FDA Phase 1 Clinical Trials

Immunolight has addressed all FDA requirements and has filed the Investigational New Drug application (IND). Clinical trials began in early 2022 at Duke University. The Phase 1 trial includes patients with breast, melanoma, sarcoma and head and neck cancers. Key milestones will be completion of the primary study and initiation of an expansion study in 2023.

In addition, the FDA has approved Immunolight’s treatment in compassionate use cases for patients who have failed multiple regimens of conventional therapy. The complete disappearance of multiple metastatic tumors was recently seen in a late stage IV triple negative breast cancer patient who became refractory to all available therapies. The patient had a single tumor treated yet demonstrated clearance of tumors in both sides of her neck, her chest and her abdomen. She remained disease free for three years after Immunolight’s treatment.

X-PACT Treatment Overview

Immunolight represents a paradigm shift in the treatment of cancer through the repurposing of an old drug into the front-line treatment of all types of solid tumors. Although very little data is available, thus far the safety profile has shown limited side effects with the most common adverse event being pain at the injection site both during and after injection.

Psoralen

At the heart of this paradigm shift lies the activation of a naturally occurring botanical drug, psoralen. While psoralen’s history dates to the ancient Egyptians, it’s immune modifying effects in the treatment of refractory psoriasis since the 1960s is well documented. Psoralen’s immune modulating characteristics were enhanced in the 1980s with the development of a novel cancer treatment, extracorporeal photopheresis (ECP). The ECP technology was developed by Rick Bourke, Immunolight’s founder, and ultimately licensed to Johnson and Johnson for worldwide development and distribution. In that system, white cells were treated outside the body with psoralen and reinfused back to the patient to engender a profound immune response against cutaneous T-cell lymphoma (CTCL), a malignancy of the blood. As a result, the U.S. Food and Drug Administration (FDA) fully approved the ECP treatment based on a single clinical trial of only 37 patients. The treatment remains the standard of care in that population of cancer patients.

Psoralen’s use has been extensively studied in other disease states. It has become a front-line treatment for Graft vs. Host disease, a potentially fatal side effect of bone marrow transplants. Its use has also been successfully demonstrated in rheumatoid arthritis, Crohn’s disease, scleroderma, and heart or lung transplant rejection. Thousands of peer reviewed articles describe the safety and efficacy of the drug.

Psoralen is a naturally occurring compound found in foods such as broccoli, figs and celery. It is inert and completely safe until activated with ultra-violet (UV) light. Upon exposure to UV light, psoralen photo-activates and modifies the intracellular DNA as well as other known cell signaling receptors. This causes cell death via a modality that engenders a profound antigen specific systemic immune response.

Until now, expanded use of psoralen has been limited, specifically in treating solid tumors, due to the inability of UV light to penetrate the skin and reach the tumor site.

Immunolight’s Breakthrough Technology

Activating psoralen inside a deeply embedded tumor required multiple breakthroughs in chemistry and physics. Immunolight developed multiple energy converting materials which efficiently absorb x-ray energy and convert it to UV light inside the tumor. The treatment is delivered by directly injecting psoralen and the energy converters into the tumor and following the injection with low dose x-ray energy from a standard radiation therapy system.

Immunolight’s technology is not restricted to a specific tumor type. Rather, it is directed at a characteristic common to all cancers, namely uncontrolled cell proliferation. Immunolight’s technology is expected to have broad clinical impact – offering dramatic anti-tumor effects. Thus far, in both the dog models and several compassionate use patients, substantial side effects have not been observed.

In vitro, the Immunolight technology has been shown to induce significant cell death in a variety of human and murine cell lines, including melanoma, brain, sarcoma, prostate and multiple variants of breast cancer.

Importantly, while cell death has been demonstrated in cell lines from numerous cancer types, non-malignant cells are not affected. In vivo, this is expected to translate to bypassing the devastating side effects of conventional chemotherapy and the harmful collateral damage of radiation. Indeed, the 60-plus year history of using psoralen has been remarkably side effect free.

Extraordinary results were also seen in a pilot canine study in companion canine animals with spontaneous tumors (see figure 1). Of note, unlike research based rodent models, the effects of treating spontaneous tumors in the dog is highly translatable to predictable responses in human cancers.

Become a Study Site

Immunolight is always looking for qualified Investigators to participate in our clinical trials.  At this time we are specifically seeking Oncologists, Surgical Oncologists or Radiation Oncologists.  Other requirements include experience as being an Investigator or Sub-Investigator in sponsored research and a thorough knowledge of regulations set forth by the Food & Drug Administration as well as knowledge of Good Clinical Practice.

Your site must also have the necessary infrastructure and personnel to support clinical trials.  Some of the requirements include: having a clinical research coordinator to collect/enter date, process/send laboratory specimens and maintain patient and regulatory files.  It is also necessary to have a dedicated locked temperature monitored storage space for investigational product and a storage/ work area for clinical research records and storing study supplies.

Our clinical trials also require a collaborative effort between the Investigator and Radiation Oncology. If you are interested in being an Investigator in one of our clinical trials, please complete the Practitioner Form.