Transgene Biotek Ltd Management Discussions.

CAUTION

 

Statements in the Management Discussion and Analysis describing the Companys and its subsidiaries objectives, projections, estimates and expectations may be ‘forward-looking statements within the meaning of applicable laws and regulations. Actual results could differ materially from those expressed or implied. Important factors that could make a difference to the Companys operations include among others, climatic conditions, economic conditions affecting demand-supply and price conditions in the domestic and overseas markets in which the Company operates, changes in the Government regulations, tax laws and other statutes and other incidental factors.

(a) Oral drug delivery technologies and opportunities

Pharmaceutical drug delivery technologies enhance drug absorption, efficacy, and patient experience. The main routes of drug delivery are oral, injection/infusion, and transdermal. When combined with appropriate targeting moieties, drug-coated nanoparticles, drug-encapsulating liposomes and nanotubes, and tree-like dendrimers enable organ and tissue targeting.

The use of nanotechnology in medicine and more specifically drug delivery is set to spread rapidly. Currently many substances are under investigation for drug delivery and more specifically for cancer therapy. A host of new delivery platforms is in development, some of which have recently reached the market. The primary goal of these developments is to create systems that optimize a drugs therapeutic value, but its also believed that finding better ways to get a drug into a patients system in a safer and more consistent way will lead to better compliance and outcome. Additionally, its estimated that up to 50 percent of new drugs cant be taken orally, so the impetus to create innovative delivery platforms is strong and growing.

TrabiORALTM

During the last two years TrabiORAL has emerged as one of the most exciting technology platforms on a global scale demonstrating its versatility in delivering different molecules of different sizes ranging from 4.8 kD 150 kD. It has demonstrated excellent bio-availability and efficacy in various pre-clinical studies. This successful demonstration of its efficacy and versatility has prompted Transgenes management to knock on the doors of various global pharma majors resulting in active dialogue for monetization of TrabiORAL covering different clinical areas.

(b) Emerging Gene therapy technologies and opportunities

One of the most revolutionary advances in this new era is cell and gene therapy. At its most basic definition, gene therapy (also called human gene transfer) is the therapeutic delivery of nucleic acid into a patients cells as a drug to treat disease. Gene therapy is the unique technique that uses gene to prevent or recover any diseases. The genuine, almost unprecedented potential for cell and gene therapy cannot be understated. For the first time, people are talking about curing these ruthless, relentless diseases. In a way never before possible, we are taking control of and harnessing the patients own immune system to fight these cancers.

The game changer here is that cell and gene therapy use the bodys own systems, either the cellular immune system or the ability to repair and replace defective or missing genes. CAR-T cell therapy is arguably among the most personalized medicines one can consider. The patients own T cells are extracted, modified, activated, expanded, purified and returned to the patient.

The promise of personalized medicine has been held out for a long time, and now were actually beginning to see real, tangible effects from decades of research into the genetics of the human genome and cancer, giving us an understanding of how the disease develops and how patients respond.

Several aspects of current research is focused on gene therapy, including: i) replacing a mutated gene that causes disease with a healthy gene; ii) ‘knocking out or inactivating, a mutated gene that is functioning improperly; and iii) introducing new genes into the cells to protect from any diseases.

The gene delivery systems consist of the three components such as a plasmid-based gene expression system that controls the function of a gene within the targeting cell, a gene that encodes a specific therapeutic protein, and a gene delivery system that controls the delivery of the gene expression plasmid to specific location within the body. The successful gene delivery system requires the foreign genetic molecule to remain stable within the host cells.

Viruses mediated gene delivery systems utilize the ability of virus to inject their DNA inside host cells. Viruses used for gene delivery systems include retrovirus, adenovirus, adeno-associated viruses, and herpes simplex viruses.

Viral vectors based on DNA for gene delivery are usually longer lasting and integrating into the genomes. DNA-based viral vectors are lentivirus, poxvirus, adenovirus, adeno-associated virus, retrovirus, human foamy virus (HFV) and herpes virus. DNA-based viral vectors for gene delivery systems utilize the viral vectors to deliver genetic materials to the host cells. The viral vectors are efficient for delivering the genetic materials to the host cells. The DNA-based viral vectors for the gene delivery systems include plasmids containing transgenes for gene therapy. Although the DNA-based viral vectors are in early stages of clinical trials, the class of materials has been emerged to yield extremely promising candidate of gene delivery systems for gene therapy in the wide range of diseases including cancer, AIDS, neurological disorders such as

Parkinsons and Alzheimers diseases, and cardiovascular disorders.

Gene Therapy - Perspectives and opportunities for Transgene

There has been a resurgence in gene therapy efforts that is partly fueled by the identification and understanding of new gene delivery vectors. Adeno-associated virus (AAV) is a non-enveloped virus that can be engineered to deliver DNA to target cells, and has attracted a significant amount of attention in the field, especially in clinical-stage experimental therapeutic strategies. The ability to generate recombinant AAV particles lacking any viral genes and containing DNA sequences of interest for various therapeutic applications has thus far proven to be one of the safest strategies for gene therapies.

Adeno-associated virus (AAV) is one of the most actively investigated gene therapy vehicles. It was initially discovered as a contaminant of adenovirus preparations, hence its name. Simply put, AAV is a protein shell surrounding and protecting a small, single-stranded DNA genome of approximately 4.8 kilobases (kb).

Transgenes recombinant AAV delivery vector has already been granted USA patent in 2015 for the treatment of Hepato-Cellular cancer. With extensive knowledge and experience on viral vectors, in particular AAV, Transgene is at poised to grab the emerging opportunities in gene therapies and gene editing technologies.

Internal Auditing and Controls

The internal control systems of the Company are adequate and commensurate with the size of operations. These controls ensure that transactions are authorized, recorded and reported on time. They ensure that assets are safe guarded and protected against loss or unauthorized disposal.

The Internal Audit department carried out audits in different areas of the Companys operations. Post-audit reviews were carried out to ensure that audit recommendations were implemented.

The Audit Committee of the Board of Directors reviewed the audit program and findings of the Internal Audit department.

Outlook

The outlook for Transgene is highly promising considering the emerging prospects for TrabiORAL in its wide and diverse application covering various clinical segments such as Diabetes, Cancer and Vaccine areas.

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