Preclinical Study Finds Subcutaneous Nanotrastuzumab Comparable to Herceptin HYLECTA in Minipig Model

A preclinical study evaluating Nanoform’s nanoparticle-engineered formulation of trastuzumab demonstrated pharmacokinetic comparability and favorable tolerability relative to Herceptin HYLECTA in a 21-day Göttingen minipig model. The findings suggest that reference-like subcutaneous (SC) exposure may be achievable without the use of hyaluronidase, potentially expanding formulation and delivery flexibility for monoclonal antibody developers.

SC administration of biologics has gained traction due to patient convenience and potential healthcare system efficiencies. However, many monoclonal antibodies remain administered intravenously, in part due to technical constraints related to achieving sufficient drug concentration and tissue dispersion for SC injection. Herceptin HYLECTA, for example, incorporates Halozyme’s recombinant human hyaluronidase enzyme to facilitate SC delivery.

Nanoform’s investigational candidate, Nanotrastuzumab, is a hyaluronidase-free, non-aqueous nanoparticle suspension engineered to enable ultra-high drug concentration for SC administration.

What Did the Preclinical Study Assess?

The head-to-head study, conducted by Charles River Laboratories, evaluated tolerability and pharmacokinetics of Nanotrastuzumab compared with Herceptin HYLECTA in Göttingen minipigs over a 21-day period.

Key pharmacokinetic parameters—including area under the curve (AUC), maximum concentration (Cmax), and time to maximum concentration (Tmax)—were reported to closely align between the nanoformed trastuzumab suspension and the reference product. Pathological, clinical, and immunological assessments supported favorable tolerability of the nanoparticle formulation.

According to the company, the data indicate that SC exposure comparable to a hyaluronidase-enabled product may be achievable using a nanoparticle suspension approach alone.

“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.

Why Is Hyaluronidase-Free Delivery Significant?

Hyaluronidase-containing formulations have enabled SC delivery of several high-dose monoclonal antibodies by temporarily modifying the extracellular matrix to facilitate dispersion and absorption. However, reliance on enzyme-based delivery systems may introduce formulation complexity, device considerations, and intellectual property dependencies.

Nanoform’s particle engineering platform is designed to produce ultra-high concentration, non-aqueous suspensions that could allow certain biologics to transition from intravenous infusion to SC administration without enzyme co-formulation.

Christian Jones, Chief Commercial Officer, commented: “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. 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.”

What Are the Broader Development Implications?

The results may have implications for biologic developers seeking alternative pathways to SC delivery, particularly those constrained by existing formulation technologies or partnership arrangements tied to proprietary enzyme platforms.

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

While the findings are limited to a preclinical large-animal model, the pharmacokinetic alignment and tolerability profile support further investigation of nanoparticle-based SC antibody formulations. If confirmed in human studies, such approaches could broaden options for at-home administration, lifecycle management strategies, and delivery innovation across the monoclonal antibody landscape.

Reference

Nanoform - Subcutaneously Administered Nanotrastuzumab Matches Performance of Herceptin Hylecta in Minipig Study. News release. Nanoform. Published February 12, 2026. Accessed February 12, 2026.