Our breakthrough DigiLum™ solution expands the use of PDT to more cancer sites and new surgical settings to enable this proven therapy to reach more patients. Its mechanism of action in applying oxidative stress involves no toxicities and can drive multiple clinical results including tumor ablation, immunogenic cell death, and local tumor control in patients undergoing surgical resection. PDT is tumor-agnostic with no acquired resistance, does not interfere with other therapies, and can be applied with minimum damage to healthy tissue for excellent cosmetic and organ function-sparing results. Lumeda is pursuing new indications for PDT as a more tolerable, effective, and toxicity-free alternative to chemotherapy and radiotherapy.
Local Treatment- Systemic Response
Our initial indication for DigiLum™, currently under clinical evaluation, is an adjuvant therapy to improve the response rate of immune checkpoint blockade in treating patients with lung cancer. Our therapy selectively destroys tumor cells locally, while potentiating the immune system to recognize and attack residual and distant disease cells. Other therapies that elicit immunogenic cell death, such as chemotherapy and radiotherapy, are unspecific and can be immunosuppressive in destroying immune components along with the cancer. In contrast, our therapy is more selective to maintain these critical immune components without toxicities or severe side effects. Our goal is to advance PDT as a more effective and tolerable therapy in combination with immunotherapy for patients with lung cancer and pleural disease.
Enhanced Visualization and Local Control
Our DigiLum™ solution presents an effective intraoperative adjunct therapy for treating positive surgical margins as an option to intraoperative radiotherapy and/or chemotherapy. We leverage the dual diagnostic/therapeutic capability of Gleolan™ to improve visualization of positive margins in-vivo in the surgical bed after tumor resection, to then apply therapeutic PDT to destroy residual disease. Positive surgical margins lead to a high rate of disease recurrence especially in advanced stage tumors that invade tissue near nerves and vascular structures where complete resection is difficult. With minimum off-target effects along with the high selectivity of Gleolan™, our DigiLum™ solution is ideal in this setting to treat compromised surgical margins. A Phase 1 clinical study is planned to open early 2024 that evaluates safety and initial efficacy of image guided surgery followed by intraoperative PDT for improving local tumor control in patients undergoing surgical resection of locally advanced or recurrent colorectal cancer.