The US Food and Drug Administration (FDA) has granted clearance for SIRPant Immunotherapeutics’ investigational new drug (IND) application enabling initiation of a first-in-human Phase I clinical trial of SIRPant-M to treat relapsed refractory non-Hodgkin lymphoma.

SIRPant plans to conduct this multi-centre study in the third quarter across five sites in the US.

Patients with relapsed refractory non-Hodgkin lymphoma will be administered with SIRPant-M, an autologous SIRPαlow activated macrophage immunotherapy to treat aggressive tumours.

SIRPant R&D vice-president Nathanael McCurley said: “Leveraging recent findings in macrophage biology, we developed a first-in-class cell therapy, SIRPant-M, to initiate adaptive immune responses against cancerous cells without requiring prior cancer-associated antigen identification.

“SIRPant-M employs a proprietary cocktail, PhagoAct, to license macrophages to drive tumour neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously.”

SIRPant-M also brings in long-lasting polyclonal immune memory against cancer by mobilising the cellular as well as humoral arms of the immune system.

The company also plans to file a second IND for SIRPant-M to treat solid tumours, initially targeting head and neck cancers.

SIRPant president and CEO Robert Towarnicki said: “This initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens.”