UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
March 9, 2011
Date of Report (Date of earliest event reported)
AGENUS INC.
(Exact name of registrant as specified in its charter)
DELAWARE | 000-29089 | 06-1562417 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
3 Forbes Road Lexington, MA |
02421 | |
(Address of principal executive offices) | (Zip Code) |
781-674-4400
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 | Regulation FD Disclosure |
On March 9, 2011, Agenus Inc. presented a corporate overview at the 31st Annual Cowen and Company Health Care Conference at the Boston Marriott Copley Place Hotel.
The full presentation is being furnished as Exhibit 99.1 to this current report on Form 8-K.
Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
The following exhibit is furnished herewith:
99.1 March 9, 2011 Conference Presentation
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AGENUS INC. | ||||||||
Date: March 9, 2011 |
By: | /S/ SHALINI SHARP | ||||||
Shalini Sharp | ||||||||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit |
Description of Exhibit | |
99.1 | March 9, 2011 Conference Presentation |
![]() Corporate Presentation
March 2011
Exhibit 99.1 |
![]() 2
Forward-Looking Statement
This presentation contains forward-looking statements including statements
regarding the companys lead product candidates Oncophage
®
, Prophage Series, formerly known as
Oncophage, (vitespen; formerly HSPPC-96), QS-21 Stimulon
®
and HerpV, formerly AG-707,
(including, but not limited to, the timing of product development, launch and
product revenues), the successful development of the Companys products
by collaborative partners, the companys clinical trials (including,
but not limited to, trial initiation, enrollment, completion, analysis and
interpretation of results), the confirmation of Oncophage subgroup analyses, the
regulatory approval process (including, but not limited to, dates and locations of
filings), research programs and other future events and operations. These
forward-looking statements involve uncertainties and risks that are
described under Risk Factors of the Companys Form 10-Q as filed
with the Securities and Exchange Commission for the period ended September 30,
2010. Actual
results could differ materially from these forward-looking statements.
|
![]() 3
A New Name
Our pipeline has moved beyond
autologous
antigen-based technologies
Our strategy focuses advancing our platform
technologies through collaboration
www.agenusbio.com |
![]() 4
Agenus Investment Highlights
QS-21
vaccine
adjuvant:
Royalty
potential
in
2013-2014
Oncophage®
Prophage Series of therapeutic cancer vaccines advancing in
clinic
HerpV in genital herpes |
![]() 5
Product and Clinical Pipeline
Product
Indication
Phase 1
Phase 2
Phase 3
Market
Oncophage for Renal Cell Carcinoma
in Russia
Prophage for Glioma (recurrent)
Prophage for Glioma (newly diagnosed)
QS-21 in Non-Small Cell Lung Cancer QS-21 in
Melanoma QS-21 in Malaria
QS-21 in Shingles
partnered with GSK
partnered with GSK
partnered with GSK
partnered with GSK
QS-21 in Alzheimers Disease QS-21 in multiple undisclosed
vaccines partnered with Janssen
HerpV for Genital Herpes |
![]() 6
QS-21: Maturing Pipeline,
Addressing
10B+ Market
Clinical indications under
investigation (global incidence)
NSCLC (lung: 1.5m)*
Alzheimer's disease (prevalence:
26.6m)**
Malaria (250m)**
HIV (2.6m)**
AML (leukemias: 331k)*
Tuberculosis (9.3m)**
Varicella-zoster (US: 1m)***
Prostate cancer (783k)*
Breast cancer (1.3m)*
Melanoma (132k)****
22
14
4
0
5
10
15
20
25
Total
Vaccines
Clinical
Phase 3
QS-21 Pipeline
*ACS Global Cancer Facts & Figures 2007
**Wikipedia
***NIAID
****WHO |
![]() 7
QS-21: Significant Clinical Progress
GlaxoSmithKline
Phase 3 NSCLC study launched in 2007 (MAGE-A3)
Phase 3 (n=2,270) ongoing; largest trial conducted in NSCLC
Phase 2b (n=180): 25% reduction in recurrence vs. placebo
Phase 3 melanoma study launched Dec. 2008 (MAGE-A3)
Phase 3: n=1,300
Phase 3 malaria study launched March 2009
Phase 3: n=16,000, last patient expected to be dosed Feb. 2011
Phase 2: 53% reduction in clinical episodes of malaria
Phase 3 shingles study launched in 2010
Two Phase 3 studies, n=15,000 per study
GSK/Abbott MAGE-A3 diagnostic agreement
JANSSEN(J&J)/Pfizer
Phase 2 Alzheimers disease study launched in 2007
Janssen/GE collaboration to identify early markers of Alzheimers
|
![]() 8
The PROPHAGE Series of Cancer Vaccines |
![]() 9
PROPHAGE Series: 1
st
Approved
Cancer Vaccine
Patient-specific HSP-based therapeutic cancer vaccine
Theoretically applicable to almost any cancer
>850 patients worldwide safely treated in 8 cancers
Simple out-patient injection
Manufactured in less than 10 hours
Phase 3 adjuvant RCC data has strengthened over time |
![]() 10
PROPHAGE Series Clinical Overview
Signals of clinical activity observed in 8 cancers (US incidence)*
Kidney (58,240)
Melanoma (68,130)
Brain (22,020)
Colorectal (142,570)
Lung (222,520)**
Pancreatic (43,140)
Gastric (21,000)
Non-Hodgkins lymphoma (65,540)
Efficacy signals include tumor-specific and innate immune
responses, tumor responses, RFS, PFS, OS across tumor types
Efficacy appears most pronounced in earlier-stage patients
Combination trials allow for more advanced disease
Well tolerated; low toxicity profile
*ACS Cancer Facts Figures 2010
**Manufacturing feasibility only |
![]() Oncophage®
Demonstrates
Statistical
Significance in ECOG Intermediate Risk RCC Patients |
![]() 12
Overall Survival, Intermediate-Risk |
![]() 13
PROPHAGE Opportunity: Glioma
Over 20,000 cases of brain cancer diagnosed each year in the US
Phase 2 trial underway in newly diagnosed glioma
Actively enrolling patients (n=50); recently expanded to 10 sites
Prophage + standard of care [radiation therapy plus Temodar (temozolomide)]
No significant toxicities observed to date
Phase 1/2 trial in recurrent glioma
Phase 2 portion actively enrolling patients (n=30)
Phase 2 survival data
Median survival 44 weeks, compared to historical median of 26 weeks
70% of patients survived beyond 36 weeks
40% survived up to or longer than 1 year
All patients tested mounted innate immune response, 92% mounted adaptive
CD4/CD8 t-cell response
Potential for accelerated registration pathway in the US
Investigator-sponsored (UCSF); funded by NCI, patient advocacy
groups |
![]() NCCN Practice Guidelines (2011)
Treatment
NCCN Practice Guidelines (2011)
Treatment
Overview: Recurrent GBM
Overview: Recurrent GBM
Agents listed in the practice
guidelines
Median OS Months
Platinum Based Regimens¹
7.4
PCV²
7.6
Cyclophosphamide³
4.0
Carmustine wafer
4
7.5
Temozolomide
5
Not Reported/median PFS 5 mos.
