Antigenics, Inc.

 

 

630 Fifth Avenue
Suite 2100
New York, NY 10111

USA

T: 212.994.8200

F: 212.994.8299

Email:

Web site: www.antigenics.com

 

A. Company Profile

 

Antigenics, Inc. (NASDAQ:AGEN) develops products for the treatment of cancers through its discovery research programs. The company is pioneer in the area of personalized cancer vaccines based on the heat shock protein (HSP) technology. The Company's products are designed to improve on conventional treatments by prolonging survival, reducing side effects, and enhancing quality of life.

 

B. Technology

 

HSPs are so named because their presences are significantly increased when cells are exposed to various types of environmental stresses, such as heat. HSPs are present in cells under normal conditions and are classified into a series of families, such as HSP60, 70, and 96, based on their molecular mass in kilodaltons. They act like 'chaperones' making sure that the cell's proteins are in the right shape and in the right place at the right time. HSPs are also believed to play a role in the presentation of pieces of proteins (or peptides) on the cell surface to help the immune system recognize diseased cells. These peptides are called antigens - a term that describes any substance capable of triggering an immune response. HSP technology works by generating HSP-peptide complexes that have been isolated from individual patient's cancer cells. The HSP-peptide contains unique profile of signals or the antigenic fingerprint of the patent's cancer. These unique signals have the capacity to activate the immune system to elicit a powerful anti-tumor response.

 

C. Products

 

 

Product Pipelines

 

Product	Indication	Clinical Status
AG-858 Plus Gleevec	Chronic myelonic leukemia	Phase II
Oncophage	Kidney cancer	Phase III
	Melanoma	Phase III
	Colorectal cancer	Phase II
	Lymphoma	Phase I
	Pancreatic cancer	Phase I

 

1. AG-858

 

AG-858 is an investigational personalized vaccine designed to treat cancer while minimizing side effects that are often associated with other treatment options. AG-858 is based on HSP70.

 

(1) Procedure of Generating the Products

 

AG-858 is a vaccine made from individual patients' cancerous cells. Patients undergo a blood filtering process called leukapheresis, during which white blood cells are collected. The white blood cells are sent to manufacturing facilities so that the presonalized vaccines can be made. Using a standardized quality-controlled process, heat shock proteins and their associated peptides are isolated from the cells and made into an injectable vaccine.

 

(2) Clinical Trials

 

AG-858 is currently being evaluated in combination treatment for chronic myelogenous leukemia (CML). Interim results from an ongoing pilot study indicate that combination treatment of CML with AG-858 and Gleevec[TM] (imatinib mesylate, Novartis) was associated with objective clinical responses in five out of the five evaluable patients in the trial - including two patients who had complete molecular responses. Based on these encouraging data, Antigenics plans to initiate a Phase II study

 

To minimize disruption to the patient's everyday life, AG-858 treatment is administered on an outpatient basis over the course of several weeks.

 

2. Oncophage

 

Oncophage, also known as HSP peptide complexes (HSPPC)-96, an investigational personalized vaccine designed to treat cancer while minimizing side effects. Treatment with Oncophage is intended to target only cancerous cells, potentially improving clinical response and prolonging survival without serious adverse effects or disruption of quality of life.

 

(1) Procedure of Generating the Products

Oncophage is a vaccine made from individual patients' tumors. Patients have surgery to remove part or all of the cancerous tissue, and a portion of this tissue is shipped overnight to the manufacturing facilities. Using a proprietary manufacturing process, HSP-peptide complexes are extracted and purified from each sample, then sterilely filtered and placed into vials. The final product is subject to extensive quality-control testing, including sterility testing of each lot. The vaccine is shipped frozen back to the hospital for use when the patient has recovered from surgery.

 

(2) Clinical Trials

More than 450 cancer patients in 13 clinical trials around the world have been treated with Oncophage. Many of these patients had advanced disease that had not responded to traditional cancer treatments, including kidney cancer, melanoma and colon cancer

 

Oncophage is currently being evaluated in Phase III clinical trials in kidney cancer and metastatic melanoma - the two indications for which Oncophage has been granted fast track designation by the US Food and Drug Administration. Products are designated as fast track when they are intended to treat a serious medical condition and have the potential to address an unmet medical need. The product may be applicable to the treatment of all cancer types.

 

Oncophage treatment begins after the patient has recovered from surgery (usually within four to eight weeks). The patient receives one injection of the personalized Oncophage vaccine once a week for four weeks, then one Oncophage injection every other week until the supply is depleted. Oncophage treatment is designed to be given on an outpatient basis to minimize disruption of the patient's everyday life.

(3) The Side Effects

Since Oncophage is derived from patient's own tissue, side effects are extremely minimal. A very small percentage of the patients who have received Oncophage (less than 5 percent) experienced flu-like symptoms such as fever, headache and weakness. Other, less common side effects include rash, muscle pain and skin tingling.

 

D. Job Opportunities at Antigenics

 

E. Information for Investor

 

F. Others