On February 5, 2016 Elios Therapeutics begins enrollment of phase I/IIa melanoma trial (NCT02678741) combining approved check point inhibitors with the Elios personalized cancer vaccine (Press release, Elios Therapeutics, FEB 5, 2016, View Source [SID:SID1234515509]).

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The trial attempts to address the unmet need of metastatic melanoma patients who fail to respond to checkpoint inhibitors(CPIs) alone
The trial will underscore the natural synergies between vaccines and CPIs
The trial will use Elios’ autologous tumor lysate (TL), particle loaded (PL), dendritic cell (DC) vaccine (TLPLDC) currently in a randomized phase IIb adjuvant trial

Elios Therapeutics, LLC, has received FDA approval to proceed with a 45-patient study that will combine the company’s novel autologous vaccine technology (TLPLDC) with standard-of-care "check point inhibitors" in metastatic melanoma patients with stable or slowly progressing disease. The study will be conducted at leading clinical research sites in the U.S. and be led by Steven O’Day, MD, Professor of Medical Oncology, Director of Immuno-Oncology, Director of Clinical Research, The John Wayne Cancer Institute, Providence Saint John’s Medical Center, Santa Monica, California.

Checkpoint inhibitors such as Yervoy, Keytruda, and Opdivo are approved for use in patients with metastatic melanoma. A small subset of patients treated with such ‘checkpoint inhibitors’ will achieve a clinical complete response; however, the majority of patients will not. "While some patients may experience partial responses or stable disease, most will see their disease progress," commented Tom Wagner, PhD, the TLPLDC vaccine inventor: "Checkpoint inhibitors work on a patient’s existing T Cell population. In order for checkpoint inhibitors to be effective, the patient must have corresponding T Cells that can recognize and attack their specific disease. It is likely that patients who do not respond or partially respond to this therapy do not have any or enough specifically-corresponding T Cells to overcome their disease. The way you create those T Cells is through autologous vaccination. Our vaccine creates a specific immune response without toxicity in a production environment that does not carry the financial burden of other therapies – possibly a perfect combination."

In early clinical studies, the TLPLDC vaccine has shown effectiveness in both the adjuvant and metastatic settings. Elios is also currently enrolling a phase II(b) 120-patient adjuvant trial in stage III and IV (resected) melanoma patients (NCT#02301611). "The unique way that the TLPLDC vaccine presents antigen to the immune system with or without other therapeutic agents and the logistical ease with which the vaccine is produced makes it easily deployed in clinical settings," said George Peoples, MD, FACS, Chief Medical Officer at Elios. "We are excited about our progress in the ongoing adjuvant trial and encouraged that adding the autologous TLPLDC vaccine to existing check point inhibitor therapy will significantly improve patient outcomes in the metastatic setting."

"Immune Checkpoint Inhibitors have revolutionized the treatment of melanoma and other cancers," said Steven O’Day, MD. "Despite durable responses and prolonged survival in many patients the majority of patients do not respond to single agent checkpoint blockade. Novel combinations of checkpoint inhibitors with other immune modulators will be critical as we build on our new found success. Novel Vaccines offer a potential additive or synergistic role in combination with PD1 inhibitors with a favorable toxicity profile."

Initial readouts for (i) the 45 patient phase I/II(a) trial of the TLPLDC vaccine in combination with checkpoint inhibitors in metastatic melanoma patients, and (ii) the 120 patient phase II(b) adjuvant trial in stage III and IV (resected) patients to prevent recurrence are both expected in December 2016.