HUMMELSTOWN, Pa.–(BUSINESS WIRE)–SIRPant Immunotherapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced 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. 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 https://sirpantimmunotx.com/contact/.
About SIRPant Immunotherapeutics, Inc.
SIRPant, a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, is initially addressing the development of novel autologous macrophage cell therapy for treatment of aggressive cancers of unmet medical need. The company believes its proprietary technologies for empowering patient innate and adaptive immune responses against cancer will play a leading role in the next generation of successful treatments. For more information, please visit www.sirpantimmunotx.com.
This press release contains certain “forward-looking statements” concerning the development of SIRPant Immunotherapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. SIRPant Immunotherapeutics undertakes no obligation to update any forward-looking statements for any reason.