Periodic Reporting for period 1 - BGCI (Bacterial Ghost Cancer Immunotherapy - A new standard in tumour therapy based on the bacterialghost platform technology)
Reporting period: 2017-03-01 to 2017-07-31
Tumours represent complex heterogeneous system built up by cancer cells and distinct non-malignant cell populations including immune cells, cancer-associated fibroblasts, angiogenic vascular cells, and lymphatic endothelial cells actively participating on disease progression all together forming the so called tumour microenvironment (TME) . The stimulation of an anti-tumour immune response is primarily evoked by the immunogenic cancer cell death (ICCD) leading to enhanced release of endogenous tumour antigens, and the recognition and presentation of tumour-associated antigens (TAAs) by the stimulated antigen-presenting cells (APCs) – Dendritic Cells (DCs). Anti-cancer vaccination strategies involving DCs, the most professional APCs have underwent in past decades some of the most tremendous lengths of developments and improvements seen in the sphere for cancer therapy. Dendritic Cell-based autologous anti-tumour vaccine, otherwise known as cellular immune therapy of late stage cancer patients using a patients’ own dendritic cells (DCs), were found to be among the most professional and powerful antigen-presenting cells to be used, but needed to be activated ex vivo and loaded with cell lysates prepared from an autologous tumour (oncolysate) or a patient’s specific tumour-associated antigens.
The Feasibility Study showed that the BGCI with induction of HNSCC cancer cells, is viable technically and commercially, and the determination of the business plan shown that it is also a profitable investment. The clear market demand for cancer treatment, especially those of innovative technological backgrounds. Increased investments being made in this space by larger and more financially secure biopharmaceutical institutions. In the same vein, increased public resources and sentiments is being vested into these new avenues, of which qualifications in clinical scenarios become key to eventual commercialisation antics. The quantification of costs and the selection of collaborators, their distinct roles, with estimated budgetary concerns involved for core activities to reach first clinical revenues (through Phase I trials), as well as commercial partnership dynamics required for the first clinical output solution BGCI with induction of HNSCC cancer cell strain.
The solution provides for a natural, more targeted and personalised cancer treatment unseen with today’s technological options. The capacity of BGs to serve as a natural adjuvant is as effect of the intact morphological, structural and antigenic surface components of their living counterparts (bacteria) and can therefore provide general stimulatory signals to defence cells. As a result the patient immune system is strengthened and able to better respond to cancer treatments with a positive feedback mechanism that supports the primary targeted cytotoxic effect and further increase the therapeutic window. The added procedure of exposing patient cellular (ex-vivo) tumour biopsies to BGs induces the generation of the specific immune system in a fighting response to that specific tunmour type. These combined features as seen through BIRD-C’s pilot studies implications lead to better recovery outcomes including: A staggering >95% rate of non-relapse (ongoing) as immunological recognition supresses any form of resurgence within the body; as much as 20% faster recovery times; and negligible side effects felt (e.g. hair loss, nausea etc); all of these compared with existing gold-standard chemotherapy without use of BGCI.