Elios Therapeutics Presents Primary Analysis of Phase IIb Study Showing Personalized Cancer Vaccine Significantly Reduces Risk of Melanoma Recurrence in High-Risk Patients

~ Vaccine Against Patients' Own Tumors Triggers Anti-Tumor Response; Is Safe, with Minimal Toxicity

~~ Nearly 60% Reduction in Risk of Disease Recurrence Observed Among Patients with Stage III and IV Resected Melanoma Who Completed the Primary Vaccine Series

~~ Detailed Findings Were Presented During the 16th International Congress of the Society for Melanoma Research Congress ~

AUSTIN, TX, USA I November 21, 2019 I Elios Therapeutics, a biopharmaceutical company developing innovative personalized therapeutic cancer vaccines, today announced that the Company presented the primary analysis of the prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating its tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine, in patients with Stage III and IV resected melanoma.

"Therapeutic cancer vaccines are an attractive alternative immunotherapy because of their potential safety, specificity, and long-lasting response due to stimulation of immune memory," said Mark B. Faries, M.D., co-director of the Melanoma Program and head of Surgical Oncology at The Angeles Clinic and Research Institute, an affiliate of Cedars-Sinai. "These results, coupled with a well-tolerated safety profile, support the rationale to further investigate the TLPLDC vaccine in combination with other immunotherapies and standard of care treatments, which may dramatically help to increase patient responses and prevent disease recurrence."

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. The vaccines were initiated within three months of completion of standard of care therapy at 0, 1, 2, 6, 12, and 18 months.  The primary endpoint was 24-month disease-free survival (DFS). The pre-specified per treatment (PT) analysis included all patients who completed the primary TLPLDC or placebo vaccine series (PVS) at six months. In the PT analysis, 24-month DFS was significantly improved in the TLPLDC vaccine group compared to placebo [62.9% vs. 34.8%; (HR=0.52, 95% CI: 0.27-0.98, p<0.041), representing a nearly 60% reduction in the relative risk of disease recurrence. There was a non-significant improvement in 24-month DFS between the TLPLDC and placebo arms in the intent-to-treat (ITT) analysis [38.5% versus 27%, (p=0.974)], but a stronger trend in improved 24-month overall survival (OS) in this analysis [86.4% vs. 75.1% (p=0.15)].

Therapy was well-tolerated with 31.7% of placebo patients and 35.9% of TLPLDC patients experiencing a related adverse event, the majority of which were grade 1 or 2. Additionally, an initial assessment of 36-month follow-up data on all patients indicated that the TLPLDC vaccine benefit is not only durable, but continues to increase beyond 24-months. As a result, the study will continue as designed to the 36-month landmark secondary endpoints of DFS and OS, anticipated in June 2020.

The TLPLDC vaccine is a personalized treatment that is created using a patient's own blood and tumor cells. Samples are collected at resection, frozen, and sent to the lab where they are used to create autologous tumor lysate, which is loaded into yeast cell wall particles (YCWP). This combination is then introduced to the patient's dendritic cells, leading to the creation of the final TLPLDC vaccine. The time from resection to injection of the vaccine takes approximately three weeks.

"This is a very different and personalized approach that is able to deliver each patient's unique composite of tumor antigens to the immune system," said John R. Hyngstrom, M.D., surgical oncologist at the Huntsman Cancer Institute and associate professor of surgery at the University of Utah. "Administered in a six-month regimen, the vaccine ignites an innate and adaptive response that trains a patient's immune system to 'see' melanoma cells and any of the specific proteins from their tumor that may be circulating throughout the body and kill them. A vaccine that can provide a protective benefit against melanoma would represent an important new tool for patients and their physicians," he added.

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. In the U.S, the incidence of melanoma has increased over the past decades, with 91,270 estimated new cases and 9,320 related deaths in 2018.1  

"Melanoma is an aggressive type of cancer that can spread to other parts of the body, even after successful treatment, making adjuvant therapy an important part of the treatment plan," said Kyleigh LiPira, M.B.A, chief executive officer of the Melanoma Research Foundation (MRF). "These results represent an important step forward in reducing the risk of disease recurrence, bringing us closer to the goal of helping each person with melanoma to have better outcomes and potentially extend survival."

"We are very pleased with the results of this study," said Buddy Long, chief executive officer of Elios Therapeutics. "We met with the FDA this month regarding Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations and look forward to our scheduled End-of-Phase 2 meeting in January to seek their guidance on the registrational Phase III trial design and optimal regulatory pathway for the TLPLDC vaccine. Our number one priority is to bring this safe and effective treatment to patients with melanoma as soon as possible."

About the Phase IIb TLPLDC Study
This Phase IIb study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with resected Stage III and IV melanoma. The primary endpoint of the trial is two-year disease-free survival (DFS).

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. TLPLDC or placebo vaccines were initiated within three months of completion of standard of care (SoC) therapies and were given at 0, 1, 2, 6, 12, and 18 months. The protocol was amended to allow concurrent checkpoint inhibitor therapy once approved for the adjuvant setting. Study participants were followed for recurrence per SoC. The primary efficacy analysis was performed on the intent-to-treat (ITT) and the per treatment (PT) populations as co-primary analyses given the high early recurrence rate often seen in patients with advanced melanoma. Secondary endpoints include 36-month DFS and overall survival (OS) which will be compared between the vaccinated and control groups.

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is a unique type of immunotherapy, both in how it is made and how it is delivered. The vaccine is personalized, meaning it is made from a patient's tumor and blood. Every patient's tumor has a unique antigenic profile unlike any other, and dendritic cells found in the blood are the most potent antigen-presenting cells in the body. Once TLPLDC is administered, it delivers the patient's complete repertoire of tumor antigens to the immune system, creating a dual innate and adaptive immune response, activating fighter T cells, and triggering the immune system to recognize, and seek out and destroy any cells containing the antigens and specific mutations from their tumor. 

Historically, autologous cancer vaccines have been rather onerous to develop, sometimes taking months between the tumor biopsy and administration. Elios has simplified the process so the time from resection to injection is approximately two weeks. This makes the vaccine highly feasible and will ultimately be easy for community and academic oncologists to adopt into their practices.

The TLPLDC vaccine is currently being studied as a monotherapy and in combination with standard-of-care checkpoint inhibitor therapies in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

About Elios Therapeutics, LLC
Elios Therapeutics, LLC, is a biopharmaceutical company developing a portfolio of innovative personalized therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types. Elios' lead therapeutic candidate is the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, a personalized therapeutic cancer vaccine that uses a proprietary particle delivery system to stimulate the body's immune system to recognize cancer cells as foreign pathogens and fight a patient's specific cancer. For more information, please visit www.eliostherapeutics.com.

1 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin 2018; 68:7–30_Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/29313949

SOURCE: Elios Therapeutics

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