Key Developments: Agenus Inc (AGEN.W)
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21 May 2013
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Latest Key Developments (Source: Significant Developments)
Agenus Inc. Announces Publication Of Key Data Showing Antitumor Activity Of Prophage Vaccine (HSPPC-96) In Clinical Cancer Research
Agenus Inc. announced the publication of key clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96; vitespen) to treat patients with recurrent glioblastoma multiforme (GBM). The data from the Phase 1 trial were published online by Clinical Cancer Research in an article titled, Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein, by Andrew T. Parsa, MD, Ph.D., Professor in the Department of Neurological Surgery at the University of California, San Francisco (UCSF), and principal investigator for the trial. A total of 12 patients with a mean age of 52 years were treated in the Phase 1 trial receiving HSPPC-96 as a single-agent therapy. Testing of peripheral blood leukocytes (PBLs) before and after vaccination revealed a significant peripheral immune response specific for the peptides bound to HSP-96, in 11 of the 12 patients treated. Brain biopsies of immune responders after vaccination revealed focal CD4, CD8 and CD56 IFN-gamma positive cell infiltrates, consistent with tumor site-specific immune responses. Immune responders had a median survival of 47 weeks after surgery and vaccination, compared to 16 weeks for the single non-responder. There were no serious adverse events associated with vaccine administration. The study aims to advance the treatment of GBM, the most common and most malignant form of brain cancer. Full Article
Agenus Inc. Expands QS-21 License And Grants Right Of First Negotiation To GlaxoSmithKline Plc
Agenus Inc. announced that GlaxoSmithKline (GSK) and Agenus have amended the QS-21 license and manufacturing agreement to include additional rights for the use of Agenus' QS-21 Stimulon adjuvant in GSK Biologicals' adjuvant systems. In addition, Agenus has agreed to grant the vaccines company the first right to negotiate for the purchase of Agenus or certain of its assets. The first right to negotiate will expire after five years. Under the terms of the agreement, GSK will pay Agenus a non-refundable payment of $9 million, of which $2.5 million is creditable against future manufacturing technology transfer royalty payments. The agreement also includes royalty payments for an undisclosed indication upon commercialization of a vaccine product. Full Article
Agenus Inc. And ChemRar Enter Into Agreement In Area Of Personalized Cancer Vaccines
Agenus Inc. and NewVac LLC announced that they have entered into a license, development and manufacturing technology transfer agreement for Agenus' Oncophage (HSPPC-96; vitespen) vaccine. Oncophage is approved in Russia for the treatment of renal cell carcinoma (RCC; kidney cancer) in patients at intermediate risk of recurrence. Under the agreement, Agenus has granted NewVac an exclusive license to manufacture, market and sell Oncophage as well as pursue a development program of Oncophage in combination with NewVac's co-adjuvant technology in the Russian Federation and CIS countries. Agenus is entitled to receive a transfer price and/or royalties upon Oncophage product sales, and potential payments. Full Article
Antigenics, Inc. Announces Clinical Data Published In Vaccine Demonstrate Robust Immune Response With Agenus' Herpes Vaccine Containing QS-21 Adjuvant
Antigenics, Inc. announced positive results from a randomized, four-arm Phase 1 study of HerpV, a recombinant (off-the-shelf) therapeutic vaccine for the treatment of genital herpes, which included the Company's QS-21 Stimulon adjuvant. The results were published in the peer-reviewed journal Vaccine. HerpV is the most advanced HSV-2 vaccine currently in clinical development for the treatment of genital herpes. In this four-arm Phase 1 study, 35 herpes simplex virus type 2 seropositive patients received the vaccine plus QS-21 (HerpV), vaccine without QS-21, QS-21 alone, or placebo. Patients received three treatments at two-week intervals. All patients who were evaluable for immune response and received HerpV showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNy Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). The vaccine was well tolerated, with injection site pain as the most commonly reported adverse event. Agenus plans to advance HerpV into a Phase 2 study in 2012 that will measure the effect of vaccination on viral shedding in individuals infected with HSV-2. Experts in HSV-2 clinical research believe that a reduction in viral shedding could translate into clinical benefit. Full Article
Antigenics, Inc. Prices At Market Underwritten Offering Of Common Stock
Antigenics, Inc. announced the pricing of an at market underwritten offering of 13,725,491 primary shares of its common stock at a price of $0.51 per share with a group of investors including the Company's Chairman and CEO, Dr. Garo Armen. Agenus' common stock closed at $0.51 on August 10, 2011. After the estimated offering expenses payable by Agenus, Agenus expects to receive net proceeds of approximately $6.3 million. All of the shares in the offering are being sold by Agenus. The offering is expected to close on August 16, 2011, subject to customary closing conditions. William Blair & Company, L.L.C, is acting as the sole book-running manager for the proposed offering and Gleacher & Company Securities, Inc., a subsidiary of Gleacher & Company, Inc. (Nasdaq:GLCH) is acting as co-manager. Full Article
Antigenics, Inc.'s Herpes Study Results Presented At BIO International Convention Show Robust Immune Response
Antigenics, Inc.announced that results from its Phase I study of HerpV for the treatment of genital herpes will be presented by Dr. David Koelle, professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington School of Medicine, at the BIO International Convention in Washington, DC.HerpV is an investigational therapeutic vaccine being developed to treat herpes simplex virus-2 (HSV-2), the virus that causes genital herpes in infected patients. Results from the Phase 1 HerpV trial demonstrated that the vaccine candidate triggered a cellular immune response, stimulating both CD4+ and CD8+ T cells. In this four-arm, Phase 1 study, 35 HSV-2 seropositive patients received HerpV (designated in the study as AG-707 plus QS-21), AG-707, QS-21 alone, or placebo. Patients received three treatments at two-week intervals. The vaccine was well tolerated with injection site pain as the most common reported adverse event. All patients who were evaluable for immune response and received HerpV showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). This study is the first to demonstrate that heat shock proteins complexed to viral antigens induce an antigen-specific T cell response in humans. . Full Article
Agenus Inc. Announces Data From Phase 2 Brain Cancer Study With Prophage Series G-200
Agenus Inc. announced results from a Phase 2 clinical trial testing the Prophage Series G-200 vaccine (HSPPC-96; vitespen) in deadly recurrent brain cancer -- glioblastoma multiforme (GBM). The key objectives of the Prophage Series G-200 Phase 2 trial were to evaluate the overall survival rate, safety and immunological activity consistent with a tumor-specific immune response. The primary objective of the trial was to assess the survival rate at 26 weeks, which represents the average survival time for patients experiencing recurrence of their GBM. Results from this trial showed that 93% of the patients were alive at greater than or equal to 26 weeks after surgery and a median overall survival of 11 months (47.6 weeks). Results from pre-defined exploratory analyses of disease progression showed a median progression free survival (PFS) of approximately 5 months (20 weeks). Importantly, measures of immune response post vaccination with Prophage Series G-200 demonstrated a significant tumor-specific CD8+ T-cell response as well as innate immune responses as marked by a significant increase in levels of circulating NK cells. The Phase 2 trial was designed to enroll approximately 30 patients with recurrent high-grade GBM, the deadliest form of brain cancer. Patients underwent surgery to remove >90% of their tumors (also referred to as gross total resection), which were then used to manufacture Prophage Series G-200, a patient-specific heat shock protein based therapeutic vaccine. Full Article
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