AdAlta’s “East to West” cellular immunotherapy strategy is seeing the Company integrate Asia’s innovation in T cell therapy development with the efficiency and quality of Australia’s clinical and manufacturing ecosystem to create a pathway connecting ‘Eastern’ innovation in cellular immunotherapies with ‘Western’ regulated markets and patients. The strategy taps into a rich Eastern hemisphere cellular immunotherapy pipeline not currently reaching Western markets.
AdAlta in-licenses clinic ready products, many with clinical data already in hand, establishes a manufacturing base acceptable to the US FDA and conducts the first human clinical trials under a US FDA Investigational New Drug (IND) approval. Once successfully completed, each product can be on-licensed to larger biopharma companies for larger, potentially registrational studies, or it can conduct these additional studies itself.
AdAlta meets the needs of three distinct stakeholder groups (and in doing so creates value for its shareholders and investors):
- For patients, it selects and accelerates development of best-in-class assets with the potential for step change in the standard of care for solid cancers
- For larger western biopharmaceutical companies, it derisks assets by securing INDs, expanding patient safety profile, establishing broader indication potential, establishing optimal dose and bringing intellectual property, knowhow and supply chain into a US FDA regulated environment
- For Asian partners, it provides the funding and operational expertise to meet these needs of Western biopharmaceutical companies at no capital cost to themselves, all while maintaining a share of the upside.
AdAlta’s strategy is unique because it combines:
- Networks: Integrating Asia’s rich innovation with the efficiency and quality of Australia’s clinical and manufacturing ecosystem, and AdAlta’s pre-IND to clinical translation skills
- Strategic sourcing: Disciplined asset selection – focus on highly differentiated assets with clinical data in solid cancers
- Unique partnering model: asset financing for partners makes AdAlta a force multiplier and enables more valuable exit
- Capital efficient: AdAlta manages and develops each asset, including sourcing external capital to finance development; each project requires modest investment focused on a single clinical trial for major inflection and short time to value realisation
- Scalable: replicable across multiple assets
AdAlta’s “East to West” growth strategy is, in many ways, a biotech company version of the growth strategies adopted by many small cap mining exploration companies. Small resource companies acquire mineral projects, and then explore them with the help of funding sourced from farm-in arrangements with investors, who are often larger mining groups. In a similar vein, AdAlta’s “East to West” strategy will see the company managing and operating assets, financed by third party investment that bankrolls the development of each asset secured.
What are T cell immunotherapies
T cells are a type of immune cell that play a crucial role in the body’s defence against infections and diseases. However, cancer cells can evade and suppress the immune response. T cell immunotherapies are a new class of medicine that involves collecting a patient’s own T cells, enhancing and expanding them in the laboratory, and then reinfusing the T cells back into the patient body to more effectively recognize and destroy cancer cells.
A specific example is Chimeric Antigen Receptor-T cell (CAR-T) cell therapy. In CAR-T cell therapy, a patient’s T cells are engineered to express specific molecules on their surface that enable them to target cancer. These are connected to machinery in the cell that activates the T cell’s killing mechanism once the surface molecule engages a cancerous cell. To overcome the additional defenses of solid cancers, CAR-T cells may also be engineered to secrete additional molecules that counteract the immune suppression properties of cancer or enhance the CAR-T cells’ ability to migrate to the cancer.
The addressable market for “East-to-West” cellular immunotherapy strategy
The global cellular immunotherapy market, which AdAlta is targeting via its “East to West” strategy, is projected to reach US$20.3B by 2028, on the back of strong compound annual growth rates over coming years.
Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies
Recent FDA approvals for solid tumour therapies have set the stage for growth
Solid tumours projected to contribute greater than 50% of revenues by 2030
Asia leads in clinical trials (61%), providing a unique innovation pool.