The Institute of Biophysics and Cell Engineering offers consumers the Technology of Genetic Modification of Dendritic Cells for use in cell therapy for malignant skin neoplasms based under a commercial agreement with technical assistance and/or a license agreement and is looking for partners to conclude technical cooperation agreement.

Genetic modification of dendritic cells (DCs) represents one of the most promising approaches for developing personalized anti-tumor vaccines to treat malignant skin neoplasms, including melanoma and squamous cell carcinoma.
The primary goal of this modification is to overcome the mechanisms by which tumors "hide" from the immune system and to enable dendritic cells to present tumor antigens to T-lymphocytes with maximum efficiency.

Genetic transformation of dendritic cells "ex vivo" (outside the patient's body) is achieved using viral vectors (such as lentiviruses or adenoviruses) or through electroporation (the introduction of mRNA/DNA). This modification focuses on three key areas:
1. Delivery of tumor antigens ("loading" the vaccines);
2. Enhancement of DC migration and survival;
3. Secretion of stimulatory cytokines.

Significance of the technology
1. Targeted therapy:
- Dendritic cells play a pivotal role in activating the immune system, including the T-cell response. Their genetic modification strengthens the immune response against tumor cells.
- The technology offers high specificity, targeting only malignant cells for destruction while minimizing damage to healthy tissue.

2. Personalized approach:
- Genetically modified dendritic cells can be tailored to the specific antigens present in a patient's tumor, ensuring a highly personalized treatment.

3. Alternative to conventional methods:
- Standard treatments—such as surgery, chemotherapy, and radiotherapy often carry significant side effects. Cell-based therapy offers a less invasive and safer alternative.

4. Reduction of recurrences:
- Genetically modified dendritic cells can provide a long-term immune response, preventing the recurrence of malignant neoplasms.

Relevance of the technology
1. Rising incidence of skin cancer:
- According to the WHO, the number of cases of malignant skin neoplasms, including melanoma, is increasing annually, making the development of new treatment methods highly urgent.

2. Limitations of current treatment methods:
- Existing treatment approaches, such as immunotherapy using checkpoint inhibitors, are not effective for all patients. Genetic modification of dendritic cells offers new possibilities for patients who are resistant to standard therapeutic approaches.

3. Advancements in genetic engineering technologies:
- Progress in CRISPR/Cas9 and other genome-editing technologies allows for more precise and safe cell modification, making this technology viable for clinical application.

4. Integration with other treatment modalities:
- Genetically modified dendritic cells can be used in combination with other therapies, such as PD-1/PD-L1 inhibitors, to enhance their overall efficacy.

An innovative approach to treating melanoma—a type of malignant skin neoplasm developed at the Institute of Biophysics and Cell Engineering, involves the use of genetically modified dendritic cells that persistently present tumor-associated and/or tumor-specific proteins. The melanoma-associated protein MLANA (MART1 a melanoma-associated antigen recognized by T-cells) is overexpressed in melanocytes following their malignant transformation. Genetic constructs (lentiviral expression vectors) have been developed for the first time, encoding two engineered variants of the MLANA protein, designated MLANA-FLAG® and MLANA-FLAG®-LAMP1. These constructs can be used for the genetic modification of dendritic cells and the development of novel cell-based therapies for melanoma.

This information is featured in the catalog "100 Best Developments of the National Academy of Sciences of Belarus for the National Economy (2022–2023)," 2024, pp. 212–213. (in Russian)

Advantages of the technology:
- High specificity and minimized side effects.
- Potential for treating patients with drug-resistant forms of cancer.
- A personalized approach based on the molecular characteristics of the tumor.

There are no domestic or international equivalents.

A laboratory protocol has been developed.

The Institute of Biophysics and Cell Engineering carried out research work entitled “To develop a technology for generating human monocyte‑derived dendritic cells expressing the tumor‑associated protein MART1/MLANA, based on the transduction method.” The results were used in the development of the methodology.

The Institute of Biophysics and Cell Engineering is a leading scientific institution in the Republic of Belarus, specializing in genetic engineering, immunology and allergology, nanotheranostics and personalized nanomedicine, as well as experimental and applied virology.

The Institute’s fundamental and applied research areas include:

In the field of medical biotechnologies:
- Genetic engineering: development of innovative biomedical cell products based on genetically modified cells.
- Immunology and allergology: development of new methods for the diagnosis and treatment of allergic diseases and immune dysfunctions.
- Innovative vaccines: development of prototypes for domestic DNA and RNA vaccines for the prevention of viral diseases.
- New diagnostic approaches: development of novel technologies for the early diagnosis of diseases and methods for personalized medicine aimed at improving human quality of life.
- Genome editing: editing of somatic and induced pluripotent stem cells, enabling the treatment of various diseases, including rare (orphan) and genetic disorders.
- Synthetic morphogenesis: including the engineering of tissues and organs.

In the field of bioinformatic technologies:
- Structure-based design of next-generation drugs, including the development of innovative targeted anti-tumor and antiviral agents using structural bioinformatics methods.
- Synthesis of targeted therapeutic agents and their *in vitro* testing.

In the field of nanotheranostics and personalized nanomedicine:
- Development of targeted delivery systems for next-generation therapeutic agents using nanomaterials.
- Development of biological biochips for disease diagnosis. - Research into a wide range of biocompatible nanomaterials for the development of biomedical cell products, artificial organs, and novel materials with antimicrobial, antiviral, and anti-inflammatory properties.

Activities of the Center for Experimental and Applied Virology:
- Cultivation of viruses and the development of new methods for culturing human viruses to create tools for the diagnosis, medical prevention, and treatment of viral diseases.
- Development of vaccine prototypes, including those for influenza (inactivated and recombinant), African swine fever (vector-based), and pulmonary tuberculosis (a therapeutic vaccine based on donor dendritic cells), as well as innovative anti-influenza agents.

In recent years, the Institute has carried out a number of international contracts and agreements within the framework of European Union programs, as well as in collaboration with leading scientific centers, foundations, and organizations.

Official website of the Institute of Biophysics and Cell Engineering.

Consumers interested in purchasing the Technology of Genetic Modification of Dendritic Cells for use in cell therapy for malignant skin neoplasms under a commercial agreement with technical assistance and/or a license agreement.

Partners interested in developing and implementing the Technology of Genetic Modification of Dendritic Cells for use in cell therapy for malignant skin neoplasms under a technical cooperation agreement.