Advanced Lung and Colorectal Cancer Are the Two Leading Causes of Cancer-Related Deaths Globally
Lumeda Is Introducing New Therapy to Address These Challenges
The company was formed to commercialize novel medical device technology that expands the use of photodynamic therapy (PDT) into new sites and indications. PDT is a proven therapy that is safe and free of systemic toxicities to offer an effective therapeutic option for an improved patient and provider experience. Our breakthrough therapy overcomes the barriers of legacy PDT to spur broader clinical adoption. Our initial indications address major treatment gaps in the standard of care for patients with advanced lung and colorectal cancer - the two leading causes of global cancer related deaths. In addition, our therapy offers the potential to reduce health disparities of underserved or underrepresented communities who are disproportionally diagnosed with lung and colorectal cancers at an advanced stage.
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New Breakthrough in Photodynamic Therapy
Our DigiLum™ technology presents a revolutionary new method of administering PDT to treat solid tumors with a dramatic reduction in treatment time and precise light dosing to render the therapeutic effect more repeatably and reliably over legacy methods. Coupling our light activation technology with use of Gleolan™ (aminolevulinic acid HCL), a prodrug that preferentially accumulates in malignant tissue, results in more targeted PDT for minimal damage to healthy tissue. Unlike other agents, Gleolan™ quickly clears for only a short 24-hour period of photosensitivity compared to several weeks with other agents.
This combination is the ideal platform to leverage the many advantages of PDT as a friendly treatment modality over chemoradiation that presents no systemic toxicities, does not interfere with other treatments, is tumor-agnostic with no acquired resistance, with excellent organ function-sparing properties. Our product roadmap includes new devices to apply this technology in emerging interventional oncology applications.
New Hope for Patients with Advanced Lung and Colorectal Cancer
Our mission is to advance PDT as an effective, toxicity-free alternative to chemotherapy and radiotherapy. Our revolutionary PDT platform promises to reinvigorate this proven therapy to extend its use into new indications. We leverage the precise light dosing capability of our DigiLum™ system to promote PDT immunogenic effects for an immune adjuvant to improve response to immune checkpoint blockade for patients with advanced lung cancer with pleural disease. We exploit the dual functionality of Gleolan™ for an innovative theranostic procedure that combines fluorescence-guided surgery followed by intraoperative PDT for improved local control in patients with advanced or recurrent colorectal cancer undergoing surgery. This procedure will augment laparoscopic tumor resection surgery to improve detection and treatment of residual disease for reduced risk of disease recurrence in these patients.
A Clinical Stage Company
Lumeda is partnered with Roswell Park Comprehensive Cancer Center, a recognized center of excellence in PDT and worldwide leader in its use for treating many types of cancer, in the clinical evaluation of our therapy. Three clinical studies are currently open for initial evaluation of our therapy in treating patients with advanced lung and colorectal cancer.
Phase I safety of our DigiLum™ system in administering PDT for treating patients with pleural disease, as well as in combination with standard of care αPD-1 immunotherapy has been established with initial efficacy assessment through changes in immune biomarkers. A Phase I/II clinical study was opened in 2024 to evaluate the accuracy of fluorescence guided surgery and determine safety of intraoperative PDT using our DigiLum™ system in patients with advanced or recurrent colorectal cancer undergoing surgery.
Impact
After breast cancer, lung and colorectal cancer are the most commonly diagnosed cancers worldwide, with the majority of new cases diagnosed at an advanced stage. Our therapy addresses unmet needs to improve outcomes in the standard of care of these patients, which could positively impact large first case populations of our indications estimated to exceed 150,000 patients each year (US, EU, and Japan):
1st Case Lung Cancer: Patients with NSCLC with pleural spread or any malignant pleural disease that have failed standard of care immunotherapy ± chemotherapy.
1st Case Colorectal Cancer: Patients with advanced colorectal cancer with recurrent or T4 tumors that are candidates for surgical resection.
Our therapy can reduce the use of chemotherapy and radiotherapy and their toxicities and severe side effects for enhanced patient quality of life and improved patient and provider experience. Our solution is compatible for use intraoperatively in minimally invasive and robotic-assisted surgical procedures in a range of clinical settings.