TLPLDC is an autologous therapeutic cancer vaccine that is made from a patient’s own cells and is designed to stimulate the immune system to recognize tumor cells and fight the patient's specific (or unique) cancer.
TLPLDC is indicated to prevent reoccurrence of melanoma and achieve disease-free survival (DFS).
TLPLDC vaccine candidate is injected intradermally monthly x 3 followed by boosters at 6, 12, and 18 months.
July 17, 2019, Elios Therapeutics, announced positive top-line results from the Company’s prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating its' lead immuno-oncology candidate, the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, in patients with Stage III and IV resected melanoma. The study met its primary endpoint by demonstrating a statistically significant reduction in the risk of disease recurrence at 24-months (disease-free survival; DFS) in the per treatment (PT) population.
Clinical Trial NCT02301611: Phase IIB TL + YCWP + DC in Melanoma
- The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients.
- Our vaccine approach consists of harnessing the most potent antigen-presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer.
- We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine.
- The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC.
- These autologous tumor lysates, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.
Clinical Trial NCT02678741: Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.
- This Phase 1/2 trial is to assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.