FavID
No
Not
available
Not
reported
67%
20%
Not
reported
R-CHOP
Yes
Various
58-88%
after 5
years
Not
applicable
Not
applicable
Varies
*BiovaxID
is the only therapy using a complete copy of the patient’s own target antigen


BV301 Data Monitoring Committee (DMC)
On April 15, 2008, the DMC met to review an interim analysis of the
safety and efficacy data for the Phase 3 study. 
The analysis showed that BiovaxID™
continues to have a favorable
safety profile.
The DMC recommended Biovest unblind
the study for a final
analysis.
The final study report should contain data through August 29, 2008.  That date
signifies when the last randomized and vaccinated patient reaches 12 months
follow-up from their first injection.
The DMC Chairman has volunteered to participate in ongoing
regulatory meetings with the FDA and other Health Authorities
regarding unblinding
the results and seeking a pathway for
conditional and/or accelerated approvals.


Favorable Safety Profile –
SAEs
by Causality
and Timing
Table 2
Timing
Number of Subjects
During Chemotherapy
23
During Vaccine
7
After Vaccine
1
Unknown
1
Table 1
Relatedness
Number of Subjects
Possible
2
Unknown
25
Unlikely
3
Unrelated
2
30


Financial Information
Cash & cash equivalents
1,048,000
Total assets
6,902,000
Total risk bearing debt
18,332,000
Stockholder's Equity:
Common stock, $.01 par value, 300,000,000 shares authorized;
963,000
96,305,038 outstanding as of March31, 2008
Additional paid-in capital
69,590,000
Deficit accumulated
(104,761,000)
Total shareholders' deficit
(34,208,000)
Shares
outstanding
WA Exercise price
WA Term
Common shares outstanding
96,305,038
Employee stock options
9,751,092
0.72
7.5
Warrants
28,498,530
0.55
9.35
Total fully diluted shares
134,554,660
For 6 months ended March 31,
2008
2007
Revenue
2,815,000
2,879,000
Net income/(loss)
(8,133,000)
(29,400,000)
As of 3/31/2008
Income Statement
Equity
Fully Diluted Shares Outstanding


Questions?