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.

June 15, 2026
June 16, 2026 - As Georgia Life Sciences concludes the 2025-2026 cycle of the Biotech Teacher Training Initiative (BTTI), the results reinforce the critical role educators play in building the state's future life sciences workforce. Since July of 2025, BTTI engaged 98 educators representing 40 schools across 23 school systems, reaching an estimated 5,375 students through hands-on biotechnology instruction, career-connected learning, and industry-relevant classroom experiences. The Georgia Life Sciences Equipment Depot further expanded the program's impact by supporting 238 teachers with access to laboratory equipment and materials that make authentic life sciences learning possible. Georgia Life Sciences is also pleased to report that funding for BTTI was maintained in the Georgia House version of the FY 2027 budget approved earlier this year. The upcoming 2026-2027 program cycle will mark an important evolution for BTTI. Building on feedback from industry partners and workforce trends across the life sciences sector, Georgia Life Sciences will expand the program's scope to better reflect the skills and competencies employers increasingly need. In addition to foundational biotechnology concepts, future programming will be organized around key industry domains, including Quality Assurance and Quality Control (QA/QC), Research & Development (R&D), MedTech, Artificial Intelligence, Automation, and Advanced Manufacturing. This expanded approach will provide educators with greater insight into the breadth of career opportunities available across Georgia's life sciences ecosystem while helping students develop awareness of the technologies and disciplines shaping the industry's future. The impact extends far beyond individual workshops, creating lasting connections between Georgia classrooms and the state's growing life sciences ecosystem while helping build the talent pipeline that will power Georgia's future innovation economy. "Before BTTI, I was hesitant to do biotech labs because they seemed too complex and expensive," shared Josephine Jeganathan of Stockbridge High School. "The program showed me how simplified it can be and provided the equipment and materials needed to successfully implement the Central Dogma Lab with all my classes." Teachers are also seeing increased student engagement through hands-on learning experiences. Tonie Curry of North Clayton High School used a chromatography lab to connect environmental science concepts to water pollution and sustainability. "Students were highly interested in seeing how substances separated and made strong connections to water pollution and environmental sustainability," Curry noted. "The hands-on nature of the lab encouraged curiosity and deeper understanding." For many educators, one of the most valuable aspects of the program is the connection between classroom learning and real-world careers. As Marshai Waiters of Marietta Middle School reflected: "Exposure is key. There are so many avenues to work in STEM, and they are all accessible with opportunity and knowledge. The insights gained from industry speakers will inform my teaching and create new opportunities for student exposure." When teachers are trained, equipped, and connected to industry, students gain more than a science lesson—they gain a window into Georgia's life sciences future.
June 10, 2026
In recent comments to the Department of Justice (DOJ) and Federal Trade Commission (FTC), PULSE highlighted critical reforms to ensure that U.S. competition policies support – and do not impede – the pro-competitive mergers and acquisitions (M&A) and other collaborations that drive American life sciences innovation. PULSE submitted comments in response to two joint DOJ/FTC Requests related to Guidance on Collaborations Among Competitors and Improvements to the Premerger Notification and Report Form (HSR Form). Read below for key takeaways from PULSE’s comment letters: 1. Life Sciences Innovation Depends on Collaboration “At its core, life sciences innovation is overwhelmingly collaborative. The cutting-edge medicines and cures developed by America’s life sciences industry are rarely the result of just one sole actor. Instead, they more often emerge from a calibrated sequence of partnerships… that collectively usher a biomedical breakthrough from early-stage discovery to FDA approval and delivery to patients.” – PULSE, Comments on Guidance on Collaborations Among Competitors 2. Policies that Ignore the Fundamental Role of Life Sciences M&A Risk Chilling Innovation for Patients “Against the significant challenges and pressures inherent to life sciences innovation, such policies that needlessly delay pro-competitive transactions have significant ripple effects: eroded investment incentives, disruptions in the