A cancer vaccine currently in clinical trials is being administered via a novel drug-delivery system. Panacea Pharmaceuticals Inc. is using the 3M Hollow Microstructured Transdermal System (hMTS) to deliver its investigational vaccine directly to the patient’s dermis.
“We have been working together for the past several years to move Panacea’s Cancer Vaccine product from preclinical studies and into clinical trials using our hMTS to deliver the vaccine,” explains Dr. Lisa Dick, MTS New Technology and Product Development Manager for 3M Drug Delivery Systems. “3M has supported Panacea in the development of the data package and submission for this clinical trial.”
Above: Dr. Lisa Dick, MTS New Technology and Product Development Manager for 3M Drug Delivery Systems
Benefits have already been seen in the cancer vaccine’s preclinical trials. “There are three advantages to Panacea for using the 3M hMTS system,” says Steven A. Fuller, Ph.D., Chief Operating Officer, Panacea Pharmaceuticals Inc., in a statement provided by a 3M spokesperson. “First, Panacea has demonstrated in preclinical studies that intradermal delivery of the cancer vaccine using the hMTS gives rise to a stronger immune response, than does the traditional intramuscular route of injection. This intradermal delivery is critical for enhanced efficacy of the cancer vaccine. The second benefit is the ability of the device to deliver the vaccine to the dermis consistently. The third is the market benefit of a cancer vaccine product that is matched with a delivery device that ensures consistent, easy delivery of the full vaccine dose.”
Above: Steven A. Fuller, Ph.D., Chief Operating Officer, Panacea Pharmaceuticals Inc.
The hMTS employs microneedles made from a liquid crystal polymer micromolded into the microneedle array, rather than stainless-steel microneedles. “Even though the microneedles have a limited duration of contact with the human body, the polymer is a USP Class VI material, the same type used in implantable medical devices. Biocompatibility studies on the molded microneedles address the limited duration of contact in this study. Because the arrays are micromolded, the process is easily scalable,” Dr. Lisa Dick says.
“3M’s hMTS is simple and easy to use for delivery of high volumes, up to 2.0 milliliters, of biologics and vaccines to the skin. The benefits of our device for cancer vaccine delivery include reproducible delivery to the dermis of skin to generate an optimal immune response, potential to deliver high volumes of vaccine, and the flexibility to have the vaccine given by the health care provider or patient,” she continues.
“Engineers who have experience in injection molding are stunned by the high fidelity and resolution of the microneedle structures,” explains Mike Sivigny, MTS Manufacturing Manager. “Microreplication is a 3M core technology, and microneedles are an example of how microreplication can be applied to meet a need in the marketplace."
Above: Mike Sivigny, MTS Manufacturing Manager, for 3M Drug Delivery Systems
3M microneedles can also be customized for attachment to other delivery systems, such as pumps or syringes. “It is possible to retrofit 3M microneedle arrays for attachment to devices via luer lock or other mechanisms," Sivigny says. "If the prototypes yield promising results, the next step is to fabricate single-cavity mold tooling to provide ‘production quality’ microneedle components for experimentation and potential clinical trials.”
Future innovations are planned for the microneedles. “Because of our micromolding process, it is straightforward to modify the length of the needles, the number of needles/array, the spacing of the needles, and the geometry of the needles," Dr. Lisa Dick says. "Such modifications may be needed to deliver higher doses of a product or to deliver to different parts of the skin.”
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