Our goal is to advance Photodynamic Therapy (PDT) as a treatment for patients with non-small cell lung cancer (NSCLC) and other thoracic malignancies. With DigiLum™ controlled light dosimetry, thoracic surgeons can precisely and reliably activate a photosensitizer drug to administer PDT to reduce disease spread and enhance antitumor immunity.
Lumeda is pursuing two preliminary indications for the product- an adjuvant applied intraoperatively following NSCLC tumor resection and an immune-modulating treatment to elicit antitumor response. Clinical studies were started in 2021 to investigate safety and provide an initial assessment of PDT effectiveness of each indication.
COMBINATION PDT + IMMUNOTHERAPY
Many consider the paramount achievement in cancer treatment over the last decade the introduction of immune checkpoint inhibitor agents (ICPi). ICPis are antibody-based immunotherapy drugs that mobilize the immune T cell response. Despite the promise of this immunotherapy, only 15-20% of patients benefit from it because they have so-called “cold” tumors that have not provoked a strong immune response. T cells are unable to penetrate such tumors being excluded by components of the cell microenvironment that stifle a normal immune response. ICPis work best in so-called “hot” tumors that have been infiltrated by T cells, creating an inflamed tumor. With T cells present within the tumor, they are mobilized against the cancer when ICPis trigger their release.
There is significant interest in developing treatment strategies that involve converting cold tumors to hot tumors by combining therapies that enhance anti-tumor T cell activity with ICPis. PDT provokes a strong acute inflammatory reaction observed as localized edema at the targeted site- a result of PDT-induced oxidative stress which can activate an immune response against tumor cells. PDT-induced immunomodulation of the tumor microenvironment and its ability to reset checkpoint homeostasis has been validated in numerous pre-clinical studies on animal models. These studies show that cancer tumors treated with PDT can stimulate the host anti-tumor response and alter the immune contexture to overcome tumor immunosuppressive activity and potentially increase patient response to ICPis. Other studies show that PDT dosing can be modulated to promote these effects.
Lumeda’s DigiLum™ is an ideal platform to offer a level of control required to optimally stimulate these effects. Currently several ICPi agents targeting the PD-1/PD-L1 axis are indicated for use in treating NSCLC based on stage, disease progression, and genomic test screening. The Lumeda solution has the potential to be among the first used in clinical studies to evaluate safety and effectiveness of PDT in combination with immune checkpoint inhibitors as a synergistic anti-tumor therapy in treating NSCLC with pleural disease.
INTRAOPERATIVE ADJUVANT THERAPY
Of new lung cancer cases, 84% are non-small cell lung cancer (NSCLC). Of these cases, approximately 30% are surgical candidates in which tumor resection, which can be curative, is the primary standard of care treatment.
Tumor resection is often followed by adjuvant therapy in some stage IB to IIIA patients where there is a risk of local failure and disease recurrence. This can be the case with close margins in proximity to vascular structures, tumor invasion of the chest wall, or lymph node involvement tin which microscopic disease is difficult to completely remove. Current adjuvant therapies typically involve toxicity and other side effects, acquired resistance and limited tolerance in many patients.
Lumeda’s DigiLum™ presents a novel therapeutic paradigm in adjuvant therapy post-resection in applying a local therapy to the regional lymph node basin that is delivered immediately following resection of a primary tumor and its draining lymph nodes. Adjuvant PDT applied intraoperatively in this setting could dramatically reduce risk of disease recurrence and extend progression-free and long-term survival without the side effects of other adjuvant therapies.