Washington Editor

Argos Therapeutics has raised $35.2 million in a Series C financing to support Phase II clinical trials of its renal cell carcinoma and HIV candidates, which uses the company's RNA-loaded dendritic cell-based immunotherapy technology, known as Arcelis.

The financing also will support the advancement of the Durham, N.C.-based firm's CD83 protein immunology program through an initial human clinical trial in transplantation, said CEO John Bonfiglio.

Argos, which changed its name in 2004 from Merix Bioscience, has initiated a Phase II clinical trial of AGS-004 in patients with HIV infection.

That trial is expected to enroll about 34 patients, Bonfiglio told BioWorld Today.

The firm also has started enrolling patients with renal cell carcinoma testing the efficacy of its lead Arcelis cell therapy product AGS-003.

The first renal cell study will evaluate the drug as a standalone therapy initially in 18 patients, with the potential to add an additional 18, Bonfiglio said.

A second study will test the efficacy of AGS-003 in combination with Pfizer Inc.'s chemotherapy agent Sutent (sunitinib malate) in 36 patients, he added. Data from a Phase IIa trial of AGS-003 showed a median survival similar to that of Sutent and other drugs, Bonfiglio said.

Tokyo-based Kirin Pharma Co. Ltd., a division of the Japanese beer maker Kirin Brewery, is covering half of the development costs of Argos' Arcelis program under a 2004 deal, Bonfiglio noted. Under the terms of the deal, the firms will equally share any worldwide profits from any products that gain approval and are commercialized, he added.

Argos' Arcelis technology works by triggering an immune system response directed at the disease, Bonfiglio explained. The firm extracts the RNA from a patient's tumor or blood sample, which is then amplified. The RNA is placed into dendritic cells, which the firm uses to make its personalized injectable product.

"So from the doctors' perspective, all they have to collect is a blood sample for us or a tumor sample, and then they have to do a small leukopherisis product of these patients, and then we give them back a product that they just have to inject directly into the patients," Bonfiglio said.

Safety studies have shown adverse effects to be mild, such as irritation around the injection site or minor flu-like symptoms, he said.

"If this works, it's going to be a much nicer way of treating the disease," Bonfiglio said. "It's also using the body's own immune system to fight the tumor or the infection," he added.

Argos expects to have data available from its Phase II studies of AGS-003 and AGS-004 by mid- to late 2009, Bonfiglio said.

He noted that the National Institutes of Health awarded the firm a $21 million contract to develop a "next-generation HIV product" based on Argos' Arcelis platform.

"A lot of people believe in what we are doing right now," he said.

Bonfiglio predicted that cell therapies will burst into the marketplace much the same way that antibodies did in recent years, creating a multibillion market.

"Between now and the end of '09, there are a lot of cell therapy companies that will be reporting on data from clinical trials, and I think if any one of them are successful, it's going to change the entire market perception of the technology," Bonfiglio declared.

He said his firm also has received a lot of attention from big pharma companies about potential licensing deals for its transplant antirejection product CD83, which currently is being tested in animal studies.

"The incredible thing about this therapy is that it doesn't require chronic administration," he noted. "With this therapy, we so far have been able to dose the animals right before the transplant and then just directly after for a few doses and then stop, and the animal doesn't reject the organ, which is amazing," he added.

Argos' Series C financing was led by TVM Capital and included participation from new investors Mizuho Capital, Morningside Group and Japan Asia Investment Co. Existing Argos investors Lumira Capital, Forbion Capital Partners, CDP Capital, Intersouth Partners, Aurora Capital and GeneChem also participated in the round. Kirin Pharma Co. Ltd., which has an ongoing worldwide collaboration with Argos, also participated.

In other financings news:

• Aldagen Inc., of Durham, N.C. raised $18.4 million in a private round of financing to further advance the development of its four clinical-stage product candidates and for general corporate purposes. The financing was obtained from existing investors, including Intersouth Partners, Tullis-Dickerson, Harbert Venture Partners and the Aurora Funds.

• Champions Biotechnology Inc., of Arlington, Va., completed a $2.5 million private financing. Under the terms of the private investment, Champions issued 1.4 million restricted shares of common stock at $1.75 per share. There were no fees or other expenses related to the funding.