Financing will support manufacturing plans for future commercialization and progress other clinical programs
DALLAS, Jan. 3, 2013 -- /PRNewswire/ -- Gradalis, Inc. today announced that is 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 2 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 for the ovarian cancer and melanoma indications.
A non-randomized Phase 1 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. FANG is not only 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.
The FANG vaccine is manufactured from a cell suspension derived from a marble-sized portion of a patient's tumor removed during surgery. A plasmid expressing a well-established immune activator, granulocyte macrophage colony stimulating factor (GMCSF), and Gradalis' proprietary bifunctional short hairpin RNA construct against furin is introduced into the cells by electroporation. Cells are then incubated overnight, irradiated, frozen, QC-tested and released. Vaccine is shipped to the patient's clinic where doses are thawed and administered monthly by intradermal injection. FANG manufacturing is a straightforward two-day cGMP process that is applicable to nearly all tumor types with no modification, and it does not require patients to undergo apheresis or other taxing treatment protocols beyond medically-indicated surgical tumor removal.
About Gradalis, Inc.
Gradalis, Inc. is a privately-held, fully-integrated biotechnology company based in Dallas, Texas that is focused on developing, manufacturing and commercializing drugs, vaccines, tools and diagnostics primarily in the area of cancer. The company has two primary platforms: one focused on personalized autologous vaccines and the other focused on bifunctional short hairpin RNA delivered via a proprietary lipoplex. Gradalis has its own state of the art GMP manufacturing facility along with high-skilled technical leadership and staff. More information on the Company and its programs can be found at www.gradalisinc.com.
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