Pre-clinical Development of Human Galectin Proteins for Therapy and Diagnosis
of Cancer and Autoimmune Inflammatory Diseases
The Problem. Cancer and autoimmune inflammatory diseases such as juvenile diabetes, multiple sclerosis, Crohn’s disease and ulcerative colitis are incurable malignant disorders, involving pathological activities of cancer cells or cells causing inflammatory tissue destruction. Cancer remains the second main cause of death in the USA and costs $210 billion per year. Hundreds of billions of dollars are spent on the treatment and management of various autoimmune inflammatory diseases. Currently, there are no disease-specific drugs that destroy cancer or inflammatory cells involved in pathological activities that leave normal cells intact and functioning.
The Solution. Human galectin molecules represent a new opportunity and method to develop novel therapies for cancer and autoimmune inflammatory diseases. The galectin proteins target and bind to cells causing inflammation and cancer, causing them to die.
Our technology, involved in development of galectin molecules in these pre-clinical studies, has major advantages:
1. Therapy will be with human galectin proteins which do not need the lengthy development and very expensive process of humanization required by antibodies, for example.
2. Use of human proteins shortens the regulatory processes for clinical trials by appropriate authorities such as FDA and EMA.
3. The novel sequences of galectins are patentable and will not brake any exist IP rights of other organizations.
4. Using galectin proteins as a therapeutic approach for cancer and inflammatory diseases will reduce significantly the side effects of the treatment compared to chemothrapy and other treatments.
5. The manufacturing process of production and purification of galectins in bacterial systems will be very fast and cheap compared to production of other biological response modifiers such as antibodies. The newly developed drugs will be significantly cheaper for customers.
6. Time has a very important role in conferring high commercial value. Short development periods provide increased time for patent validation, increasing incomes and commercial benefits potentially by 2 – 3 years.
Statement of Commercialisation. Our products will be licensed to pharmaceutical companies with the resources to take them through clinical trials for co-development and marketing. Given that cancer and autoimmune inflammatory diseases are major therapeutic areas of all large pharmaceutical and biotech companies as well as many smaller biotech and especially pharmaceutical companies, we expect to form a range of similar strategic relationships for each of the products in our pipeline. We will carry out the following activities to effectively commercialize and out-license its product candidates:
Early prospecting — We have a thorough knowledge of the pharmaceutical and drug development sectors, an established industry network for collaboration and strategic alliances, and direct experience of in licensing and business development with leading global companies. We are familiar with the therapeutic focus and the product pipelines of many leading companies. In some cases, we know these leaders’ licensing priorities and criteria for various therapeutic areas. We have already initiated discussions with many potential licensees and will pursue ongoing relationships with a few of the most likely licensees who have demonstrated a strong interest.
Early negotiating — We. will start providing data and information sheets to likely licensees and begin general discussions of terms, deal structures, key issues, and item preferences to gauge true interest and capacity. We will seek to close term sheets with 2 or 3 of the most appropriate potential licensees.
Early closing — As soon as appropriate data is generated and verified, we will share this with key licensing candidates. The Company plans to complete the licensing package with pre-negotiated terms.
We expect initial income within six months of successful completion of tissue screening studies and the beginning of pre-clinical studies, after licensing the Company’s newly discovered galectin variants to a development and marketing partner - most likely a large pharmaceutical company. We will actively contact appropriate large pharmaceutical companies with the aim of establishing this type of deal. In the business’s projections, there are therefore no manufacturing costs, operating expenses, or capital equipment purchases assumed.
Based on its understanding and experience of similar licensing agreements, the business anticipates up-front payment upon licensing the product and subsequent clinical milestone payments and future product royalties.
College of Medicine
Swansea SA2 8PP