Avigen is a competitor in the AAV gene therapy field to NIBM Model Portfolio member Targeted Genetics (TGEN). Avigen began human clinical trials on Coagulin-B, its treatment for Hemophilia-B and had to halt those trials when the first and only receipient of Coagulin-B was shown to have the AAV vector in his seminal fluid. Such an indication was predetermined to be a halting point for the study and a trigger for an assesment as to whether the AAV vector and gene therapy package it carried could then be communicated to a sexual partner.

Biotech IPOs lead the way back

When Given Imaging's (GIVN) IPO went to market on October 4th, the maker of a device to wirelessly scan the intestines broke a seven-week IPO drought. Given went IPO at $12 and closed the day at $12.47. It has since pulled back sharply to near $9.

The next IPO out of the gate was Therasense (THER), a biomedical test kit company. Therasense was a huge hit with investors, climbing 32% over its offering price of $19/share. The company was lately trading at $24.99, slightly above its first-day close. The opening day pop was good enough to place it 3rd on the list of 2001 first day IPO gainers.

Late October and early November is expected to be flush with biotech IPOs and secondary financings. Sometimes this puts a damper on overall sector performance but with the enormous amount of money on the sidelines and continued evidence of rotation from bonds into equities we expect there to be enough liquidity to handle the additional supply.

Antigenics (AGEN) cancer vaccine Fast Tracked

Antigenics announced on 10/15 its autologus cancer vaccine product Oncophage was given Fast Track status by the FDA, making it eligible for a six-month approval process compared to the 12-18 months that is normal. Oncophage is still in Phase III trials for kidney cancer and expects to submit to the FDA for approval near the end of 2003.

The company asserts this is the first fast track designation for what it calls "personalized vaccines." This method requires a surgical biopsy of the tumor, the biopsy to be sent to the company's operations center, the biopsy be processed into the vaccine, the vaccine sent back to the treating physician, and then administered to the patient. There are several companies working on similar vaccine processes but the scientific and operational hurdles are complex.

NIBM Model Portfolio member Dendreon (DNDN) uses what we call a semi-autologus method for their Provenge and Mylovenge candidates where only blood products are required from the patient (specifically, white blood cells). Dendreon expects to submit Provenge for FDA approval in 2002 and may well be the first cancer vaccine on the market. Dendreon is the subject of the main story in November issue of the NIBM Newsletter.

(One or more NIBM staff members or research partners owns a long position in DNDN. For more details on our industry-best disclosure policy, visit the "Disclosures" section of the BiotechMonthly.com web site.)