Gradalis, a privately-held, fully-integrated biotech based in Dallas, Texas, has closed a $24 million Series B round of financing.
Gradalis will use the funding to advance its autologous vaccine platform, FANG, through late-stage clinical trials and expand manufacturing capabilities to accommodate commercial launch of FANG. In addition, the funding will be used to progress the clinical and preclinical development of the company's bifunctional shRNA platform.
"The boost that we're getting from this round of financing enables us to execute our strategy to finish clinical testing, scale up manufacturing and bring FANG to the market for patients with advanced stage cancer," said David Shanahan, president, CEO and co-founder of Gradalis. "The success that we've seen with the FANG platform moves us closer to our goal of providing patients with safe, effective and personalized cancer therapeutics. We are pleased that both our existing and new investors enthusiastically share our goal of bringing these therapies to market."
Gradalis' most advanced program testing the FANG platform is a randomized phase II study in patients with advanced ovarian cancer. FANG is also being evaluated in patients with advanced melanoma, colorectal cancer with liver metastases and Ewing's sarcoma among other indications. The company has received Orphan Drug designation from the FDA for the ovarian cancer and melanoma indications.
A non-randomized phase I study of the company's FANG technology revealed a statistically significant survival benefit in patients with advanced stage cancer compared to patients who received other forms of treatment. The benefit is likely attributed to the triad approach which is designed into the vaccine to maximize its effect. Not only is FANG manufactured using each individuals' tumor to assure exposure to the appropriate antigens, but it also activates immune cells and prevents production of proteins that tumors use to avoid detection by the immune system.