path to launch and, ultimately, slowed or stalled development of new treatments and cures for patients.” – PULSE, Comments on Improvements to the HSR Form 3. Clear, Predictable Standards Can Support Competition and Innovation in America’s Life Sciences Ecosystem “Preserving clear and workable pathways for collaboration is therefore essential to sustain the broader ecosystem that delivers innovation and sustains America’s status as the world leader in life sciences innovation.” – PULSE, Comments on Guidance on Collaborations Among Competitors Leading business and industry organizations echoed and reinforced these priorities. Their comments highlight the unique market dynamics of life sciences innovation and the importance of collaboration and M&A – particularly with respect to early-stage R&D. “Because drug development typically takes over a decade, and the vast majority of drugs in development never make it to market, the antitrust risks associated with R&D collaborations in this space may be less than with other R&D collaborations.” – ABA Antitrust Law Section, Comments on Guidance on Collaborations Among Competitors “In the biopharmaceutical sector, for instance, R&D ventures in the pre-clinical or Phase I stages should be presumed lawful. At these early stages, about 90% of drugs never make it to market, so these collaborations are far too distant from commercialization to pose a meaningful threat to competition.” – U.S. Chamber of Commerce, Comments on Guidance for Collaborations Among Competitors “Healthy M&A activity also aids company formation and capital raising earlier in a business’s life cycle, as entrepreneurs and early-stage investors often depend on M&A for an exit opportunity. Conversely, discouraging business combinations by imposing burdensome one-size-fits-all standards on all transactions, like those imposed by the 2024 amendments, would disincentivize early-stage innovation and slow down economic growth.” – National Association of Manufacturers, Comments on Improvements to the HSR Form The bottom line: A balanced approach to antitrust enforcement policy should support life sciences M&A and other collaborations, ensuring new medicines continue to reach patients, while preserving a diverse and collaborative ecosystem. PULSE urges the agencies to adopt clear, workable and predictable standards that companies can apply with confidence. That includes preserving enforcement safety zones for low-risk, pro-competitive collaborations, as well as ensuring the HSR Form facilitates a timely, focused and fit-for-purpose screening process for life sciences M&A deals. Click below to read PULSE’s full comments: PULSE Comments on Guidelines on Collaborations Among Competitors PULSE Comments on Improvements to the HSR Form Source: PULSE Urges FTC, DOJ to Support Pro-Competitive Life Sciences Collaborations and M&A - Partnership for the U.S. Life Science Ecosystem (PULSE)
June 5, 2026
 June 5, 2026 - Georgia Life Sciences is pleased to announce the promotion of Stacey Bowlin to Executive Vice President . Since joining Georgia Life Sciences in 2024, Stacey has played a central role in advancing the organization’s strategic visibility, industry partnerships, membership growth, and statewide engagement. Her leadership has helped strengthen Georgia Life Sciences’ position as a leading voice for Georgia’s biotechnology, pharmaceutical, medical device, diagnostics, and digital health sectors. “Stacey has made an extraordinary impact on Georgia Life Sciences in a very short period of time,” said Maria Thacker Goethe, President & CEO of Georgia Life Sciences . “She successfully led our transformation from Georgia Bio to Georgia Life Sciences, helping modernize our brand and better reflect the full breadth of Georgia’s life sciences industry. She has also strengthened our member recruitment and retention strategy, deepened engagement across the ecosystem, and brought a level of operational discipline that has helped position the organization for continued growth. I am thrilled to recognize Stacey’s leadership and contributions with this well-deserved promotion to Executive Vice President.” In her expanded role, Stacey will continue to lead key areas of organizational strategy, operational execution, member engagement, and long-term growth. She will work closely with the CEO to support financial and organizational performance, oversee key initiatives, and help translate Georgia Life Sciences’ long-term vision into actionable strategies that strengthen the state’s life sciences ecosystem. With more than two decades of experience in strategic engagement, marketing, operations, and industry development, Stacey brings a collaborative, mission-driven approach to leadership that aligns closely with Georgia Life Sciences’ vision for the future.
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