On May 1, 2023 SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company’s lead product candidate, SIRPant-M, an autologous SIRPαlow activated macrophage therapy for the treatment of aggressive tumors SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for the Company’s lead product candidate, SIRPant-M, an autologous SIRPαlow activated macrophage therapy for the treatment of aggressive tumors (Press release, SIRPant Immunotherapeutics, MAY 1, 2023, View Source [SID1234630802]). Under this IND, SIRPant intends to initiate its Phase 1, first-in-human, multi-center study in patients with relapsed refractory non-Hodgkin lymphoma in Q3.

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"This is a major accomplishment for the company and an important step forward in the clinical evaluation of SIRPant-M for the treatment of multiple tumor types," said Robert Towarnicki, President & CEO. "This initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens. There remains a significant unmet need in this setting, and we are excited to try and fill this need by treating with SIRPant-M."

SIRPant anticipates following this initial IND with a second IND for SIRPant-M focused on solid tumor treatments, initially targeting head & neck cancers. In preclinical testing, SIRPant-M has shown effectiveness against a wide variety of solid tumors in vivo, in addition to compelling positive data in hematological tumors.

"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" notes Nathanael McCurley, PhD, Vice President, R&D. "SIRPant-M employs a proprietary cocktail, PhagoAct, to license macrophages to drive tumor neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously." By mobilizing both the cellular and humoral arms of the immune system, SIRPant-M yields long-lasting polyclonal immune memory against cancer.

The company anticipates conducting the planned clinical trial at five sites across the United States. Register for company updates regarding initiation and recruiting as the sites come online at View Source." target="_blank" title="View Source." rel="nofollow">View Source Under this IND, SIRPant intends to initiate its Phase 1, first-in-human, multi-center study in patients with relapsed refractory non-Hodgkin lymphoma in Q3.

"This is a major accomplishment for the company and an important step forward in the clinical evaluation of SIRPant-M for the treatment of multiple tumor types," said Robert Towarnicki, President & CEO. "This initial study will enroll relapsed refractory non-Hodgkin lymphoma patients who are ineligible for or previously failed approved therapeutic regimens. There remains a significant unmet need in this setting, and we are excited to try and fill this need by treating with SIRPant-M."

SIRPant anticipates following this initial IND with a second IND for SIRPant-M focused on solid tumor treatments, initially targeting head & neck cancers. In preclinical testing, SIRPant-M has shown effectiveness against a wide variety of solid tumors in vivo, in addition to compelling positive data in hematological tumors.

"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" notes Nathanael McCurley, PhD, Vice President, R&D. "SIRPant-M employs a proprietary cocktail, PhagoAct, to license macrophages to drive tumor neo-antigen-specific polyclonal T cell and antibody responses, thus targeting cancer cells through multiple avenues simultaneously." By mobilizing both the cellular and humoral arms of the immune system, SIRPant-M yields long-lasting polyclonal immune memory against cancer.

The company anticipates conducting the planned clinical trial at five sites across the United States. Register for company updates regarding initiation and recruiting as the sites come online at View Source