Avax Opens Custom Manufacturing Facility for Cancer Vaccines
Custom pharmaceutical manufacturing means different things to different people. Leading manufacturing contractors, for example, can supply small quantities of lead compound analogs or multi-kilogram batches for clinical trials on a few weeks' notice. More intriguing from the consumer's perspective, however, are drugs custom manufactured—tailored—to a specific patient's needs.
We've heard this was coming, but everyone expected custom-tailored drugs to arise from complex genomic analysis of a patient or his disease, and that such products were years away. Not so. With the opening of its autologous cell cancer vaccine manufacturing and distribution facility in Philadelphia, Avax Technologies Inc. (Kansas City, MO) has show that the future is not only here, but its implementation was a lot less daunting than anyone would have thought. Avax's patented AC vaccine works by stimulating a patient's immune system to recognize and attack the specific types of cancer cells causing this disease.
"Opening this facility is a significant milestone for cancer vaccines, making it possible for us to bring technology out of the research lab and deliver it, as a product, to patients who may benefit from it," said Jeffrey M. Jonas, president and CEO of Avax. "Today, we are demonstrating the practicality of centrally manufacturing and distributing custom-made vaccines on a large scale in a clinically sound manner that was once considered impossible. We believe this facility will help demonstrate that custom-made vaccines can be as practical as off-the-shelf products."
The facility incorporates a cGMP cleanroom capable of processing hundreds of vaccines for patients enrolled in Avax's clinical trials. These trials will evaluate the efficacy of the company's melanoma vaccine, M-Vax, and its ovarian cancer vaccine, O-Vax.
To date, over 350 patients have been treated with M-Vaxa on an outpatient basis. Phase 2 studies indicated that in post-surgical patients with stage III melanoma, treatment with M-Vax was associated with survival rates of 55%, compared with historical survival rates of 22%. Further, data from a recent Phase 1/2 immunological study among ovarian cancer patients indicated that when administered after chemotherapy, O-Vax was effective in stimulating a positive immune response to unhaptenized tumor cells in eight of the nine patients treated, as measured by a delayed type hypersensitivity (DTH) test. M-Vax is currently being evaluated in a multi-center, pivotal registration trial. O-Vax is currently being evaluated in Phase 2 trials, one of which is sponsored by the National Cancer Institute.
Autologous vaccines are prepared using a patient's own tumor cells. Avax makes the vaccine by modifying the tumor cells with a molecule called a "hapten." This process, known as "haptenization," alters the tumor cells and makes them seem foreign to the patient's immune system. When the hapten-modified cells are injected into the patient, they stimulate the patient's immune system to recognize the cancer cells and destroy them.
The vaccine manufacturing facility was designed by Charles Matsinger Associates & R.G. Vanderweil Engineers Inc., and built by Barclay White, a construction company headquartered in Berwyn, PA, with offices in New Castle, DE, and Harrisburg, PA. The company operates in nine states and in Puerto Rico, with clients in the healthcare, educational, institutional, and corporate sectors.
Avax Technologies specializes in the development and commercialization of novel biotechnologies, immunotherapies, and pharmaceuticals for cancer and other life-threatening diseases using three core technologies: the AC Vaccine technology, topoisomerase inhibitors, and anti-estrogens.
For more information: David L. Tousley, CFO, Avax Technologies Inc., 4520 Main St., Suite 930, Kansas City, MO 64111. Tel: 816-960-1333. Fax: 816-960-1334.
By Angelo DePalma