Antigenics' Pipeline Looks Like a No-Go

In Antigenics' first-quarter conference call, the company stated that it plans to test vaccine vials from its phase III part I renal cell carcinoma trial retrospectively to determine whether it can prove that the vaccines were in fact well-characterized -- a general regulatory requirement that means the product components and their amounts are known -- during the trial. After meetings with the FDA during 2004, Antigenics was informed that submission of data from its phase III part I renal cell carcinoma trial would be insufficient to support a BLA and the company initiated a phase III part II clinical trial in renal cell carcinoma in February 2005.

Currently, Antigenics expects that the final analysis of its phase III part I clinical trial in renal cell carcinoma could be triggered in August or September 2005, and that within six weeks the company would be able to make public disclosures. After the final data analysis, Antigenics' management stated that it will decide whether or not to file with regulatory authorities in the U.S., Canada and Europe for Oncophage treatment of post-operative renal cell carcinoma patients (adjuvant therapy indication).

Antigenics ended the first quarter with $114 million in cash and cash equivalents after its private placement in January 2005. Management stated that launch plans are under way for Oncophage. If the company does file for an Oncophage biologics license in the U.S., Canada and/or Europe, the best chances for product acceptance will be in Europe, where regulations regarding the use of personalized therapies differ substantially from those in the U.S.

Should Antigenics pursue a regulatory filing in Europe, Oncophage may be challenging another autologous cancer vaccine, Reniale, which LipoNova GmbH anticipates launching in early 2006 for renal cell carcinoma. In addition to facing competition, Antigenics will face a fragmented market compared with that of the U.S., along with more restrictive reimbursement pressures in Europe that often require substantial discounting.

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