Antigenics Inc.

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Antigenics history

  2009
June Survival data from an interim analysis of the global patient survival registry showed that patients with kidney cancer at intermediate risk of disease recurrence had approximately a 46 percent lower risk of death when treated with Oncophage. A promising trend for overall survival was shown in patients treated with Oncophage in the total population eligible for the study.
April Antigenics receives orphan drug status from the FDA for Oncophage in glioma, providing the company with potential market exclusivity for seven years from FDA marketing approval.

Oncophage named the “best therapeutic vaccine” by the World Vaccine Congress.
March Antigenics receives European orphan drug designation from the EMEA in glioma, providing the company with 10 years of potential market exclusivity if the product is approved for marketing in the EU.
  2008
November Final data from the investigator-sponsored Phase 1 trial of Oncophage in glioma, conducted at the Brain Tumor Research Center at the University of California, San Francisco, is presented at the Society for Neuro-Oncology’s Annual Meeting. The data showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months. Four patients survived beyond 12 months and one patient survived almost 2.5 years. The historical median survival for glioma patients is only 6.5 months post surgery.
October Antigenics submits a Marketing Authorization Application (MAA) for Oncophage to the European Medicines Agency (EMEA).
September The U.S. Food and Drug Administration (FDA) grants permission to allow for the export of Oncophage to Russia.
April The Russian Ministry of Public Health issues a registration certificate for the use of Oncophage (vitespen) in the treatment of kidney cancer patients at intermediate risk for disease recurrence.

Antigenics raises $21 million in a private placement of common stock and warrants to various institutional investors.

February Antigenics' previously announced Phase 3 metastatic melanoma study results are published in the Journal of Clinical Oncology .
January Antigenics raises $26 million through the sale of common stock and warrants to various institutional and accredited investors, including the company's chairman and CEO, Garo Armen, PhD.

Antigenics reports positive Phase 1 data on QS-21 in Acambis' influenza A vaccine. In the study, 90 percent of subjects who received vaccine plus QS-21 generated virus-specific antibodies following immunization. Based on the results, Acambis exercises its option for a commercial license to QS-21.
  2007
October Data from the investigator-sponsored Phase 1 trial of Oncophage in glioma at the Brain Tumor Research Center at the University of California , San Francisco (UCSF), is presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The data showed that 11 out of 12 patients exceeded the historical median benchmark of 6.5 months survival from time of recurrence and that all 12 treated patients demonstrated a significant immune response after vaccination with Oncophage ( P < .001).

Antigenics also announces that the first patient is registered in the investigator-sponsored Phase 2 trial of Oncophage in glioma at the Brain Tumor Research Center at the University of California , San Francisco (UCSF).
September Antigenics raises $5 million through the sale of common and preferred stock to an institutional investor. The investor has the option to invest up to an additional $15.25 million in the company.
August Antigenics completes submission of an application for marketing authorization with the Russian Ministry of Public Health for the use of Oncophage in the treatment of kidney cancer patients at intermediate risk of disease recurrence.
June GlaxoSmithKline (GSK) launched a Phase 3 clinical trial evaluating its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in non-small cell lung cancer. The vaccine contains GSK’s proprietary adjuvant system, which includes Antigenics’ QS-21 Stimulon adjuvant, for which Antigenics will receive future milestone payments and product royalties upon successful development and commercialization.
May Antigenics presented end-of-study results from its Phase 3 trial of Oncophage in kidney cancer at the annual meeting of the American Urological Association. The study showed that Oncophage significantly prolonged recurrence-free survival and improved overall survival in a large subgroup of intermediate-risk patients.
April An oral presentation of updated data from a Phase 1/2 investigator-sponsored trial of Oncophage in recurrent, high-grade glioma was presented at the 75th annual meeting of the American Association of Neurological Surgeons. Preliminary results from the study, being conducted at the Brain Tumor Research Center at the University of California, San Francisco, showed that Oncophage vaccination was associated with significant tumor-specific immune response in all 12 treated patients from baseline.
  2006
November Preliminary data from a Phase 1/2 investigator-sponsored trial of Oncophage as a treatment for recurrent glioma are presented at the Immunotherapy Task Force Meeting, held at the Society of Neuro-Oncology’s 11th Annual Scientific Meeting. Preliminary results from the first cohort of six patients in the study, being conducted at the Brain Tumor Research Center at the University of California, San Francisco, showed that vaccination was associated with tumor-specific immune response in all six treated patients.
October Antigenics announces the sale of $25 million of convertible senior notes to a group of accredited investors.
July Antigenics announces an expanded license and supply agreements for the use of QS-21 Stimulon® adjuvant with GlaxoSmithKline Biologicals, a vaccine division of GlaxoSmithKline (GSK). QS-21 is a key component included in several of GSK’s proprietary adjuvant systems. A number of GSK’s vaccine candidates currently under development are formulated with GSK’s proprietary adjuvant systems containing QS-21.
June Antigenics announces findings from an in-depth analysis of its Phase 3 study of Oncophage vaccine in kidney cancer. Review of the data at an international expert panel meeting on June 2, 2006, found that in the full analysis set, there was a clinically significant, 42-percent improvement in recurrence-free survival associated with Oncophage in a subgroup of earlier-stage (stages I and II) patients.
Antigenics announces in an oral presentation at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) updated findings from a Phase 3 clinical trial of Oncophage in metastatic melanoma. In the study, patients who received at least 10 doses of vaccine experienced an extension in median survival of 29 percent compared with those who received physician’s choice. In a subset analysis, Oncophage was associated with a potentially clinically relevant benefit compared with physician’s choice for patients with stages IV M1a and M1b melanoma, if at least 10 doses of vaccine were administered.
March Antigenics announces top-line results from its Phase 3 study of Oncophage in kidney cancer patients who are at high risk of recurrence after surgery. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s Clinical Events Committee revealed that a substantially smaller number of events had actually occurred. The preliminary analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint).
  2005
November The Brain Tumor Research Center at the University of California, San Francisco, initiates a Phase 1/2, investigator-sponsored clinical trial of Oncophage as a treatment for patients with recurrent glioma.
October Antigenics begins a Phase 1 trial of Aroplatin in solid tumors and B-cell lymphoma. Aroplatin, an investigational platinum agent, has been reformulated by Antigenics to enhance the drug’s activation and stability.

