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The therapeutic potential is based on engaging the immune response to target specific tumor cells by forming a link between a patient’s T-cells (immune cells that protect from pathogens and infected cells) and tumor cells that trigger tumor cell apoptosis – programmed cell death.
From the research-based pharmaceutical industry in Europe.

Multiple myeloma is a rare type of bone marrow cancer -

the spongy tissue at the center of some bones that produces blood cells. The disease affects several areas of the body, such as the spine, skull, pelvis, and ribs. Multiple myeloma is characterized by the malignant transformation and proliferation (production of cells) of plasma cells, which are a significant part of the immune system. The changed cells accumulate in the bone marrow, leading to bone lysis and a higher risk of fractures. Tumor cells produce M protein instead of antibodies. The accumulation of this protein can make the blood more viscous and can be deposited in several organs.

The staging of multiple myeloma is realized by multiple criteria. Smo-ldering myeloma is the early stage characterized by increased plasma cells in the bone marrow, presence, or M protein without symptoms. The treatment is a “watch and wait approach”. In the first stage, the average survival is 62 months, and there is a relatively small number of myeloma cells with slightly elevated beta-2-macroglobulin levels, which indicates the disorders of renal filtration. Moreover, the levels of albumin may be decreased, which indicates liver damage or inflammatory disease. The second stage has an average survival of 44 months, it’s an intermediate stage if levels fall between Stage 1 and 2. The third stage has an average survival of 29 months and is characterized by high levels of myeloma cells and beta-2 macroglobulin, and low albumin. 30% of patients are diagnosed accidentally while being evaluated for unrelated problems, having clonal bone marrow plasma cells higher than 10%, and signs of end-organ damage.

Current therapy requires continuous administration of maintenance medication, which involves long-term side effects and high toxicity. This treatment greatly burdens the emotional and physical well-being of patients and their relatives. Treatment consists of hospitalization, consultations, and stem cell transplantation and requires a high expenditure on public resources. The financial aspect of multiple myeloma therapy is a leading financial challenge for the healthcare system.

Bi-specific T-cell engagers – BITEs are bispecific monoclonal antibodies representing innovative cancer immunotherapy that stimulates the patient’s immune system. In this manner, tumor cells can be eliminated by apoptosis – programmed cell death. The therapeutic potential is based on engaging the immune response to target specific tumor cells by forming a link between a patient’s T-cells (immune cells that protect from pathogens and infected cells) and tumor cells that trigger tumor cell apoptosis – programmed cell death.

BITEs link tumor cells and T-cells by leveraging two variable domains – one targeting tumor-specific antigens and the other on the surface of T-cells. By leveraging these domains, BITEs are designed to find specific antigens on the surface of cancer cells. In this manner, the need for antigen presentation and recognition is eliminated. Subsequent T-cell activation results in cytotoxic activity on tumor cells by releasing proteins entering the tumor cells and initiating the cell’s apoptosis. This therapeutic approach doesn’t require ex-vivo (outside the human organism) specific engineering of a patient’s T-cells. As a result, the deployment and administration of this treatment will be facilitated.

The expenditure on manufacturing and deployment of this therapy is lower, which will reduce the burden on the healthcare system and improve the allocation of resources. There are currently more than 258 trials studying the therapeutic potential of BITEs. The majority of the clinical trials are evenly split between Phase 1 and Phase 2. Cancer dominates the BITEs clinical trial pipeline – accounting for approximately 97% of all trials.

Multiple myeloma: What potential breakthrough are we awaiting?

BITEs-based therapy will prolong patients’ survival and alleviate the emotional burden. This novel approach will improve the quality of life and reduce the dependence on healthcare. In this manner, this therapy will offer possibilities for enhanced professional engagement and financial independence of patients. Prevention of the side effects of current therapy will provide significant socio-economic benefits. This approach will ensure an accessible treatment following a facilitated administration.

How will this approach help the patients?

The therapeutic potential of BITEs will improve patients’ survival which will provide possibilities to reach financial independence, enhanced productivity, and economic contribution to society. Current therapy requires continuous administration, which leads to several long-term side effects, both physical and emotional. This novel approach will provide effective treatment following a facilitated administration. This therapy will reduce the dependence on healthcare and the burden on the healthcare system resulting from long-term treatment. In this manner, the quality of life and social interactions of patients and their relatives will be improved.

How many patients will be concerned?

The number of patients with multiple myeloma in Europe is 125 thousand. This represents 1% of all cancer cases and 15% of the blood cancer cases. Multiple myeloma affects adults of any age but is much more common in people aged over 65 years and in men rather than women. Current therapy leads to long-term side effects and high toxicity. This novel approach will alleviate the emotional distress of patients and their relatives resulting from the current treatment. Improved economic productivity will contribute to financial independence.

What will be the potential impact on healthcare systems in Europe?

BITEs-based therapy for multiple myeloma will lead to a decline in hospitalizations because of prolonged survival and prevention of long-term side effects. This approach will reduce the expenditure on public resources and contribute to an improved allocation of healthcare resources. In this manner, the burden on the healthcare system will be alleviated, contributing to better access to healthcare. BITEs-based therapy will provide an accessible therapeutic approach and reduced expenditure on healthcare and public resources.


The therapies described above are currently under development and are not available to patients neither in Europe, nor in Bulgaria.

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