Cascia
Cascia is a technology-enabled healthcare services and pharmaceutical
development company headquartered in Louisville, Kentucky. We conduct
research on the use of mesenchymal stem cell therapeutics for regenerative
medicine applications, and have a pipeline of drug candidates focused on the
treatment of fibrotic diseases.
Cascia's cellular therapies are based on autologous stem cells, which are cells obtained from the patient that is undergoing treatment. We do not use embryonic, fetal, or animal material in any of our therapies.
We establish cell processing laboratories at the hospitals where the patients are to be treated, and we prepare our therapeutics for immediate transplant back into the patient. Each dose of cells is prepared to prescription based on the individual patient's health status including their electrolyte values, hematological parameters, coagulation proteins, disease state, and other relevant factors. All preparation takes place according to strict protocols by technicians that have received special training, and preparation and quality release of each batch is extensively documented.
Unique among the cellular processing world, Cascia assigns a highly-trained medical scientist to each procedure. Our medical scientists have a PhD in a life science field, such as biochemistry, and have undergone additional company-sponsored training in therapeutic use of stem cells. The scientists provide an expert level of knowledge on cell therapies to ensure that the treating physician or surgeon obtains the best possible result for their patient, and to execute certain preparatory steps during the procedure.
We conduct research through company-owned facilities where we focus on several activities.
Our hospital-based processing laboratories are central to production of our cellular therapeutics. Controlling the preparation, processing, and quality controls related to our cellular therapeutics is a complex task that integratea the operation of numerous biomedical analyzers and our production equipment. We maintain an experimental laboratory that is substantially identical to our hospital-based processing centers for the purpose of training new technicians, evaluating different materials and instruments, and experimenting with process improvements. As process improvements are validated and documented at the pilot facility, they can be rolled out to the hospital laboratories after transition training is completed.
Information processing is as important to our business as our scientific experiments. While it is relatively simple to acquire and operate much of our scientific instrumentation, it is another level of effort to integrate all the devices to operate as a unified system, both for preparing cellular therapeutics and for conducting research. A key part of our strategy is to maximize use of IoT Technology (Internet of Things) which allows IoT enabled devices to communicate across the Internet for the purposes of scheduling necessary maintenance, monitoring performance, tracking calibration of instrumentation to standards, monitoring temperature excursion of refrigerators and freezer storing critical material, and to conduct remote supervision of quality control.
Most of our drug candidates were abandoned by major pharmaceutical companies for reasons unrelated to the efficacy of the drugs, generally due to shifting business strategy at the original developer. While each of these drugs has undergone an extensive preclinical development process by the original company, we generally do not have access to the original data and must repeat the testing prior to moving into clinical trials. This greatly reduces the drug development effort, both in terms of cost and time, and lets us move swiftly into human clinical trials. In other cases, the original developer had narrowed down the list of desirable candidates from tens of thousands of substances to just a few, but the final candidate to take to human trials has yet to be selected.
We plan to outsource portions of our development work to third-parties. These efforts will generally fall into two areas:
Contract Manufacturing: While we will have the capability to produce limited quantities of test substances in our own laboratories, we do not plan to create the capability to scale up to production-level quantities. There are numerous companies in the industry that specialize in contracted production of both small molecule and protein drugs to FDA standards, and we believe that using such companies is faster and less expensive that creating our own infrastructure.
Animal Testing: When any new drug is proposed for human testing, it must undergo toxicology testing in animal models, often multiple species. Ethical testing requires special facilities to house and feed the animals, experiments must be designed to gain the maximum amount of information with the fewest tests, and the animals must have access to proper veterinary care. All of that requires a substantial investment in facilities and specially trained personnel, and given our limited need for animal testing we believe that it is better to use third-part resources.