Onyx regains certain ONYX-015 rights

ONXX regained full rights to its ONYX-015 adenoviral gene therapy to treat cancers by direct intratumoral injection or local or regional injections from partner Warner-Lambert, a division of Pfizer (PFE). Under the amended agreement, ONXX is responsible for all development and commercialization of the product for head and neck cancer, for which ONYX-015 is in Phase III testing. ONXX said that study has accrued only 5% of patients to date due to insufficient supply of ONYX-015 and the small number of clinical trial sites. ONXX said the slow accrual could delay a BLA filing by six months or more.

PFE will retain rights to develop ONYX-015 for intravenous (IV) treatment of cancers. If PFE receives FDA approval for IV ONYX-015, the companies will resume the original collaboration under the terms of the 1999 agreement, which provides ONXX with responsibility for 25% of clinical trials costs and with up to $100 million in research, clinical and regulatory milestones (see BioCentury, Oct. 25, 1999). However, ONXX also said that all ongoing IV trials of ONYX-015 have been discontinued and that the first supply of product from Xoma (XOMA), which is beginning production of ONYX-015 using a 500 L bioreactor, is expected in the first quarter of 2002. ...