-- Median Overall Survival Nearly Double than Expected with Standard of Care Alone LEXINGTON, Mass.--(BUSINESS WIRE)--July 01, 2014--
Agenus Inc. (NASDAQ: AGEN), announced final formula from a single-arm, multi-institutional, open-label, Phase 2 investigate display that patients with newly diagnosed glioblastoma multiforme (GBM) who perceived Agenus’ Prophage autologous cancer vaccine combined to a customary of caring treatment, lived scarcely twice as prolonged as expected. In this Phase 2 study, 50% of a patients lived for dual years, an enlivening outcome for a cancer that mostly kills patients within one year (1-7) . Prophage patients demonstrated a median altogether presence of approximately 24 months and 33% of patients sojourn alive during 2 years and continue to be followed for survival.
“These information advise that Prophage is generating an effective defence response that is translating into an prolongation in presence distant over what is historically seen in patients with GBM. These information yield a procedure for a definitive, randomized clinical trial,” conspicuous Andrew Parsa, MD, PhD,Principal Investigator of a investigate and a Michael J. Marchese Professor and Chair of a Department of Neurological Surgery during a Feinberg School of Medicine during Northwestern University. “Glioblastoma tumors are mostly resistant to customary therapies and a extended progression-free presence and suit of long-term survivors is really encouraging.”
In further to a long-term presence data, vaccine treated patients had a median progression-free presence (PFS) of scarcely 18 months, approximately dual to three-times longer than patients treated with deviation and temozolomide alone(1) . Importantly, 22% of patients were alive and but course during 24 months and continue to be followed for survival.
Interestingly, a response to Prophage seems to be some-more conspicuous in those patients with reduction countenance of a checkpoint ligand PDL-1 on a white blood cells, suggesting that combinations of Prophage with checkpoint modulators like PD-1 antagonists competence make Prophage even some-more effective in a larger commission of patients with GBM.
“We trust that Prophage might play an critical purpose in changing a diagnosis model for patients with GBM,” conspicuous Garo Armen, PhD, CEO and authority of Agenus Inc. “We are exploring partnerships for Phase 3 studies of Prophage in GBM. Additionally, we are vehement about a intensity combinations of Prophage with PD-1 antagonists and other checkpoint modulators in GBM.”
Prophage is an autologous cancer vaccine, and any studious receives vaccine prepared from their possess surgically resected tumor. As a result, a vaccine appears to assistance kindle a patient’s defence complement to conflict a growth formed on a spectrum of mutant proteins voiced by their possess tumor. Since many cancers outcome from an accumulation of pointless mutations, that furnish opposite mutant proteins in any patient, this proceed is dictated to away tailor any patient’s vaccine to optimally aim a defence conflict to that patient’s tangible tumor.
Phase 2 Prophage Study in Newly Diagnosed GBM
The Phase 2 single-arm hearing of Prophage in patients with newly diagnosed GBM undergoing sum sum resection includes 46 patients treated during 8 centers (UCSF, Columbia, UPENN, Miami, Valley Hospital, Northern Westchester Hospital, Oklahoma, Johns Hopkins, and Northwestern) opposite a US. Patients were treated with surgical resection, deviation and temozolomide as a customary of caring in further to Prophage vaccination. The conspirator was allied to patients with surgically resectable newly diagnosed GBM on premonitory factors such as age, Karnofsky Performance Score, and MGMT methylation status. Analyses of information collected to date uncover some-more than 50% of a patients were alive during dual years and patients continued to be followed. These formula prove estimable alleviation when compared to expectations for patients treated with a customary of caring (gross sum resection and deviation and temozolomide), that is 26% of patients alive during 24 months.(1)
Median altogether presence (OS), a primary endpoint of a trial, is 23.8 months and stays durable in patients treated with Prophage. For a customary of caring alone, median OS presence rate is 14.6 months.(1) PFS information stays durable with prior reports with a median PFS of 17.8 months and scarcely 22% of patients alive but course during 24 months.
The Phase 2 memorable and newly diagnosed trials are being sponsored by Dr. Parsa and essentially have been upheld by appropriation from a American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society, and National Cancer Institute Special Programs of Research Excellence. Dr. Parsa has not perceived any financial support or responsibility payment for this work or for consulting activities on seductiveness of Agenus. He does not have an equity seductiveness in Agenus or a financial attribute with a company.
