National Editor
About one month after saying it would suspend recruitment in a Phase III trial of its lead prostate cancer drug, sell some fixed assets and consider other options for the future, Northwest Biotherapeutics Inc. has made more cuts and may shut down entirely.
Bothell, Wash.-based NBI, with only $2.9 million in cash, has suspended all clinical trial activity for its line of DCVax product candidates, including the prostate cancer drug, and has withdrawn its investigational new drug application for it and for DCVax-Lung, a potential treatment for non-small-cell lung cancer. Although the company has clearance to start a Phase II trial of DCVax-Brain for glioblastoma multiforme, that work can't go ahead without more money.
The public relations firm for NBI, Apco Worldwide, did not return phone calls seeking comment. NBI said earlier that it had enlisted C.E. Unterberg, Towbin to help sort its options for the future. Unterberg, Towbin did not return calls.
NBI's stock (NASDAQ:NWBT) closed Friday at 16 cents, down 2 cents, or 11.1 percent.
NBI said goodbye to 10 staff members last month and expects to part ways with 20 more by the end of the year. Among the positions eliminated are those of chief financial officer and chief medical officer, but the company said it still has adequate staff to operate with a focus on preclinical antibody and dendritic cell development - but only if a key condition is met.
The key to survival is NBI's deal with an unnamed "third party" to sell certain rights, title and interest in several antigen targets pertaining to its monoclonal antibody program. The deal can be canceled by the other party but, if it goes through, payments from it would let NBI continue as an entity of about 14 employees. Of the $2.9 million of NBI's cash, $500,000 is a non-refundable payment associated with that deal.
That antigen-target deal also would obligate NBI to repurchase rights to several of the targets from the other party in exchange for newly issued stock and warrants, a move that would be dilutive to NBI - but without more payments from the deal, the company said it is finished and will sell all tangible and intangible assets by the end of the year.
The news comes two weeks after NBI's main competitor in dendritic cell research against prostate cancer, Seattle-based Dendreon Corp., was given FDA clearance to resume Phase III trials of Provenge, its therapeutic vaccine for hormone-resistant prostate cancer.
This spring, the agency forced Dendreon to suspend new enrollment pending submission of information referencing the manufacture and characterization of Provenge. However, the 100 or so patients enrolled at the time of suspension were allowed to continue. (See BioWorld Today, Oct, 29, 2002, and May 2, 2002.)