FDA Clearance to Initiate Phase 1 Trial of the X-PACT System in Solid Tumors

DURHAM, North Carolina, August 31, 2021 — Immunolight, LLC, a clinical stage biopharmaceutical firm leading the way in advancing technologies to transform cancer treatment, announced today it has received FDA clearance to enter phase 1 study in patients with breast, melanoma, sarcoma and head and neck cancers.

The heart of the X-PACT (X-ray Psoralen Activated Cancer Treatment) system is psoralen, a naturally occurring compound which has been successfully used for decades in the treatment of autoimmune disease, skin disorders and certain skin and blood cancers. It has not, however, been able to be used to treat solid tumors due to the fact that UV light, which is needed to activate psoralen, cannot penetrate through tissue to reach the solid tumors. Immunolight has now made that possible.

Immunolight innovated materials that convert tissue penetrating energies, such as low dose X-ray, into UV light inside a solid tumor in the body. The energy converting materials are injected along with psoralen inside the solid tumor, then low dose x-ray energy is applied at the site. The energy converting materials convert the x-ray into UV light which activates the psoralen inside the solid tumor to kill the cancer.

“Transitioning into a clinical stage company represents a significant milestone in the company’s history and the potential beginning of a new era in cancer treatment,” says Immunolight founder and CEO, Rick Bourke.

Currently in its 15th year of multidisciplinary research and development activities, Immunolight developed X-PACT in partnership with Duke University and Duke Medical Center with a team of over 30 scientists, physicians and engineers. “Our highest priority has been to translate this amazing science into a paradigm-changing cancer treatment in patients,” Immunolight President Harold Walder says. “We are so excited to get this treatment into the clinic and potentially change patient’s lives and transform their treatment outcomes.”