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.

UGA & Manus Among Awardees in $214M BioMADE Investment

April 30, 2026
BioMADE Announces $21.4 Million Invested in 14 Projects to Develop the U.S. Bioindustrial Manufacturing Industry and Advance National Security Priorities

Nutrivert announces first close on $6 million Series A-2 funding round

April 17, 2026
April 17, 2026 - Nutrivert Inc., a developer of non-antibiotic replacements for antibiotic growth promoters in livestock, today announced it has completed the first close, raising $2.375 million, of its Series A-2 funding round of $6 million. The round was led by global animal health investor Arrow Ventures with participation from other investors. The funding will be used to further develop Nutrivert’s manufacturing, human food safety and target animal safety and efficacy packages for the company’s lead product Nutrivert LDPP. Nutrivert LDPP is a proprietary, novel, orally available, lipidated synthetic enantiomeric desmuramyl analog of muramyl dipeptide, the smallest conserved immunoactive component of bacterial peptidoglycan. LDPP has no antibacterial effect but has consistently promoted growth and improved feed efficiency in pig studies. LDPP binds to the mammalian NOD2 receptor and is the only NOD2 ligand reported to inhibit the inflammatory signal NF-κB. In pilot studies, LDPP rescued 70kg pigs from an otherwise lethal dose of porcine reproductive and respiratory syndrome virus (PRRSV) and abrogated influenza disease symptoms in piglets. The Company intends to develop LDPP for all major livestock species worldwide. Patents have been granted in most major markets. The global antibiotic growth promoter market is worth an estimated $5.8 billion. Approximately 73% of all antibiotics are fed to livestock. The market is believed to be the world’s largest drug market by volume, with ~100,000 tons of active pharmaceutical ingredient administered annually. FDA’s latest data, for 2024, show a 13% rise in U.S. livestock antibiotic use since 2017. The Food and Agriculture Organization reports that livestock antibiotics are mostly given to speed animal growth. Regulators and non-governmental organizations have called for reduction of antibiotic use in livestock, citing concerns that the global, intensive use of antibiotics, often at subtherapeutic doses, selects for antimicrobial resistance: bacteria that are “immune” to antibiotics and that therefore pose a threat to public health. Spillovers of antibiotic-resistant bacteria from livestock to humans have been documented. “Nutrivert LDPP has consistently improved feed efficiency in pigs without antibiotics,” said Bernhard Kaltenboeck, CSO. “We are excited to have the support of Arrow Ventures and our other investors in bringing a new tool that will help producers reduce production costs and reduce selection pressure for antimicrobial resistance.” About Nutrivert LDPP: LDPP is an investigational compound currently undergoing clinical evaluation. It has not been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other global regulatory authority for any indication. The safety and efficacy of LDPP have not been established. Any mention of potential use is based on preliminary data and does not guarantee future regulatory clearance or commercial availability.

USDOL Approves National Biomanufacturing Technician Standards

April 16, 2026
[Seattle, WA] April 15, 2026 – Apprenti, the leading national intermediary for Registered Apprenticeship (RA), is proud to announce the formal approval and filing of the National Biomanufacturing Technician Standards with the U.S. Department of Labor (USDOL). Crafted under the strategic guidance of the Apprenti Life Science Advisory Board—which includes leaders from Pfizer, Merck, Thermo Fisher, and Biogen—these standards were developed in close partnership with the Life Sciences Workforce Collaborative (LSWC) and InnovATEBIO as part of a high-impact NIIMBL project. This approval represents a foundational shift for the industry, moving away from a fragmented, state-by-state approach to a scalable, consistent model for developing biomanufacturing professionals at sites across all 50 states. The national standards provide a “plug-and-play” framework that ensures a technician trained in Massachusetts or North Carolina meets the same rigorous, industry-vetted benchmarks as one in Ohio or Missouri. The foundational development of these national standards was informed by existing Life Science RA programs from organizations across the country, including: MassBioEd, Oregon Life Sciences, National Center for Therapeutics Manufacturing (NCTM), BioSTL, Wistar Institute, North Carolina Life Sciences Apprenticeship Consortium (NCLSAC) and others. A National Engine for Talent: The filing of these standards is a cornerstone of NIIMBL’s efforts to strengthen domestic biomanufacturing capabilities and develop the workforce of the future. Beyond the standards themselves, the project is delivering a suite of resources and tools—including a comprehensive Employer Toolkit and specialized screening rubrics—that state-based organizations and employers can leverage to implement RA programming for their most in-demand roles. “These national standards set the stage for a sustainable, skills-first pipeline that mirrors the rigor of the industry’s most complex manufacturing processes,” said Daniel Weagle, Director of Life Science Business Development at Apprenti. “By providing a unified approach, we are empowering national employers to scale their workforce development efforts strategically and accessibly.” The Value Proposition of Registered Apprenticeship For Life Science employers, the Registered Apprenticeship model offers a compelling business case rooted in cost-effectiveness and long-term stability: High Retention: RA programs boast exceptional retention rates—historically as high as 89% to 90%—as apprentices are trained within a company’s specific culture and protocols from day one. Cost Efficiency: Research indicates that for every dollar spent on apprenticeship, employers see an average return of $1.47 in increased productivity and reduced recruitment costs. Inclusive Innovation: The model expands access to untapped talent pools, including non-degreed individuals and career-switchers, ensuring the biomanufacturing workforce reflects the demographics of the communities it serves. As the global biopharmaceutical market is projected to exceed $570 billion by 2032 , this partnership between Apprenti, NIIMBL, and industry leaders ensures that the U.S. workforce is not just prepared for the future of manufacturing, but is actively driving it. This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086). About Apprenti: Apprenti is a 501(c)(3) nonprofit organization and a U.S. Department of Labor recognized Intermediary. Apprenti designs and delivers scalable Registered Apprenticeship (RA) programs in high-demand industries. By adapting the proven apprenticeship model, Apprenti helps employers meet workforce needs while training the next generation of skilled professionals. Apprenti’s programs are industry-recognized, federally approved, and supports employers across the country. Since launching in 2015, Apprenti has partnered with employers, government agencies, and education providers to create new apprenticeship pathways. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of industry standards, and educate a world-leading workforce. Media Contact: Dan Maiese, Communications Manager, dmaiese@niimbl.org , 302-831-3824 About the Life Sciences Workforce Collaborative (LSWC) The Life Sciences Workforce Collaborative (LSWC) is a national nonprofit coalition of state, regional and national life science associations and institutes who are working together to build a competitive, and future-ready life sciences workforce. Originally founded in 2012 as the Coalition of State Bioscience Institutes (CSBI), LSWC connects industry, academia, and government partners through data-driven insights, best practice sharing, and collaborative programs. Learn more at www.LifeSciencesWorkforce.org About InnovATEBIO InnovATEBIO is a National Center for Biotechnology Education, working to advance the education of highly skilled technicians for the nation’s biotechnology workforce. Toward this goal, InnovATEBIO provides leadership in biotechnology technician education, including support for development and sharing of best practices and emerging technologies in biotechnology workforce development. Read LSWC's full announcement here.
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