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Antigenics Presents Positive Phase II Data on Oncophage Cancer Vaccine at ASCO Annual Meeting
June 2, 2003
Chicago, Illinois



Clinical and Immunological Responses Observed in Kidney Cancer and Lymphoma
Oncophage Data In Addition to AG-858 Data in CML Presented Yesterday at ASCO

 

Antigenics Inc. today announced interim results from four clinical trials, including two Phase II studies demonstrating that treatment with the company's Oncophage® (HSPPC-96) cancer vaccine was associated with clinical and immunological response in both renal cell carcinoma and non-Hodgkin's lymphoma.

The findings were presented in poster sessions at the 39th annual meeting of the American Society of Clinical Oncology (ASCO).

"These data provide further support for the use of Oncophage in a wide range of cancers, either as a single agent or in combination with other treatment modalities," said Jonathan J. Lewis, MD, PhD, chief medical officer of Antigenics. "As we continue to advance the development of Oncophage, we're increasingly encouraged by the consistency of the clinical findings and hope that we will soon be able to offer a new treatment option for both physicians and patients."

Oncophage, Antigenics' lead product, is a personalized cancer vaccine based on the company's proprietary heat shock protein technology. Derived from each patient's cancerous tissue or cells, the vaccine is designed to capture the 'antigenic fingerprint' of the patient's particular cancer to reprogram the body's immune system to target and destroy only the cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and prevent the debilitating side effects associated with traditional cancer treatments such as chemotherapy and radiation therapy. It is currently being evaluated in pivotal Phase III studies for the treatment of renal cell carcinoma and metastatic melanoma; other clinical research evaluating Oncophage includes studies in several cancers such as lymphoma, colorectal, pancreatic and stomach cancers.

Promising Data in Multiple Disease Areas

The first study presented at the ASCO annual meeting evaluated the efficacy and safety of Oncophage vaccination in 10 patients with newly diagnosed or relapsed low-grade, indolent (slow-growing) non-Hodgkin's lymphoma (abstract #2294). Among the 10 patients who received Oncophage in the Phase II trial, there were responses observed in six: one partial response, two minor responses and three disease stabilizations. Researchers observed that all responding patients were either previously untreated or received only one prior treatment regimen, suggesting the potential utility of the vaccine in patients with minimal residual disease. Oncophage was well tolerated, with no adverse effects, and researchers concluded that Oncophage treatment is feasible, safe and may be effective in patients with low-grade lymphoma.

Also presented at the meeting were findings from a second Phase II trial in which researchers evaluated the efficacy and safety of Oncophage alone or in combination treatment in 61 patients with metastatic renal cell carcinoma, or kidney cancer (abstract #1552). Treatment consisted of Oncophage vaccination (one injection weekly for four weeks, followed by one injection every other week until depletion of vaccine supply); patients whose cancers progressed during Oncophage vaccination also received immunotherapy with interleukin 2 (IL-2, an immune system regulator).

Of the 61 patients who received at least one dose of vaccine, 21 patients responded clinically, including one patient who remains completely free of disease more than 2.5 years after treatment. Of the 16 patients whose disease progressed while on vaccine, seven achieved disease stability after addition of IL-2. Median progression-free survival was 18 weeks for all patients who received Oncophage, and 25 weeks for patients who also received IL-2. Two years after initiation of the vaccine, 30 percent of all patients remain alive. No significant toxicity was observed to be associated with Oncophage treatment. Researchers concluded that vaccine therapy demonstrated encouraging clinical efficacy, appearing to confer disease stability as a single agent as well as a favorable median progression-free survival compared with other, more toxic treatments.

Antigenics also presented clinical findings from two clinical trials conducted at Memorial Sloan-Kettering Cancer Center evaluating cancer vaccines containing Antigenics' QS-21 immune stimulant. The first evaluated immune response to a QS-21-containing breast cancer vaccine that contained seven different antigens in 10 patients with stage II or stage IV disease. Results showed that two of the antigens, MUC1 and TF(c), appeared most immunogenic (abstract #675) and stimulated the highest levels of specific antibody production.

Similarly, the last trial studied immunologic response to a multi-antigen, QS-21-containing vaccine in prostate cancer patients with high risk biochemically relapsed prostate cancer, defined as relapse within two years of primary therapy of prostate-specific antigen (PSA), increased levels of which may indicate prostate cancer (abstract #671). Of the 14 patients who received one course of vaccination (eight vaccines), two achieved significant reductions in PSA levels, and two patients' PSA levels remained stable. Researchers concluded that using chemotherapy or other treatment modalities prior to vaccination may be a reasonable strategy that warrants further exploration.

In an oral presentation yesterday, Antigenics also announced updated results from an ongoing pilot study of its AG-858 cancer vaccine in combination with Gleevec(TM) (imatinib mesylate, Novartis) for treatment of chronic myelogenous leukemia (CML). The study findings demonstrated responses in seven of the eight patients evaluated. Furthermore, immunological analysis indicated that vaccination with AG-858 was associated with an increased production of interferon gamma -- an indication of activation of T cells, a specialized type of immune system cell crucial in fighting cancers and infections.

About Antigenics

Antigenics is working to develop personalized immunotherapeutics and revolutionary treatments for cancers, infectious diseases and autoimmune disorders. The company's lead product candidate is Oncophage, a late-stage, personalized cancer vaccine being evaluated in several indications, including kidney cancer and metastatic melanoma. Antigenics' portfolio also includes AG-858, a personalized cancer vaccine in Phase II development; Aroplatin and ATRA-IV, two Phase II liposomal chemotherapeutics; and AG-702/AG-70X, a Phase I genital herpes immunotherapeutic. For more information about Antigenics, please visit www.antigenics.com.

This press release contains forward-looking statements, including the statements regarding the use of Oncophage in a wide range of cancers, either as a single agent or in combination with other treatments; the possibility of being able to offer new treatment options; the utility of Oncophage in patients with minimal residual disease renal cell carcinoma, and its feasibility, safety and efficacy in patients with low-grade non-Hodgkin's lymphoma; and the use of other treatment modalities prior to vaccination. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, that we may not be able to enroll sufficient numbers of patients in clinical trials to demonstrate statistically significant results; that we may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market our products; that budget constraints will limit or slow down our development programs; that we may fail to adequately protect our intellectual property or are determined to infringe on the intellectual property of others; and the factors described in the company's periodic filings with the Securities and Exchange Commission. Please see Exhibit 99.1 of the Antigenics Quarterly Report on Form 10-Q for the quarter ending March 31, 2003, for a full discussion of these and other risk factors. Antigenics cautions investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

 

 

Press Release
SOURCE: Antigenics Inc.

 
 


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