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
July
1, 2014
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
(Registrant’s
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 8.01 Other events
Agenus Inc. announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus’ Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. In this Phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year 1-7. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival.
In addition to the long-term survival data, vaccine treated patients had a median progression-free survival (PFS) of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone1. Importantly, 22% of patients were alive and without progression at 24 months and continue to be followed for survival.
The full text of the press release issued in connection with the announcement is being filed as Exhibit 99.1 to this current report on Form 8-K.
References
1. Ballman KV, Buckner JC, Brown PD, et al. The
relationship between six-month progression-free survival and 12-month
overall survival end points for phase II trials in patients with
glioblastoma multiforme. Neuro Oncol. 2007;9:29–38.
2. Lamborn
KR, Yung WK, Chang SM, et al. Progression-free survival: an important
end point in evaluating therapy for recurrent high-grade gliomas. Neuro
Oncol. 2008;10:162–170.
3. Wong ET, Hess KR, Gleason MJ, et al.
Outcomes and prognostic factors in recurrent glioma patients enrolled
onto phase II clinical trials. J ClinOncol. 1999;17:2572–2578.
4.
Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in
combination with irinotecan in recurrent glioblastoma. J Clin Oncol.
2009;27:4733–4740.
5. Kreisl TN, Kim L, Moore K, et al. Phase
II trial of single-agent bevacizumab followed by bevacizumab plus
irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol.
2009;27:740–745.
6. Vredenburgh JJ, Desjardins A, Herndon JE
2nd, et al. Bevacizumab plus irinotecan in recurrent glioblastoma
multiforme. J Clin Oncol. 2007;25:4722–4729.
7. Sathornsumetee
S, Desjardins A, Vredenburgh JJ, et al. Phase II trial of bevacizumab
and erlotinib in patients with recurrent malignant glioma. Neuro Oncol.
2010;12:1300–1310.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibit is filed herewith:
99.1 Press Release dated July 1, 2014
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. |
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|
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Date: July 1, 2014 |
By: |
/s/ Garo H. Armen |
Garo H. Armen |
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Chief Executive Officer |
EXHIBIT INDEX
Exhibit No. |
Description of Exhibit |
|
99.1 |
Press Release dated July 1, 2014 |