Antigenics initiates a Phase 1 trial of AG-707, an investigational vaccine designed to treat genital herpes.

Antigenics announces survival data from a preliminary analysis of the Phase 3 trial of Oncophage in metastatic melanoma. The study showed that in all randomized stage IV M1a patients median survival improved by more than 50 percent in the Oncophage-treated arm compared with those in the physician’s choice treatment arm. A final data analysis is expected during the first quarter of 2006.

June Antigenics announces that Oncophage® has been granted orphan drug status for the treatment of renal cell carcinoma by the European Medicines Agency (EMEA).
May A publication in Nature Immunology provides support for the immunological mechanism of action of the company’s heat shock protein (HSP)-based vaccines. The paper demonstrates that complexes of HSPs and peptides are the necessary and sufficient form of antigen to activate a killer T-cell immune response in vivo.
January Antigenics completes a private placement of convertible senior notes due 2025, raising net proceeds of approximately $48 million.
  2004
June Demographic data from the company’s Phase 3 trial of Oncophage in renal cell carcinoma, being conducted by The Antigenics Renal Cell Carcinoma Study Group, were published at the 40th annual meeting of the American Society of Clinical Oncology (ASCO). Also presented were immunological findings from a Phase 2 trial of combination treatment with Oncophage and cytokines in metastatic melanoma.
March Antigenics announces the sale of its manufacturing rights for feline leukemia virus vaccine to French veterinary pharmaceutical manufacturer Virbac S.A. for $14.25 million in cash.
January Antigenics completes $52.5 million public offering of common stock.
  2003
December An independent Data Monitoring Committee (DMC) convenes as scheduled for the interim analysis of the Phase 3 trial of Oncophage in renal cell carcinoma, and recommends that the trial proceed as planned. The DMC states that there is no need to change the patient accrual goals and declares the design and conduct of the trial sound.
  Data on heat shock protein-based vaccines were presented in a separate poster sessions at the 45th annual meeting of the American Society of Hematology. Preliminary findings from a Phase 1 study of HSPPC-70, an HSP70-based cancer vaccine, in chronic myelogenous leukemia and from a Phase 2 trial of Oncophage in non-Hodgkin’s lymphoma indicate that treatment with the HSP-based vaccines is well tolerated and feasible, and may be associated with clinical response.
November The US Food and Drug Administration lifts the partial clinical hold on Phase 3 clinical trials of Oncophage, and Antigenics resumes patient enrollment for the studies. The agency’s decision to lift the hold came 13 weeks after its request for product characterization information in September 2003.
October Antigenics publishes immunological results from Phase 2 trials evaluating Oncophage in the treatment of both advanced melanoma and colorectal cancer in the Journal of Immunology. Significant cancer-specific immune response among patients receiving Oncophage was observed, and the immunological mechanism of action was determined to be the same for both melanoma and colorectal cancer.
September The US Food and Drug Administration declares a partial clinical hold on Phase 3 clinical trials of Oncophage, stating product characterization issues needed to be more fully documented.
  Antigenics presented results from a Phase 1 trial of Oncophage in patients with nonmetastatic pancreatic cancer in an oral presentation at the annual European Cancer Conference (ECCO 12). Patients in the pilot study, which included 10 evaluable patients, experienced a median overall survival of 2.5 years, with one patient still alive and disease-free after five years, and two other patients alive and disease-free 2.1 years after treatment.
August Clinical Cancer Research published results from a Phase 2 trial of Oncophage for treatment of colorectal cancer as a featured article in the August 15 issue. In the study, more than half of the 29 patients who received Oncophage demonstrated significant immunological response - which not only appeared to be correlated with clinical response but also found to be an independent factor for prognosis.
