Several natural-occurring human proteins have been shown to generate an immune response against human tumors. Tumor-associated proteins ("TAPs") are found in many solid tumors and in hematologic (blood) cancers such as myeloma, leukemia and lymphoma. TAPs have small peptide fragments on the protein that have been shown to induce a cytotoxic T-lymphocytes ("CTLs") response of the immune system to attack and eliminate tumor cells containing the TAP. OFA/iLRP is a TAP pursued by Benovus Bio that is strongly expressed in all hematologic malignancies, but not in normal blood cells of healthy people.

It has been shown that OFA/iLRP-specific CTLs, generated from healthy people with a common tissue type referred to as "HLA-A2", were capable of killing OFA/iLRP-expressing hematologic cancers, including lymphoma and leukemia cell lines, as well as fresh leukemic tumor cells from patients with acute myeloid leukemia (AML) and multiple myeloma, indicating that OFA/iLRP-derived peptides are naturally processed and presented by hematologic tumors causing them to be killed by the CTLs.

Therefore, it appears that the OFA/iLRP TAP plays a significant role in regulating host-tumor resistance or response by stimulating anti-OFA/iLRP-specific CTLs that propagate from one cell to millions of cells, circulate, find tumor cells, and kill them immunologically.

Benovus Bio has identified and developed immunogenic peptides that bind to human HLA-A2 and induce "killer" CTLs to be used as an "off-the-shelf" immunotherapy that works by activating the body's own immune system to attack cancer cells.

Benovus Bio is pursuing a proprietary mixture of 3 patented peptide fragments from OFA/iLRP that have been chosen for immunotherapy based on high affinity binding to HLA-A2 and have been reported to be cytotoxic T cell epitopes on the TAP protein called "Oncofetal Antigen" (OFA/iLRP). The proprietary BenovusBio peptide pharmaceutical formulation has been manufactured under good manufacturing practices (GMPs) and the product and process has been inspected by the FDA. The Phase I human safety and immunology study of the Benovus Bio product, called "BB-MPI-03" was authorized by the FDA in Q4 2014, and is scheduled to begin in Q1 2015. The peptides are administered intradermally (under the skin) following a low dose of an immune adjuvant, recombinant human Granulocyte-Macrophage Colony-Stimulating Factor ("GM-CSF" a.k.a. the commercial product "Leukine", Sanofi-Oncology, Inc.). The therapeutic intent is to treat leukemia and myeloma cancer patients with minimal residual disease after achieving a remission or in elderly patients who refuse or do not qualify for bone marrow transplantation. A key objective is to generate an immune response to cancer cells containing OFA/iLRP and induce a clinical response, or to prevent or delay recurrence in patients at high risk for relapse. The study is recruiting patents at the University of Michigan, University of Chicago, and Virginia Cancer Specialists.

For more information on the FDA Authorized Phase 1 Clinical Trial for Acute Myeloid Leukemia (AML), Multiple Myeloma (MM) or Myelodysplastic Syndrome (MDS) patients, please click here.