ISF35 Technology
Memgen's first-in-class lead product, ISF35, is a re-engineered CD40 ligand immunotherapy that targets CD40-expressing tumors and is designed to work in combination with chemotherapies. Preclinical and clinical research shows that ISF35 induces cancer cell death (apoptosis) through upregulation of numerous pro-apoptotic factors, including upregulation of pro-apoptotic members of the Bcl-2 family, caspase activation, induction of cell death receptors such as Fas, and activation of cell cycle growth arrest and apoptosis kinases such as p21 and JNK.
Furthermore, ISF35 is a powerful immunostimulatory molecule capable of inducing immune responses to kill cancer cells throughout the body. This potent combination of induction of apoptosis and anti-tumor immunity, in combination with the cytotoxic activity of chemotherapies, provides a strong cancer treatment capable of working at local and distal sites of disease involvement and ISF35 delivery.
ISF35 is currently being delivered to target cells using a replication-incompetent adenovirus vector (Ad-ISF35). This delivery system has proven safe and effective in numerous clinical studies. Typical patient responses include transient (1-2 days) and mild flu-like symptoms. Moreover, the technology platform and intellectual property allows for alternative delivery systems for tailoring to a particular disease or indication.
Clinical Results
Targeted treatment with ISF35 used in combination with chemotherapy maximizes clinical activity without adding unwanted drug toxicity. ISF35 has demonstrated compelling activity against B cell leukemias and lymphomas in preclinical studies. In clinical trials, including an ongoing trial supported by the Leukemia and Lymphoma Society, ISF35 in combination with chemotherapy has exhibited remarkable overall and complete response rates (70% and 40%, respectively) in patients with high-risk, fludarabine-refractory and/or 17p-deleted chronic lymphocytic leukemia (CLL).
