Preclinical Study Finds Nanotrastuzumab to be Comparable with Herceptin HYLECTA

The nanoparticle suspension formulation was found to mirror the reference product closely in terms of AUC, Cmax, and Tmax across a 21-day Göttingen minipig study performed by Charles River Laboratories.

Medicine performance-enhancing company, Nanoform, has revealed that the tolerability and pharmacokinetics of Nanotrastuzumab match the performance of Herceptin HYLECTA. The comparability of the two formulations has been demonstrated in a preclinical 21-day study, the results of which the company announced in a Feb. 12, 2026 press release (1).

“This study is the first to directly compare the performance of a nanoparticle suspension with a hyaluronidase-enabled formulation. We thank Business Finland for their support in enabling this research,” said Prof. Edward Hæggström, CEO of Nanoform in a company press release (1).

“Combined with the building evidence from successful in-vivo studies by our customers, this read-out is an important signal for all companies developing subcutaneous antibody products,” commented Christian Jones, Chief Commercial Officer, Nanoform, in the press release (1). “A hyaluronidase-free, non-aqueous nanoparticle suspension enables a route that could simplify the product architecture and potentially widen optionality across lifecycle management, combination strategies, and self-administration concepts. We see this as a meaningful de-risking step for programs seeking more control over their formulation and delivery roadmap.”

“Most pharmaceutical and biotech companies developing antibody products are currently without a technology that can enable a subcutaneous version of their product,” stated Peter Hänninen, Chief Development Officer, Nanoform, in the press release (1). “We see a tremendous opportunity to work together with those drug developers to enable best-in-class subcutaneous versions.”

While subcutaneous injections are a preferable delivery route — not least for patient convenience but also for reduce cost and healthcare burden — many biological drugs are constrained to be delivered via intravenous infusion, owing to a variety of factors, including limited availability of enabling delivery technologies. Nanotrastuzumab is a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab — a targeted monoclonal antibody (mAb) therapy indicated for the treatment of certain human epidermal growth factor receptor 2 (HER2) breast and stomach cancers — that can be delivered subcutaneously (2).

“Using our proprietary Nanoform Biologics platform, we created nanotrastuzumab, a high concentration formulation of trastuzumab that enables subcutaneous injections, instead of intravenous administration, at more than 400 mg/mL. This innovation marks a significant step forward in patient-centric care, enabling a simple, hyaluronidase-free subcutaneous injection of a full dose in a single 2 mL syringe,” explained Hæggström, in a company press release about the development of nanoformed trastuzumab (2). “Nanotrastuzumab serves as the proof-of-concept for Nanoform’s proprietary high-dose mAb platform, and we remain committed to collaborating with global pharmaceutical partners seeking to realize the full value of SubQ [subcutaneous] formulations for mAbs and other biologics.”

References

1. Nanoform. Nanoform — Subcutaneously Administered Nanotrastuzumab Matches Performance of Herceptin Hylecta in Minipig Study. Press Release, Feb. 12, 2026.

2. Nanoform. Development of Nanoformed Trastuzumab for Subcutaneous Injection to be Presented at DDF Summit in Berlin. Press Release, June 3, 2025.