Indications

Our goal is to advance Photodynamic Therapy (PDT) as a more tolerable treatment for patients with pleural malignancies. Our DigiLum™ platform enables thoracic surgeons to precisely and reliably administer PDT to enhance antitumor immunity. Lumeda is pursuing an initial indication for the product- an immune adjuvant applied intraoperatively during standard of care procedures to elicit anti-tumor response. Clinical studies were started in 2021 to investigate safety of DigiLum™ PDT applied intraoperatively in the pleura, and safety and an initial assessment of immunogenic PDT effectiveness of combination PDT + ICI immunotherapy with/without chemotherapy.

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COMBINATION PDT + IMMUNOTHERAPY

Lumeda’s initial therapeutic focus is on DigiLum™ PDT as combination therapy with immune checkpoint inhibitors (ICI) to improve response and treatment outcomes of patients with late-stage lung cancer. 

Many consider the paramount achievement in cancer treatment over the last decade the introduction of ICIs – monoclonal antibodies that mobilize the immune T cell response.  Recent studies report significant survival gains for patients with late-stage lung cancer receiving ICI over chemotherapy (KEYNOTE 010) with 5-year survival rate of 25% versus 8.2%, and over twice the median overall survival (16.9 months versus 8.2 months in expression positive patients with PD-L1 Tumor Proportion Score 50% or greater).

The efficacy of ICI is dependent on the presence of T cells in the tumor and the expression of immune checkpoint markers. Unfortunately, despite the promise of ICI, only a minority of patients (<20%) receive complete benefit from this immunotherapy because they have weak pre-existing anti-tumor immune response or “cold” tumors.  T cells are unable to penetrate such tumors being excluded by immune-suppressive components that stifle a normal immune response. Patients with pre-existing anti-tumor immunity or “hot” tumors respond better to ICIs, whose tumors are infiltrated by T cells that are mobilized against the cancer when ICIs trigger their release.

There is significant interest in developing treatment strategies to convert cold tumors to hot tumors by combining therapies that amplify the response to ICIs. One way to boost anti-tumor immunity to be more receptive to ICI is to include an immune adjuvant in the multimodality treatment of the disease. PDT is among the few technologies that can induce immunogenic cell death (ICD). ICD refers to a tumor cell death mechanism that produces an immune response through release of danger signals (damageā€associated molecular patterns -DAMPs) in the microenvironment surrounding the tumor which can stimulate a dysfunctional immune system. DAMPs can potentiate the adaptive immune system via uptake of tumor-specific antigens from dying cells for a systemic anti-tumor response. Unlike other ICD inducers such as some chemotherapeutics, radiotherapy, and oncolytic viruses, PDT has no toxic side effects and can be repeated with no loss of efficacy.  Furthermore, PDT has the potential to be an ideal immune adjuvant to ICI as PDT regimens can be designed to activate antitumor immunity, and the therapy has limited off-target effects due to its preferential activation in tumor cells within the tumor boundary.

Numerous preclinical studies have shown that PDT mediated ICD can enhance anti-tumor immunity by CD8+ T cell activation and tumor infiltration, and can significantly increases PD-L1 expression in the tumor stroma and reinvigorate exhausted T cells. These studies also demonstrate PDT working in synergy with ICI to improve the efficacy of ICI.  Lumeda’s DigiLum™ is an ideal platform to offer a level of control required to optimally induce ICD and deliver immunogenic PDT. The Lumeda solution is the first under clinical study evaluating safety and effectiveness of PDT in combination with immune checkpoint inhibitors as a synergistic anti-tumor therapy in treating NSCLC with pleural disease.