NEWS AND DEVELOPMENT

  • Interim Phase IIb Data Show Promising Reduction In Risk of Recurrence and a Well-Tolerated Safety Profile in Patients with Resected, High-Risk Melanoma
    More
  • TLPLDC Demonstrates Encouraging Clinical Activity and Favorable Safety and Tolerability Profile in Combination with FDA-Approved Systemic Therapies
    More
  • Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence.
    More
  • Vaccine for Cancer Comes Closer to Fruition as Immunotherapy Pioneer Joins Orbis Health Solutions
    More
  • Buddy Long, president of Perseus PCI, the advanced cancer treatment center headquartered in the Cayman Islands, has announced the appointment of Dr. Sook Yin MD as treating physician and clinic director at the company’s Cayman Islands clinic.
    More

About Orbis

Realizing the Promise of Immunotherapy

Orbis’ lead product is the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, an autologous,
personalized, therapeutic cancer vaccine designed to stimulate the immune system to recognize tumor cells and fight a patient’s specific cancer. Just like every patient is unique, so is every tumor, so it is important to treat each patient’s tumor individually.

TLPLDC is an autologous, or personalized, 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 currently being investigated as an adjuvant melanoma therapy in patients with a high-risk of recurrence in the monotherapy setting (Phase IIb) and in combination with standard of care checkpoint inhibitor therapy (Phase 1a) at leading academic cancer centers in the United States. Additionally, we are evaluating a Tumor Lysate, Particle Only (TLPO) vaccine, a next generation formulation of TLPLDC, in a 60-patient bridging study aimed at demonstrating equivalency between both products. The TLPO formulation eliminates the need to draw blood and further reduces the time to develop the vaccine, resulting in a more streamlined manufacturing process.

The TLPLDC vaccine has been proven safe through use in more than 300 patients without any toxicity or serious adverse events. Combined with its ability to educate the immune system with a patient’s unique tumor-specific antigens, TLPLDC is able to eradicate tumors more effectively while preventing them from metastasizing and protecting patients from disease recurrence. As a result, we believe TLPLDC has the potential to become an important and foundational therapy for patients with solid tumor cancer.

Robust Intellectual Property

Orbis’ immunotherapy platform is a differentiated and compelling pathway for targeting cancer. Our patent estate includes a large number of issued patents and patent families covering methods and uses of our proprietary immune-mediated technologies, manufacturing processes, and their derivatives. We believe these patents provide substantial competitive advantages and puts Orbis in a strong position to grow the company over the long term, and to bring breakthrough, life-saving therapies to patients in need.

Strategic Alliances

Orbis has established important alliances with several strategic partners to support clinical development, manufacturing and commercial capabilities.

In an effort to rapidly translate our next-generation of immunotherapies for the treatment of cancer, we conducted extensive research to identify countries with strict regulatory structures that would enable us to treat patients faster while upholding the rigorous standards set forth by the FDA. As a result, Perseus PCI (Personalized Cancer Immunotherapeutics) was established in the
Cayman Islands as a whollyowned subsidiary of Perseus Holdings USA, LLC and as the treatment center for the Company, responsible for conducting the Phase I TLPLDC basket clinical trial in a variety of solid tumor types. Perseus PCI is the clinical potential of the TLPLDC therapeutic cancer vaccine in 15 different tumor types. In close collaboration with the FDA, the data collected will be used in current and future FDA IND applications. Perseus Holdings USA, LLC controls the master license for the TLPLDC/TLPO immunotherapy platform.

Elios Therapeutics, LLC is the U.S. Sponsor of the ongoing prospective, randomized, double-blind, placebocontrolled Phase IIb clinical trial of the TLPLDC vaccine, the Phase I/IIa checkpoint inhibitor + TLPLDC combination study in the metastatic melanoma setting, and the TLPLDC vs. TLPO bridging study.

We are steadfast in our pursuit of the development of next-generation immunotherapies that will make a meaningful difference in the lives of patients, caregivers and physicians. For more information about our people, science and pipeline, please visit orbishealthsolutions.com.

At-A-Glance

Headquarters:
111 Smith Hines Rd, Suites E & F,
Greenville, SC 29607
Founded: 2009
Founder & Chief Medical Officer: Thomas E. Wagner, Ph.D.
President: Riley Polk
Number of patents: More than 200 patents issued (53 foundational)
Facilities: 7,000 square feet