Milestone marks the transition of Low Dose IL-2 from clinical development to a scalable, regulatory-ready commercial manufacturing process
Strategic step strengthens supply chain resilience, expands production capacity, and advances readiness to meet potential patient demand
ARScience Biotherapeutics (“ARScience”), a clinical-stage biotechnology company specialising in developing and manufacturing customised interleukins for in vivo use, today announced the formal initiation of a commercial technology transfer for low-dose Interleukin-2 (LD IL-2). This milestone marks the transition of the LD IL-2 manufacturing process from clinical-stage production to a commercial-scale, cGMP-ready facility.
The technology transfer encompasses the systematic handover of manufacturing processes, analytical methods and process know-how from the current clinical supply facility to a commercial-scale site. This work will establish a robust, scalable cGMP manufacturing framework for LD IL-2, partnered with Coya Therapeutics, for the treatment of ALS and other neurodegenerative diseases.
“The initiation of this technology transfer represents a defining moment for ARScience. This milestone is not only a validation of our platform, it is a commitment to the patients who stand to benefit from LD IL-2, and we are fully dedicated to delivering a commercial-ready process that meets the highest regulatory standards,” said Dr. Gustavo Mahler, Chief Executive Officer of ARScience Biotherapeutics.
ARScience expects the technology transfer to be substantially complete and the commercial manufacturing process fully qualified by Q4 2027.
About ARScience Biotherapeutics
ARScience Biotherapeutics is a clinical-stage biotechnology company headquartered in Boca Raton, Florida, that specialises in developing and manufacturing customised interleukins for in vivo use. The Company’s mission is to expand the boundaries of immunotherapy through tailored cytokine solutions, driven by a passion to better serve the needs of patients. ARScience offers customised formulations and doses of its industry-leading interleukins to meet each patient’s unique therapeutic needs, recognising that impactful therapies must be as individual as the patients they treat.
The Company’s product pipeline includes ARS02, a subcutaneous low-dose IL-2 program in IND for neurodegenerative conditions; ARS02C, a Treg-based combination therapy across multiple therapeutic areas; ARS15, an IL-15 program at First-in-Human stage for solid tumours; and ARS10, an IL-15 fusion protein in preclinical development for cancer. ARScience brings over 30 years of cytokine expertise, cGMP manufacturing capabilities, and more than 60,000 doses of commercial/clinical-grade IL-2 injected in patients, backed by strong partnerships with leading academic institutions and clinical groups.
For more information, visit www.arsciencebio.com or contact info@arsciencebio.com.
