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 Designates City of Atlanta as Newest BioReady® Community

By Sheran Brown • February 21, 2025
Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

By Sheran Brown • February 20, 2025
A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries. PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition. The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions. The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

By Sheran Brown • February 20, 2025
The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions. ----------------------- “Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment. As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research. NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases. While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return. In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”
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