SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-MTM for the Treatment of Solid Tumors

HUMMELSTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) — SIRPant Immunotherapeutics, Inc., a clinical-stage immuno-oncology company focusing on developing next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for the Company’s lead product candidate, SIRPant-M™, an autologous SIRPα low  activated macrophage therapy, to treat solid tumors. Eligible tumor types include, among others, head and neck cancer, non-melanoma skin cancers, bladder and kidney cancers, low-grade prostate cancer, triple-negative breast cancer and certain sarcomas. Earlier this year, the company cleared its first IND in Non-Hodgkin Lymphoma (NHL). 

“This second IND clearance in 2023 is a testimony not only to the SIRPant team’s ability to deliver on-time development milestones, but also to the broad potential scope of therapeutic opportunities for SIRPant-M TM  in multiple tumor types,” said Robert Towarnicki, President & CEO of SIRPant. “We look forward to progressing SIRPant-M TM  through clinical development and dosing the first patients in both the NHL and solid tumor trial in 2024.”

“A unique attribute of this IND is that it allows SIRPant-M™to be evaluated, in parallel, in both relapsed/refractory and pre-operative settings earlier in the disease trajectory,” said Jelle Kijlstra, MD, MBA, Chief Medical Officer of SIRPant. “Exploring SIRPant-M TM  in multiple therapeutic settings, in parallel rather than in sequence, allows for more expedient development as it enables us to establish more rapidly where this therapy has the highest potential in changing the lives of cancer patients.”

The Phase 1, multi-center clinical study is designed to evaluate the safety, determine the recommended dose for Phase 2, and assess preliminary anti-tumor activity in subjects with solid tumors that have progressed following available standard treatment, or for whom no standard treatment exists. Under the newly cleared IND, the Company plans to initiate clinical investigation of SIRPant-M TM  as a monotherapy and in combination with other immuno-stimulatory modalities such as radiotherapy and immune checkpoint inhibitors for the treatment of select solid tumor indications.
  
About SIRPant-M TM
SIRPant-M TM  is an autologous cancer-agnostic macrophage cell therapy manufactured using PhagoAct™, an advanced non-genetic method to activate and educate patients’ own macrophages for the recognition and elimination of cancerous cells. As a monotherapy or in combination with other immuno-stimulatory modalities such as radiotherapy and immune checkpoint inhibitors, SIRPant-M™acts by directly attacking cancerous cells, stimulating cancer neoantigen-specific cytotoxic T cells and antibodies, reducing immunosuppressive elements, and perpetuating a pro-inflammatory tumor microenvironment that favors cancer elimination. By mobilizing other immune cells and promoting a multi-prong attack on cancer, SIRPant-M™targets established tumors and achieves persistent and durable immune memory that resists cancer relapse. SIRPant-M™is currently recruiting patients for a Phase 1 trial for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (R/R NHL, SI-101).

About SIRPant Immunotherapeutics, Inc.
SIRPant Immunotherapeutics Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors. The cell therapy technology SIRPant employs is based on the reduction of SIRPα expression combined with activation of the patient’s own macrophages. This population of SIRPαlow activated macrophages are designed to attack the tumor following injection by activating the patient’s immune system to produce broad spectrum anti-tumor activity that utilizes patient T-cells and antibodies targeting cancer neoantigens. Because SIRPant does not genetically engineer its cell therapies, the company believes its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered cell therapies in the clinic, and may provide patients with meaningful clinical benefit. As a result, SIRPant-M TM  has a compelling product profile when compared to current gene-modified cell therapies. For more information, please visit  www.sirpantimmunotx.com.

Georgia Life Sciences Applauds Congressman McCormick for Introducing Federal Biotech Leadership Legislation

July 24, 2026
July 24, 2026, Atlanta, GA - Georgia Life Sciences applauds Congressman Rich McCormick (R-GA) for introducing the Biotechnology Diplomacy Leadership Act , legislation designed to strengthen America's leadership in biotechnology by establishing a senior biotechnology leadership position within the U.S. Department of State. As biotechnology continues to drive breakthroughs in healthcare, agriculture, advanced manufacturing, and national security, the United States must remain a global leader in innovation while strengthening strategic partnerships with allies around the world. The proposed legislation recognizes biotechnology as a critical component of U.S. economic competitiveness and foreign policy and would help ensure that the federal government is well positioned to advance these priorities internationally. The legislation also reflects recommendations from the National Security Commission on Emerging Biotechnology , which called for a more coordinated national approach to advancing biotechnology and protecting U.S. leadership in this strategically important sector. "Georgia is home to one of the nation's fastest-growing life sciences ecosystems, and policies that strengthen America's global biotechnology leadership directly benefit innovators, researchers, manufacturers, and patients," said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. "We appreciate Congressman McCormick's leadership in recognizing biotechnology as both an economic engine and a strategic national priority." Georgia Life Sciences looks forward to working with policymakers at both the federal and state levels to advance policies that foster innovation, strengthen the U.S. bioeconomy, and ensure America remains the global leader in biotechnology.

Georgia Life Sciences Names Renee' Martin, Ph.D., Program Manager to Lead Flagship Educator Workforce Development Program

July 21, 2026
Georgia Life Sciences names Renee Martin, Ph.D., to lead its Teacher Training Initiative, advancing educator workforce development and Georgia's future life sciences talent pipeline.

Georgia Life Sciences Partnership Expands Plant Biotechnology Education for Agriscience Teachers Across Georgia

July 17, 2026
FOR IMMEDIATE RELEASE  July 16, 2026 ATLANTA, Ga . – Eighteen Georgia high school agriscience teachers recently participated in a hands-on plant tissue culture training at Cedar Shoals High School in Athens, equipping educators with biotechnology skills and classroom resources that will expand access to experiential STEM learning for students across the state. Hosted through a partnership led by Georgia Life Sciences (GLS), the workshop was facilitated by Julie Throne, Agriscience Teacher, FFA Advisor, and CTAE Department Chair at Cedar Shoals High School. Participants received practical instruction in plant tissue culture techniques using newly developed portable tissue culture kits generously donated by California-based Athena Ag. Plant tissue culture is a foundational biotechnology technique used in agriculture and plant science research to propagate plants under aseptic conditions. By incorporating these concepts into agriscience classrooms, educators can provide students with hands-on experiences that introduce biotechnology while building technical skills relevant to careers in agriculture and biotechnology. As part of the workshop, each participating teacher received two complete plant tissue culture kits to take back to their school, enabling students throughout Georgia to engage in laboratory-based biotechnology activities and explore emerging career pathways in the life sciences. "Providing educators with access to industry-relevant training and classroom resources is one of the most effective ways to inspire the next generation of Georgia's life sciences workforce," said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. "Through partnerships like this, we're helping teachers bring real-world biotechnology into their classrooms while expanding opportunities for students to discover careers in one of Georgia's fastest-growing industries." The training is part of Georgia Life Sciences' broader Teacher Training Initiative, a statewide workforce development program that equips middle and high school educators with the knowledge, tools, and industry connections needed to deliver hands-on biotechnology instruction. Through strategic partnerships with industry, education, and nonprofit organizations, the initiative continues to strengthen Georgia's talent pipeline by connecting classroom learning with real-world workforce opportunities. Georgia Life Sciences extends its appreciation to Julie Throne for leading the training and to Athena for its generous donation of classroom kits, helping expand access to biotechnology education for educators and students across the state.
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