West Coast Editor

With excitement high around its Phase III lead product for cancer, Genitope Corp. is hauling down another $53.7 million in a sale of 4 million shares at $14.25 per share.

The company's stock (NASDAQ:GTOP) closed Tuesday at $15.01, down 19 cents.

Over the summer, Redwood City, Calif.-based Genitope sold about 7 million shares, including 914,823 shares as part of an overallotment option granted to the underwriters, at $8.50 apiece for net proceeds of about $55.5 million. (See BioWorld Today, May 28, 2004.)

As of Sept. 30, the company had about $38.8 million in cash and cash equivalents, with a net loss for the nine months ending that date of about $20.1 million.

John Vuko, vice president and chief financial officer of Genitope, said the company would not discuss the financing until the transaction closes.

Its lead candidate is MyVax Personalized Immunotherapy, a patient-specific approach based on the genetic makeup of an individual patient's tumor and designed to make the immune system attack cancer cells. MyVax combines a protein derived from the patient's own tumor with an immunologic carrier protein and is administered with an immunologic adjuvant.

Last month, an independent Data Safety Monitoring Board noted no concerns in the pivotal Phase III trial testing MyVax therapy in patients with previously untreated follicular non-Hodgkin's lymphoma. The DSMB reviewed safety data for the entire Phase III trial and blinded preliminary immune response data for more than 100 of the initial patients. Genitope said it expects to conduct the first interim analysis of the data in the second quarter.

Meanwhile, cash from the latest stock sale will fund leasing, build-out and qualification of a commercial-scale manufacturing facility, as well as manufacturing and potential commercialization expenses, clinical trials and research. Sales and marketing are other uses, along with general corporate purposes.

The company has its own manufacturing process that deploys its Hi-GET technology, a method of gene amplification divided into three phases: molecular biology, cell culture and production. With MyVax, the patient's tumor sample is collected in a routine biopsy, shipped overnight to the manufacturing facility and then shipped back to the physician after processing.

Genitope has managed to reap financings despite a rather crowded NHL market. There's Rituxan (rituximab), a monoclonal antibody co-marketed by South San Francisco-based Genentech Inc. and Biogen Idec Inc., of Cambridge, Mass., for relapsed or refractory, low grade B-cell NHL.

Biogen Idec also has the passive radioimmunotherapy product, Zevalin (ibritumomab tiuxetan), and the FDA recently approved Bexxar (tositumomab and iodine I-131 tositumomab) from London-based GlaxoSmithKline plc and Corixa Corp., of Seattle, for relapsed or refractory, low grade, follicular, or transformed B-cell NHL. Corixa disclosed Tuesday that it had sold all Bexxar rights to partner GSK.

WR Hambrecht + Co. in New York, which initiated coverage of Genitope with a "buy" rating at the start of the year, reiterated the rating last month. Hambrecht has a $25 price target on the stock.

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