Background
In nature AFP is an immune regulatory protein involved in protecting the fetus from attack by the mother’s immune system and is a carrier protein known for diverting and transporting nutrients from the mother to the embryo via AFP receptors which are found on all fetal cells. AFP receptors are also found on most cancer cells and immune system suppressor cells but are absent on normal cells.
Tech Overview
The clinical stage biotechnology company’s drug products use patented recombinant human alpha fetoprotein (AFP) with Immuno-Oncology, Theranostics and Immunotherapy products under development.
Immunotherapy Platform – It is well-known that many autoimmune diseases in women go into remission during pregnancy and there is a strong correlation between the level of AFP in mother’s blood and the decrease in the symptoms of her disease.
Targeted Immuno-Oncology Platform – AFP receptors disappear following fetal stage but show up again on almost all solid and liquid cancer cells. The company uses its proprietary recombinant human AFP to deliver a chemotherapy payload to selectively kill cancer cells. Lower toxicity of this targeted approach offers the ability to treat the patient more frequently until the patient is cancer free.
Advantages
- Immunotherapy platform
- Novel anti-inflammatory immune modulating agent
- Protein fully characterized
- Mechanism of action involves downregulation of multiple immune-mediated inflammatory pathways
- Massive safety data in over 300 humans – non-immunogenic
- International patents in place to 2025+ and additional 7/12 years market and data exclusivity as a biologic
- Pivotal/Phase II Ready in two indications – expansion to 40+ more
- Clinical Advisory Boards set – Orphan Designation in place
- Confirmation of efficacy in animal models
- FDA approved manufacturing process in place
- Targeted immune-oncology platform
- Novel targeted chemotherapy delivery platform – AFP
- Targeting protein fully characterized
- Mechanism of action well understood
- Massive safety data in over 300 humans – non-immunogenic
- International patents in place to 2025 + and new filings in 2021 and additional 7/12 years market and data exclusivity as a biologic
- Receptors found on >80% of all cancers (solid and liquid)
- Receptors found on MDSC cells
- Evidence of efficacy even in drug resistant tumors
- Demonstrated superior activity at low chemotherapy dose
- FDA approved manufacturing process for targeting agent in place