Vical Incorporated has reported top-line results from a phase III trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma. The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival.
This trial data will be further analyzed and detailed results will be submitted for publication.
"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B Samant, president and chief executive officer of Vical. "Based on this outcome, we are terminating the Allovectin programme and focusing our resources on our infectious disease vaccine programmes." Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."
"In the coming weeks, we will make the necessary changes to focus resources on our infectious disease vaccine programs and reduce expenses to conserve cash," said Samant. The company reported cash and investments of $70 million at June 30, 2013, which it believes is adequate for its anticipated needs at least through the end of 2014. Vical has multiple independent and collaborative infectious disease vaccine programmes:
Astellas Pharma Inc. initiated a multinational 500-patient phase III trial of ASP0113, Vical's investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in transplant recipients, for hematopoietic cell transplant (HCT) recipients in June and expects to initiate a phase II trial of ASP0113 for solid organ transplant (SOT) recipients later this year.
The company is planning to initiate a phase I/II clinical trial of its Vaxfectin-formulated therapeutic vaccine against herpes simplex virus type 2 (HSV-2) before the end of 2013.
The company's Vaxfectin-formulated CyMVectin prophylactic vaccine, designed to prevent CMV infection before and during pregnancy, has completed preclinical development and has an allowed investigational new drug application (IND). Vical is seeking a partner for further development.
Vical has licensed its proprietary Vaxfectin adjuvant to Bristol-Myers Squibb Company for use in the production of antibodies, and to Cyvax, Inc., a privately held vaccine development company, for use in malaria vaccines. The company is pursuing additional licensing opportunities for Vaxfectin.
Two of the company's licensees have products approved for use in animal health applications:
In 2005, Vical's licensee Aqua Health, a subsidiary of Novartis Animal Health, received Canadian approval to market its proprietary product, Apex-IHN, a DNA vaccine to protect farm-raised salmon against infectious hematopoietic necrosis virus (IHNV).
In 2009, Vical's licensee Merial, now a subsidiary of Sanofi, received approval from the US Department of Agriculture to sell a therapeutic DNA vaccine, ONCEPT, designed to aid in extending the survival time of dogs with oral melanoma.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.