AGENT-797

Allogeneic iNKT cell therapy

At AgenTus, Agenus’s cell therapy subsidiary, we are advancing a pipeline of unique allogeneic cell therapies not only designed to address the limitations of autologous cell therapies but also many of the potential challenges of allogeneic cell therapy approaches currently being pursued.

Invariant natural killer T cells (iNKT cells) are a unique cell type that combines features of two critical arms of the immune system, T cells (adaptive immunity) and NK cells (innate immunity), making them invaluable in combating diseases like COVID-19 and cancer. Data from preclinical models that bear similarities to SARS-COV-2 suggest that iNKT cell therapy has the potential to eliminate the COVID-19 virus, dampen harmful inflammation, and promote protection from reinfection.

As for cancer, data from preclinical models show that AgenTus iNKTs can penetrate tissues, giving them a critical advantage in targeting solid tumors not currently served by approved cell therapies. These data also showed that the combination of checkpoint antibodies and iNKT cell triggering therapy shows curative potential in cancer models that are refractory to available therapies.

Our allogeneic iNKTs do not require any genetic manipulation and have been manufactured under GMP conditions and in significantly expanded quantities. Further, if approved they can be offered at a fraction of the cost of existing cell therapies.

The FDA has cleared the IND for AGENT-797 for use in patients with COVID-19 and cancer. AgenTus is advancing iNKT cell therapy to the clinic for these diseases.

Together, Agenus and AgenTus are uniquely positioned to develop optimal combination approaches that are affordable with checkpoint antibodies and cell therapy designed to deliver benefit to patients with cancer and COVID-19.

Our world-renowned scientists have published more than 100 peer-reviewed articles specifically in this field.

The advantages of our iNKT platform are summarized in the table below.

iNKT T cells NK cells γδ cells iPSCs/HSCs
Mechanistic Naturally allogeneic (no GVHD*) Depends on the cell differentiated into; lack natural education
Multiple cancer Killing mechanisms
Innate, rapid responders
Target, intratumoral myeloid cells
Operational Enhanced scale-up potential vs. T-cells
Built-in safety switch**

*GVHD: Graft vs. host disease

** iNKTs express a molecule known as invariant TCR (iTCR) at their cell surface. iTCRs are highly specific to iNKTs and are not expressed by normal tissue. In the theoretical event that iNKTs trigger severe adverse events in a patient, iTCR can be targeted with a specific antibody to kill iNKTs without killing healthy immune cells. AgenTus has IP rights over such an antibody
iPSC/HSC = Induced Pluripotent Stem Cells/Hematopoietic stem cells