June In an oral presentation at the 39th annual meeting of the American Society of Clinical Oncology (ASCO), Antigenics presented updated results from a pilot study of HSPPC-70, an HSP70-based cancer vaccine, in combination treatment of chronic myelogenous leukemia. Responses were observed in seven of the eight patients evaluated.
  Antigenics also presented at ASCO findings from two Phase 2 studies, which demonstrated that treatment with Oncophage was associated with clinical and immunological response in both kidney cancer and non-Hodgkin’s lymphoma.
April Antigenics initiates a large, multicenter Phase 2 trial of AG-858 in combination treatment for chronic myelogenous leukemia.
January Antigenics completes $62 million public offering of common stock.
  2002
December Antigenics reports significant results from a pilot study of HSPPC-70, an HSP70-based cancer vaccine, in combination treatment with Gleevec™ in chronic myelogenous leukemia patients.
October The Journal of Clinical Oncology publishes results from a Phase 2 trial of Oncophage in metastatic melanoma. In the study, Oncophage treatment was associated with both immunological and clinical response, and no treatment-related toxicity was observed.
July The US Food and Drug Administration (FDA) grants Oncophage orphan drug status in metastatic melanoma. The designation provides Antigenics with potential market exclusivity in metastatic melanoma for seven years from FDA marketing approval.
  Antigenics begins trial of Aroplatin monotherapy in metastatic colorectal cancer.
May Antigenics receives orphan drug status from the FDA for Oncophage in renal cell carcinoma, providing the company with potential market exclusivity for seven years from FDA marketing approval.
  Antigenics presents promising interim results from trials of Oncophage in metastatic melanoma, colorectal and gastric cancers at the annual ASCO scientific sessions.
  First patient is enrolled into Antigenics’ pivotal Phase 3 trial of Oncophage as a treatment for metastatic melanoma.
April Antigenics presents positive clinical and immunological data of Oncophage in melanoma and colorectal cancer at the annual meeting of the American Association for Cancer Research (AACR).
February Oncophage receives fast track designation from the FDA for treatment of metastatic melanoma. This is the second fast track designation for Oncophage, which previously received the designation as a treatment of renal cell carcinoma.
January Antigenics completes $60 million public offering of common stock.
  2001
October Oncophage becomes the first patient-specific cancer product to receive FDA fast track designation.
July Acquisition of Aronex Pharmaceuticals is completed.
  QS-21 adjuvant demonstrates a clinical response in Alzheimer’s disease, according to a study conducted by Elan Pharmaceuticals and American Home Products.
May Antigenics presents Oncophage data from melanoma and colorectal cancer clinical trials at ASCO.
February Antigenics launches Phase 1 study of AG-702 for genital herpes.
  2000
November Acquisition of Aquila Biopharmaceuticals is completed.
October Antigenics launches Phase 2 clinical trial of Oncophage for treatment of sarcoma at Memorial Sloan-Kettering Cancer Center.
June Antigenics launches first Phase 3 trial, a study of Oncophage in renal cell carcinoma.
May Antigenics presents results of clinical trials in renal cell carcinoma and gastric cancer at ASCO scientific sessions.
April Antigenics presents clinical data from Oncophage melanoma trial at the annual meeting of the American Association for Cancer Research.
March Antigenics launches Phase 2 clinical trial of Oncophage for the treatment of non-Hodgkin’s lymphoma.
February Antigenics raises $72.5 million in initial public offering of common stock.
  1999
November Antigenics raises $39.2 million in a round of private financing.
May Antigenics presents Oncophage data in renal cell carcinoma at ASCO annual meeting.
January Antigenics raises $27.6 million in round of private financing.
  1998
4Q Antigenics launches Phase 2 trial of Oncophage in melanoma and colorectal cancer in Milan.
  1997
November Phase 1 trial of Oncophage for treatment of pancreatic cancer commences at Memorial Sloan-Kettering Cancer Center.
  1996
December Antigenics raises $10.6 million in round of private financing.
November Investigational new drug application is filed with the FDA for Oncophage in cancer.
  1995
December Antigenics raises $1.5 million in round of private financing.
  1994
March Founding of Antigenics
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