Bevacizumab
6
9.2
Prophage Series G-200
7
>10 months
1
Yung
WK,
et
al.
J
Clin
Oncol
1991
(Population
included
AA
and
GBM)
,2
Kappelle
AC,
et
al.
Neurology
2001
(Procarbazine,
Lomustine,
Vincristine
combination),
3
Chamberlain
MC,
Tsao-Wei,
DD.
Cancer
2004
4
Brem
et
al.
Lancet
1995,
5
Perry
et
al.
Cancer
2008,
6
Friedman
et
al.
J
Clin
Oncol
2009,
7
Parsa
et
al.
18th
International
Conference
for
Brain
Tumor
Research
and
Therapy |
![]() NCCN Practice Guidelines (2011)
NCCN Practice Guidelines (2011)
Treatment Overview: Newly Diagnosed GBM
Treatment Overview: Newly Diagnosed GBM
Agents listed in the practice guidelines
Median PFS/OS
Months
Carmustine
wafer¹
PFS 5.9
OS 13.9
Radiation/Temozolomide²
PFS 6.9
OS 14.6
XRT/TMZ +
Prophage Series G-100 (n=15)
N/A
1
Westphal et al. Neuro-Oncology 2003
2
Stupp et al. NEJM 2005 |
![]() 16
"Significant Advances" (p< 0.05) in Epithelial Malignancies in
Patients Not Selected on the Basis of Molecular Characteristics
Drug
Tumor
Survival Gain (months)
Gemcitabine
Pancreas
1.5
Bevacizumab
Colon
2.2
Erlotinib
Pancreas
0.4
Bevacizumab
NSCLC
2
Sorafenib
Renal
2
Temozolamide
GBM
2.5
Docetaxel
Prostate
2.4
Topotecan
Cervix
2.3
Cetuximab
Colon
1.5
Erlotinib
NSCLC
2
Cetuximab
NSCLC
1.2
Bevacizumab
Breast
1.5
Data
from
Stewart
DJ,
Kurzrock
R.
Cancer:
the
road
to
Amiens.
J
Clin
Oncol
2009;27:32833. |
![]() 17
A New Era for Cancer Vaccines
Provenge FDA approval
Ipilimumab imminent FDA PDUFA date
Rationale for combinations with vaccines
Newly-created opportunity to use combinations |
![]() 18
Genital Herpes and HerpV Overview
Genital herpes is the most prevalent viral STD
Approximately 55 million Americans/Europeans affected
80% of patients suffer symptomatic recurrences
Virus establishes life-long latency
HerpV is an off-the-shelf HSP-based therapeutic vaccine
candidate for treatment of genital herpes
Contains 32 immunogenic peptides of the herpes genome
Promising Phase 1 results
100% of evaluable patients receiving HerpV+QS-21 had CD4+T-cell
response
63% had CD8+ T-cell response; seeing both is unprecedented
Safety profile established
Potential to partner for Phase 2 and beyond
Potential platform technology |
![]() 19
2011 Goals and Objectives
Continued clinical advancement of QS-21 vaccine adjuvant
Possible
Phase 3 data announcements
Partnerships for Oncophage®
in RCC in Europe/Russia
Advancement of Prophage in glioma (brain cancer)
Recurrent glioma data presentation mid-year
Exploration of accelerated US regulatory pathway
Initiation of pediatric trial mid-year
Potential for partnership
Initiation of Prophage Series combination trials
Development of HerpV in genital herpes
Data publication mid-year
Potential for partnership opportunity
In-licensing agreements and new corporate/academic
collaborations |
![]() 20
Balance Sheet
December 31, 2010 ($ millions)
Cash and short-term investments
$19.8
Other current assets
1.1
Net plant and equipment
6.2
Other long-term assets
3.8
Total assets
$30.9
Current liabilities
$40.1
Long-term liabilities
5.5
Stockholders
equity
(14.7) Total liabilities and stockholders
equity
$30.9 |
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