The trial is being led by Dr Koen van Besien at Weill Cornell Medical College/New York-Presbyterian Hospital, said the company.
The US Food and Drug Administration (FDA) cleared the investigational drug in June this year for the treatment of COVID-19 patients. The allogeneic [off the shelf] iNKT cell therapy targets patients with moderate to severe COVID-19.
The FDA has also cleared agenT-797 to treat patients with cancer, with a trial in this respect set to start at the Dana Farber/Harvard Cancer Center next month. The company maintains that iNKTs can penetrate tissues, giving them a critical advantage in targeting solid tumors not currently served by approved cell therapies.
When asked how is it that iNKT cell therapy can treat COVID-19 and cancer patients, Jennifer Buell, president and COO, Agenus, told BioPharma-Reporter:
“Invariant natural killer T cells (iNKT cells) are a unique cell type that combine features of two critical arms of the immune system, T cells (adaptive immunity) and NK cells (innate immunity), making them invaluable in combatting diseases like cancer and COVID-19.
“In the case of cancer, they travel to tumor tissue by detecting a protein known as CD1d. They also express a protein known as NKG2D, which recognizes tumor stress ligands. Importantly, these proteins are expressed in both solid and liquid tumors, making iNKT cells broadly applicable to all cancer patients. In preclinical models, iNKT cells have been shown to work alone and have also demonstrated curative potential when activated and combined with Agenus’ pipeline of immuno-oncology drug candidates.”
She said that Agenus has observed that the number of iNKT cells in the body is reduced in people with cancer and infectious diseases like COVID-19, and this reduction is associated with poorer response to disease.
“In preclinical models that bear similarities to SARS-COV-2, increasing the number or frequency of iNKT cells reduced viral shedding and prevented inflammation-driven lung injury. The mechanism is based on the induction of innate and adaptive immunity. These specific attributes are of paramount importance in any therapy attempting to overcome COVID-19.”
AgenTus also has access to Agenus’s portfolio of checkpoint antibodies and cancer vaccines which are said to allow for optimal combinations with its cell therapies; Agenus said that gives its subsidiary flexibility to develop effective combinations with curative potential for patients with cancer and infectious disease at a significant cost advantage.
On that point, Buell said Agenus has delivered more than 15 new discoveries into the clinic, which include antibodies that are designed to build and expand innate and adaptive immunity.
Agenus’ various investigational immuno-oncology therapies are designed to:
- Increase the number of immune fighting T cells (anti-CTLA-4, anti-CD137)
- Block tumor induced immune suppression (anti-PD-1)
- Boost multiple immune fight cells (TIGIT mono and bispecific)
- Deplete regulatory T cells from the tumor microenvironment (AGEN1223, AGEN1181) and
- Modulate the tumor microenvironment to suppress tumor growth (iNKTs, AGEN1531).
