By Debbie Strickland
Portland, Ore.-based AntiVirals Inc., which just went public this year, is changing its name to AVI Biopharma Inc. and injecting a late-stage product into its pipeline by agreeing to purchase for $24 million ImmunoTherapy Corp. (ITC), a privately held, Seattle-based cancer vaccine specialist.
The name change takes effect immediately, and the acquisition is expected to close by year end. Shares in AVI will trade on the Nasdaq National Market under AntiVirals' former symbol, AVII.
AntiVirals' contributions to the new company include a product development pipeline, the company's status as a publicly traded firm with access to capital, a full management team — and the $24 million purchase price for ITC, to be paid in stock and warrants.
ITC's dowry in this marriage is its lead drug, CTP-37, a synthetic peptide conjugate vaccine designed to fight cancer by turning the immune system against cells that carry a hormone common to many tumor types: the human chorionic gonadotropin (hCG) hormone, which boosts growth and shields cells from immune system attack.
Produced naturally during pregnancy, hCG protects the growing fetus from immune system rejection. The hormone hangs a similar "do not disturb" sign on cancerous cells, and is found in highest concentration among the most aggressive cancers.
CTP-37, renamed Avicine in conjunction with the merger, has reached the Phase III threshold, having "demonstrated objective antitumor activity and apparent survival benefits in all studies to date," according to the companies.
Avicine is in Phase II multicenter clinical studies for colorectal and pancreatic cancers. AVI expects to begin Phase III studies in at least one cancer indication — perhaps colorectal — in early 1998. Phase II studies for the treatment of metastatic breast and prostate cancer are also planned for early 1998. To date, more than 125 patients have been treated with Avicine.
In trials, the drug has elicited specific immune responses to hCG in most patients and, according to Phase II data in colorectal cancer, appears to provide survival benefits in patients who show immune responses to vaccination by the third month of therapy. Detailed trial results were unavailable, pending submission to the FDA.
"This is eminently approvable and essentially non-toxic," said Denis Burger, president and CEO of AntiVirals. "By adding this new technology into the mix, we accelerate to late-stage clinical development, and we have a much more comprehensive, extensive program in cancer."
Hence, the name change to AVI Biopharma, which, Burger said, better reflects the new company's focus on cancer and cardiovascular therapies. Burger will remain president and CEO of AVI.
Acquisition plans call for consolidation of AVI Biopharma at AntiVirals' facilities, he said. ITC has about a half-dozen employees, and "one or more" are expected to join AVI as the company expands to accomodate the march into clinical-stage development. Jeffrey Lillard, managing director and founder of ITC, will be appointed vice president and serve on AVI BioPharma's board of directors.
A contract research organization will likely conduct the Avicine Phase III trials. Burger expects that, in keeping with AntiVirals' existing business plan, strategic partnering deals will handle sales and marketing if the product is approved. Negotiations are under way with prospective Avicine collaborators.
Early-Stage Drugs Include Antisense
The earlier end of AVI's pipeline is stocked with drugs from the AntiVirals portfolio, which is centered on two technologies, Neu-Genes and CytoPorter. The company is targeting 1998 for the initiation of trials of the lead product from each program.
Neu-Genes antisense compounds are designed to block specific messenger RNA molecules, shutting down a targeted gene's production of a disease-causing protein. The most advanced preclinical Neu-Gene drug candidate is a treatment for the cardiovascular disease restenosis.
A drug delivery system, Cytoporter is designed for use with antisense and other drugs. The technology enables therapeutic molecules to slip through the lipid barrier of cellular membranes to get to the interior of cells. The company has coupled Cytoporter with paclitaxel, an anticancer drug, and cyclosporin, an immune system suppressent, with the paclitaxel-Cytoporter combination emerging as the lead product.
Both paclitaxel and cyclosporin are FDA-approved already.
As of Sept. 30, AntiVirals had $18 million in cash, following a net loss of $2.8 million over the first nine months of 1997. The company conducted its initial public offering this June, grossing $21 million and netting $19 million. (See BioWorld Today, June 5, 1997, p. 1.)
AntiVirals shares (NASDAQ:AVII) closed Thursday at $9.125, down $0.187. *