The CEO's Blog — Garo H. Armen
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QS-21 and Oncophage®
Following Antigenics’ recent announcement that GlaxoSmithKline is launching a Phase 3 study in lung cancer evaluating its MAGE-A3 therapeutic cancer vaccine, GSK stated on Monday 18th June during a GSK oncology seminar that the first patient is expected to enroll in September.
How does this benefit Antigenics? This represents one of more than 20 QS-21 containing vaccines currently in development by Antigenics’ licensees. Currently a profitable product, our license and supply agreements for QS-21 provide revenues for Antigenics and royalties post-commercial launch for at least 10 years thereafter, irrespective of patent expiries. Therefore, GSK’s new Phase 3 trial – the largest lung cancer trial ever conducted, enrolling 2,270 patients at 400 centers in 37 countries – could generate additional royalties for Antigenics in a near-term timeframe.
On a related note, in addition to providing information surrounding enrollment activities, what I also found particularly encouraging at the oncology seminar were public comments made by GSK’s investigators supporting the use of cancer vaccines in earlier-stage patients. Professor Johan Vansteenkiste at Belgium’s Catholic University Leuven stated that: “immunotherapeutics are most likely to be successful in patients with small amounts of disease … (and) unlikely to be successful against large tumors.” This is not only right in line with the substantive preclinical and clinical evidence and a growing consensus from key experts that cancer vaccines work best in earlier-stage patients – it’s also right in line with our own results of Oncophage in kidney cancer.
When we presented an additional 17 months of follow-up data from our Phase 3 kidney cancer trial at the American Urological Association meeting in May, Oncophage vaccine was associated with a clinically and statistically significant improvement in recurrence-free survival in earlier-stage, intermediate-risk patients. In this group of 362 patients, we demonstrated that Oncophage improved recurrence-free survival in earlier-stage patients by 45 percent. Similarly, GSK’s presentation at the American Society of Clinical Oncology meeting this month also showed encouraging results among earlier-stage cancer patients. In a Phase 2 trial, among a group of 182 earlier-stage non-small cell lung cancer patients, GSK’s MAGE-A3 vaccine reduced relapse risk by 27 percent.
Despite the challenges associated with subset analysis, we are actively pursuing registration of Oncophage based on our promising findings in intermediate-risk kidney cancer patients. Innovative ex-US regulatory programs around the world, including those in Russia, Canada and Europe, may help bring Oncophage to the patients who are likely to benefit the most.
Please don’t hesitate to be in touch with us with your questions and comments, as we take them seriously and enjoy hearing from you always.
This communication contains forward-looking statements, including statements regarding the future Phase 3 clinical trial in lung cancer using QS-21 by GSK, the future development of products using QS-21, the future payment of milestone payments and royalties in connection with the development and commercialization of QS-21, the potential clinical benefit of Oncophage in kidney cancer based on a subgroup analysis; and potential strategies for pursuing the registration of Oncophage. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, Antigenics’ dependence on its collaborative partners such as GSK to successfully develop and commercialize products containing QS-21, the scientific risk associated with the development of vaccines, the competitive risk that other sources of competitive adjuvants could become available, and difficulties or delays in manufacturing QS-21; retention of key employees; the risk that future survival data from patient monitoring may not support further development or registration of Oncophage; decisions by regulatory agencies; the ability to raise capital and finance future development of Oncophage; and the factors described under Factors That May Impact Future Results in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics’ Form 10-Q as filed with the Securities and Exchange Commission on May 10, 2007. Antigenics cautions investors not to place considerable 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. Antigenics’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics’ business and securities, investors should give careful consideration to these risks and uncertainties.
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