The discovery of dendritic cells in 1973, resulting in a 2011 Nobel Prize in Physiology or Medicine, bridged the two principal aspects of immunity (innate and adaptive) first defined by Nobel Prize recipients in Physiology or Medicine in 1908. It was subsequently proved that dendritic cells, part of the innate immune system, orchestrate the immune response to specific antigens by absorbing antigens and, when activated, present the specific antigens to B and T cells that result in antigen specific adaptive immunity.
The Rockefeller University patents licensed by NeoStem are titled: "Methods for use of Apoptotic Cells to Deliver Antigen to Dendritic Cells for Induction or Tolerization of T Cells," (inventors: Matthew Albert, Nina Bhardwaj, Ralph M. Steinman, Kayo Inaba and Robert Darnell). Studies showed that dendritic cells can be removed from the body in their inactive form, loaded with antigens and then re-infused and activated leading to an antigen specific immune response, including immune responses directed against cancer antigens.
"By licensing these patents that relate to NeoStem’s DC/TC (dendritic cell/tumor cell) technology, which technology was acquired by us through the California Stem Cell, Inc. acquisition in May 2014, NeoStem continues to look proactively for opportunities to expand and defend its technology platform as we simultaneously plan to initiate our Phase 3 Intus clinical study that will investigate our DC/TC technology in metastatic melanoma this year," commented Dr. Andrew L. Pecora, Chief Visionary Officer of NeoStem.
This additional intellectual property from The Rockefeller University expands the breadth of the Company’s already comprehensive Targeted Cancer Immunotherapy Program patent portfolio, which portfolio includes inventions relating to critical aspects of a dendritic cell-based therapy, such as novel antigen-presenting cancer vaccines, stem cell growth media, and methods to produce the high purity cancer initiating (stem) cells that provide the critical antigen array with which the vaccine’s dendritic cells are pulsed.
NeoStem expects to initiate a pivotal Phase 3 clinical trial for NBS20, an autologous melanoma initiating (stem) cell immune based therapy intended to eliminate the tumor cells capable of causing disease recurrence.
The goal of the therapy is to eliminate or neutralize the tumor cells that are responsible for recurrence after medically induced tumor regression after a patient has already undergone other treatments which may have reduced tumor size, but failed to entirely eliminate the cancer.
NBS20 has been the subject of compelling trial results for the treatment of metastatic melanoma. As a result, NBS20 has been approved to enter a Phase 3 clinical trial with Special Protocol Assessment (SPA) and received Fast Track designation for metastatic melanoma, as well as Orphan Drug designation.