| |
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-Hodgkins 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 agencys 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 Alzheimers 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-Hodgkins 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 |