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 the reoccurrence of melanoma and achieve disease-free survival (DFS).
Skin cancer is the most common of all cancers. However, melanoma accounts for only about 1 percent of skin cancers, but causes a large majority of skin cancer deaths, says Cancer.org.
Melanoma is more likely to grow and spread than other types of skin cancer. When diagnosed and treated at an early stage, melanoma has a high cure rate, however, patients with later stages of the disease carry a high risk for melanoma recurrence because some melanoma cells can remain in the body, even after surgery.
TLPLDC vaccine candidate is injected intradermally monthly x 3 followed by boosters at 6, 12, and 18 months.
February 7, 2020, Multi-institutional, prospective, randomized, double-blind, placebo-controlled phase IIb trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine to prevent recurrence in high-risk melanoma patients: A subgroup analysis presentation.
November 22, 2019, Elios Therapeutics announced the initial assessment of 36-month follow-up data on all patients in this study indicated that the ‘TLPLDC vaccine benefit is not only durable but continues to increase beyond 24-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.