Elios Therapeutics, a biopharmaceutical company developing particle-delivered, dendritic cell vaccines in the oncology arena, today presented initial open-label results from the ongoing Phase 2b clinical trial of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with stage III and IV (resected) melanoma. Results were presented at the American Association for Cancer Research (AACR) 2018 Annual Meeting held April 14-18, 2018 in Chicago, Illinois.
In an ongoing prospective, randomized, double-blind, placebo-controlled Phase 2b trial, patients with resected Stage III and IV melanoma were randomized (2:1) to received either TLPLDC vaccine or placebo to prevent recurrence. All patients who recurred on the trial (met study endpoint) were then offered open-label TLPLDC along with standard of care therapy as determined by the patient's treatment team.
The initial open-label results presented were from 22 patients. Seven patients had their recurrences resected and were treated with the TLPLDC vaccine to prevent a second recurrence. At 12.5 months of median follow-up, only one patient has recurred.
The remaining 15 patients were on a variety of FDA-approved systemic therapies for their non-resectable recurrences. Of these patients, two patients withdrew from the study and one was not treated. In the remaining 12 patients treated with the TLPLDC vaccine in combination with their standard of care systemic therapy, two patients had a complete response (median follow-up 8.6 months), seven had stable disease and two had progressive disease. One patient progressed initially on TLPLDC vaccine alone but was converted to a complete response once checkpoint inhibitor therapy was initiated. Importantly, the addition of the TLPLDC vaccine did not increase the toxicity of checkpoint inhibitors, BRAF/MEK inhibitors, or TVEC in these patients.
TLPLDC vaccines are created via a process by which dendritic cells (DC) are exposed to a patient’s particular tumor antigens, creating a patient-specific DC vaccine. This results in the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine.
Little information about the company or product is available on Elios' website. Most of the site is incomplete with the majority of the pages simply stating “coming soon”.