Argos raises $25M for kidney cancer immunotherapy phase 3 study

Immunotherapy company Argos Therapeutics, which last month withdrew plans for a $65 million initial public […]

Immunotherapy company Argos Therapeutics, which last month withdrew plans for a $65 million initial public offering, has now secured a $25 million round of financing to start phase 3 clinical trials on its novel kidney cancer treatment.

Forbion Capital led the series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds. With the financing, Durham, North Carolina-based Argos expects to start clinical trials in the middle of this year.

Argos’ immunotherapy technology, called Arcelis, takes a personalized medicine approach in prompting the body’s immune system to fight disease. With Arcelis, the company developed lead therapeutic candidate AGS-003 to target renal cell carcinoma, the most common form of kidney cancer. AGS-003 uses a tumor sample from the patient’s own dendritic cells to create antigen to fight the cancer. Because the treatment is developed from a patients’ own cells, it is unique to that patient.

Full phase 2 results of AGS-003 were reported in February. Those results showed that when used with sunitinib, a cancer drug that is the standard of care for renal cell carcinoma, the combination prolonged survival and also showed that the treatment’s mechanism of action has a correlation with improved overall survival. CEO Jeff Abbey said no other cancer immunotherapy has been able to show these results. Investors apparently did not recognize that potential or were wary of taking the risk of investing in the experimental treatment. Abbey said Argos withdrew the IPO plans because investors were not willing to invest at a point that valued Argos as much as the company and its existing investors thought it was worth.

“Public investors have been burned by so many cancer immunotherapy companies that there’s still a lot of skepticism,” Abbey said. “Because our mechanism of action is so unique to us, I think it’s fair to say it wasn’t fully appreciated by investors.”

The phase 3 studies could remove some of that skepticism. The studies aim to confirm the phase 2 results. Abbey said that the company is proceeding with the phase 3 trial plans it outlined in its stock filing. The $65 million targeted in the stock offering was never intended to fully finance the late-stage trials. Those plans said that $30 million would be used to start the AGS-003 study. With $25 million Argos gets to mid-2013, when the company expects to be two-thirds enrolled in the AGS-003 clinical trial. What Argos will have by then is more data from the first 40 to 50 patients who were enrolled in the study. With that data, Argos will be able to make its case for financing from a pharmaceutical partner, venture capital investors or even the public markets. Abbey said he would consider another IPO filing.

The phase 3 trial of AGS-003 will move forward under a revised special protocol assessment agreement with the U.S. Food and Drug Administration. The FDA in February approved the plan under which the agency reviews the design of the clinical trial to determine whether it is enough to support a regulatory filing. These agreements are intended to streamline the drug’s regulatory path.

AGS-003 is also in the FDA’s fast- track program, a program that expedites review for new drugs that address serious or life-threatening diseases or unmet medical needs. Fast-track designation cuts the review from 12 months to six months.

In the upcoming phase 3 trial, Argos will study the addition of AGS-003 to sunitinib compared to sunitinib alone. While AGS-003 is being studied with sunitinib, Abbey said that the Argos treatment could be used independent of sunitinib after five doses. That’s important because it gets patients away from the toxic effects of sunitinib. The study is expected to enroll about 450 metastatic renal cell carcinoma patients at 100 sites in North America and Europe. The study’s primary endpoint is overall survival. Secondary endpoints are overall response, immune response, progression-free survival and safety.

 [Image from Wikipedia]

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