Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official.
The vaccine candidates were licensed by Gliknik, Inc., located at the University of Maryland BioPark. Orphan status for the vaccines means that the startup firm will receive tax credits and marketing incentives from the Food and Drug Administration (FDA), which may hasten its development of the treatments. The vaccines were eligible because they are personalized for a limited number of patients.
"Advanced head and neck cancer is a challenging disease with limited treatment options. Even with chemotherapy, radiation, and surgery, people with advanced head and neck cancer may have a limited life expectancy of six to eight months," says David Block, MD, MBA, co-founder, president, and CEO of Gliknik.
The vaccines were designed in a precise manner to boost the immune system. They were invented by Scott Strome, MD, a professor at the University of Maryland School of Medicine. "The survival of head and neck cancer patients has not really improved in 30 years," says Strome, who included in the two vaccines certain compounds that act as biological recognition points for specific substances associated with some head and neck cancerous tumors.
Head and neck cancer is different from brain cancers and may include cancers of the tongue, tonsils, nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx.
Any proposed treatment for the total number of all head and neck cancers would actually be targeting more than the maximum 200,000 patients needed to qualify for the FDA's orphan status.
However, the two vaccines owned by UMB and the Mayo Clinic - Strome's former employer - are at the vanguard of so-called personalized medicine that targets specific genetic traits of only certain patients. Gliknik's two vaccines are specific to molecular substances, or antigens, of tumors. That reduces the patient population well below 200,000. Also, the FDA's Office of Orphan Products Development determined that the vaccines demonstrated encouraging signs in a pilot study run in 2006 and 2007, says Block.
Strome has worked on such vaccines for seven years. He designed the vaccines while at the Mayo Clinic, filed an Investigational New Drug Application with the FDA, and had the products manufactured. After he arrived at the School of Medicine in 2005, he and Block co-founded the company. An unusual clinical "R01" grant from the National Institute of Dental and Craniofacial Research supports clinical trials of the vaccines.