Immunotherapy company Argos Therapeutics has developed a new technology that could set it apart from other biotechnology cancer treatments — an approach that’s completely personalized to the patient and also costs less. But that’s just the beginning. This personalized medicine platform technology is also being developed to treat other diseases such as HIV.
With positive phase 2 clinical trial results in hand, Durham, North Carolina-based Argos is now preparing to take its technology into late-stage trials for treating kidney cancer, for which the company will need an estimated $50 million in new financing. But a large pharmaceutical company could foot the bill instead. CEO Jeff Abbey said Argos is talking with pharmas interested in partnering with the company to study, develop and ultimately commercialize the technology.
Immunotherapy induces a patient’s own immune system to fight disease. Argo’s technology, called Arcelis, works by taking the RNA from the patient’s cancer and pairing it with the patient’s dendritic cells. Dendritic cells tell the immune system what to target.
All Arcelis needs is a small sample of the tumor. With that sample, Argos can make as much antigen as needed, Abbey said. Because the treatment is derived from the patient’s own cancer and dendritic cells, the personalized treatment gets the immune system to specifically target the cancer while also presenting no toxicity to the patient.
“We think we’ve really gone a step beyond most others in the field in realizing a cause and effect with our immunotherapy,” Abbey said.
Abbey expresses confidence about the treatment’s prospects for U.S. Food and Drug Administration approval. He said that with the approval last year of Dendreon‘s (NASDAQ:DNDN) personalized prostate cancer treatment Provenge, regulators are better informed of such immunotherapies. But Abbey also points to differences between Provenge and Arcelis. Notably, one production run of Arcelis can yield 24 doses for a patient. A single Provenge production run yields just one dose. That makes Provenge more expensive and personalized immunotherapy is not cheap. Dendreon prices Provenge at $93,000 a year. Abbey won’t discuss Arcelis pricing and says only that it will be comparable to other biologics.
Dr. Robert Figlin, chair of the department of hematology/oncology at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center in Los Angeles, said that he’s been following developments of kidney cancer treatments for more than 30 years. Arcelis, he said, has the capability of becoming a breakthrough medical technology. The existing therapies for kidney cancer don’t have the same ability to generate a patient-specific immune system response.
Figlin, who participated in the phase 2 trial of Arcelis, said the treatment would be paired with the Pfizer (NYSE:PFE) kidney cancer drug Sutent. He said that if Arcelis were available now, he would start all of his kidney cancer patients on the combination of Sutent and Arcelis therapy from the start.
Argos’s research into Arcelis as an HIV treatment is still in mid-stage clinical trials. Because the virus differs from patient to patient, Abbey said that the technology is well suited as an HIV treatment because it would offer patient treatment personal to their version of the virus. The company’s Arcelis HIV study has been funded by a $32 million contract with the National Institutes of Health.
Argos was founded in 1998 as Merix Bioscience, a company based on RNA technology licensed from Duke University. The company has raised more than $80 million from a syndicate of investors that includes The Aurora Funds, Forbion Capital Partners, Genechem, Intersouth Partners, Lumira Capital and TVM Capital. Abbey said that proceeding with late-stage clinical trials will require a new investor or a pharma partner.
Genetically engineered cancer therapies are attracting pharma interest. In January, Amgen committed up to $1 billion — $425 million up front and another $525 million for milestones — to buy biotech company BioVex, which is developing a genetically modified virus to target cancer cells. Abbey said that Arcelis could be applied to other cancers besides kidney cancer. Arcelis would also offer pharma technology with efficacy, no toxicity and resistance to generic competition.
“You can’t make a generic because it’s a completely personalized approach,” Abbey said.
Depending on clinical trials and regulatory approvals, Abbey estimates that Arcelis could be on the market by early 2015.