Shares of biotech startup Antigenics Inc. (AGEN), which were trading around $0.50 till May, have quadrupled since then following the release of positive interim data of its kidney cancer vaccine Oncophage and the looming EMEA regulatory decision.
Oncophage is a revolutionary patient-specific therapeutic vaccine designed to treat cancer with minimal side effects, according to the company. As mentioned, the vaccine is patient specific because it is made from individual patients' tumors.
Oncophage was approved in Russia in April 2008 for the adjuvant treatment of kidney cancer patients at intermediate risk of relapse after kidney cancer surgery. The vaccine's approval in Russia was based on a subset of data from a phase III study, which demonstrated a 45% improvement in recurrence-free survival associated with Oncophage in patients with intermediate-risk kidney cancer, although a significant improvement was not observed in the overall patient population.
The interim survival data presented in June 2009 showed that Oncophage appeared to lower the risk of death by almost 46% in the intermediate-risk kidney cancer patient population. Final results are expected in 2010.
Since Oncophage failed to meet the primary trial goal of increasing the duration of recurrence-free survival of kidney cancer patients at high risk of relapse in the late-stage study and a subset analysis data is not considered by the FDA, unless a new phase III trial is conducted, analysts are of the view that approval in the U.S. might be delayed.
In October 2008, Antigenics sought approval of the EMEA for Oncophage in earlier-stage, localized kidney cancer under the conditional authorization provision. The company expects a decision from the EMEA around the end of 2009.
Pre-commercial launch activities of Oncophage in Russia are ongoing and the vaccine is projected to generate $100 million in sales for the company.
Oncophage has also been studied in phase III trial for metastatic melanoma and is currently being investigated in a phase II trial in recurrent glioma, a type of brain cancer. The phase II glioma study is expected to complete enrollment by late 2009 and data will be submitted for publication and presentation in early 2010.
Antigenics is more than just the cancer vaccine. The company is also developing an adjuvant -- QS-21, which is a substance added to vaccines, to enhance the body's immune response. QS-21 is currently being evaluated in clinical trials in a variety of disease areas like melanoma, malaria HIV, influenza and other infectious diseases by Antigenics' corporate partners -- GlaxoSmithKline, Wyeth-Lederle Vaccines, Aventis Pasteur, Acambis, Progenics Pharmaceuticals and Elan Corp. In return for rights to use QS-21, Antigenics is paid license fees, manufacturing payments, milestone payments, and royalties on product sales for a minimum of 10 years after commercial launch by its corporate partners.
According to the company, QS-21 is currently being evaluated in about 20 vaccine indications, of which several are in late-stage clinical trials by its licensees, including GlaxoSmithKline and Elan. If successful, Antigenics believes that its commercial licensees and collaborators could launch their products beginning as early as 2010, which in turn would bring in annual royalties in hundreds of millions.
Last month, GlaxoSmithKline launched a phase III study with the world's most clinically-advanced malaria vaccine, RTS,S, which contains Antigenics' QS-21 Stimulon adjuvant.
Antigenics has incurred significant losses since its inception in March 1994. The company's fiscal year ends on December 31. As of March 31, 2009, the company had an accumulated deficit of $541.7 million. For the first-quarter ended March 31, 2009 net loss attributable to stockholders narrowed to $9.67 million or $0.14 per share from $11.57 million or $0.21 per share in the year-ago quarter. Quarterly revenues declined to $621 thousand from $850 thousand in the comparable quarter a year before. The company is slated to report its second-quarter results on July 30.
AGEN, which has thus far hit a 52-week low of $0.19 and 52-week high of $3.34, closed Wednesday's trade at $2.12.
The upcoming EMEA decision on Oncophage could have a major impact on Antigenic's stock price. Will it pass the regulatory muster? Stay tuned...
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