Vical Incorporated (NASDAQ:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a qualified infectious disease product (QIDP) designation to Vical’s investigational antifungal product candidate, VL-2397. The QIDP designation is for the treatment of invasive aspergillosis.
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
“The high mortality rate and emerging drug resistance call for new therapeutic options for the treatment of invasive fungal infections. It is exciting to see an antifungal with a novel mechanism of action and with rapid fungicidal activity in preclinical models. There is an urgent need for new fungicidal drugs in the clinics,” said John R. Perfect, M.D., Chief of Division of Infectious Diseases at Duke University Medical Center.
VL-2397, also known as ASP2397, is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in the ICU. In preclinical studies to date, VL-2397 has demonstrated faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.
“We are pleased that the FDA has granted QIDP designation to VL-2397 for the treatment of invasive aspergillosis,” said Igor P. Bilinsky, Ph.D.,Vical’s Senior Vice President of Corporate Development. “We are excited by the potential of VL-2397 to save lives of patients with systemic fungal infections, and the QIDP designation may enable us to expedite development of this novel antifungal. We plan to file an investigational new drug application (IND) and initiate a Phase 1 clinical trial for VL-2397 in the first half of 2016.” (Original Source)
Shares of Vical closed yesterday at $0.63. VICL has a 1-year high of $1.55 and a 1-year low of $0.60. The stock’s 50-day moving average is $0.66 and its 200-day moving average is $0.91.
On the ratings front, Vical has been the subject of a number of recent research reports. In a report issued on June 23, Roth Capital analyst Debjit Chattopadhyay downgraded VICL to Hold, with a price target of $1.65, which implies an upside of 161.9% from current levels. Separately, on the same day, H.C. Wainwright’s Mark Breidenbach reiterated a Buy rating on the stock and has a price target of $2.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Debjit Chattopadhyay and Mark Breidenbach have a total average return of 26.6% and -26.4% respectively. Chattopadhyay has a success rate of 61.0% and is ranked #23 out of 3740 analysts, while Breidenbach has a success rate of 0.0% and is ranked #3530.
Vical Inc is engaged in researching and developing biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.