About Glioblastoma Multiforme (GBM)
The occurrence rates of primary virulent mind and executive shaken complement cancers have increasing over a final 3 decades.(8) The American Cancer Society estimates that some-more than 23,000 virulent tumors of a mind or spinal cord will be diagnosed during 2013 in a US, and that some-more than 14,000 people will die from these tumors. (9) GBM is a many common primary virulent mind growth and accounts for a infancy of diagnoses. It has been compared with a quite bad prognosis, with presence rates during one and 5 years equaling 33.7% and 4.5%, respectively.(10) The stream customary of caring for patients with newly diagnosed GBM is surgical resection followed by fractionated outmost lamp radiotherapy and systemic temozolomide(11) ensuing in a median OS of 14.6 months(12) formed on information from a randomized Phase 3 trial. Although this diagnosis can lengthen survival, it is not antidote and a immeasurable infancy of patients with GBM knowledge memorable disease, with a median time to regularity of 7 months.(13) From a time of recurrence, a median presence is 3 to 9 months.(1-7) Current diagnosis options for patients with memorable GBM, embody surgery, chemotherapy (i.e., CCNU, temozolomide), bevacizumab, and radiotherapy.
About Prophage Series Vaccines
Prophage Series vaccines are individualized cancer vaccines subsequent from any patient’s possess tumor. As a outcome of a individualized nature, any Prophage Series vaccine contains a accurate signals (antigenic fingerprint) of a patient’s sold cancer and allows a body’s defence complement to aim usually cells temperament this specific fingerprint. Such high pointing in immunological targeting represents a clearly opposite process for treating cancer compared to required anti-cancer treatments such as chemotherapy or deviation therapy. These required therapies means side effects, that are infrequently debilitating.
Prophage Series vaccines are formed on Agenus’ feverishness startle protein height technology. For some-more information about Prophage Series vaccines and Agenus’ feverishness startle protein platform, greatfully revisit http://agenusbio.com/science/prophage.php.
Agenus is an immuno-oncology association building a portfolio of checkpoint modulators (CPMs), feverishness startle protein vaccines and adjuvants. Agenus’ checkpoint modulator programs aim GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s exclusive find engine Retrocyte Display(R) is used to beget entirely tellurian healing antibody drug candidates. The Retrocyte Display height uses a high-throughput proceed incorporating IgG format tellurian antibody libraries voiced in mammalian B-lineage cells. Agenus’ feverishness startle protein vaccines for cancer and spreading illness are in Phase 2 studies. The company’s QS-21 Stimulon(R) adjuvant height is extensively partnered with GlaxoSmithKline and Janssen and includes several possibilities in Phase 3 trials. For some-more information, greatfully revisit www.agenusbio.com, or bond with a association on Facebook, LinkedIn, Twitter and Google+. For some-more information, greatfully revisit www.agenusbio.com.
This press recover contains forward-looking statements, including statements per clinical hearing activities, a announcement of data, and a intensity focus of a Company’s technologies and product possibilities in a impediment and diagnosis of diseases. These forward-looking statements are theme to risks and uncertainties that could means tangible formula to differ materially. These risks and uncertainties include, among others, a factors described underneath a Risk Factors territory of a Quarterly Report on Form 10-Q filed with a Securities and Exchange Commission for a duration finished Mar 31, 2014. Agenus cautions investors not to place estimable faith on a forward-looking statements contained in this release. These statements pronounce usually as of a date of this document, and Agenus undertakes no requirement to refurbish or correct a statements. All forward-looking statements are specifically competent in their entirety by this cautionary statement. Agenus’ business is theme to estimable risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give clever care to these risks and uncertainties.
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10. Central Brain Tumor Registry of a United States (CBTRUS) 2010 CBTRUS statistical report: primary mind and executive shaken complement tumors diagnosed in a United States in 2004-2006. http://www.cbtrus.org/reports/reports.html
11. National Comprehensive Cancer Network clinical use discipline in oncology-central shaken complement cancers. v.1.2010.
12. Stupp, R., et al., Radiotherapy and consequent and adjuvant temozolomide for glioblastoma. NEngl J Med, 2005. 352(10): p. 987-96.
13. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: rising accord on a benefits. Neurology. 2007;68(21):1762–1763. doi: 10.1212/01.wnl.0000266866.13748.a9.
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