Subcutaneously Administered Nanotrastuzumab Matches Performance Of Herceptin HYLECTA In Minipig Study

Helsinki, Finland – Nanoform Finland Plc, the medicine performance-enhancing company, today announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotratsuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA™ ¹, a co-formulated product with Halozyme’s proprietary hyaluronidase enzyme marketed by Roche/Genentech.

Subcutaneous delivery of monoclonal antibodies, and other biological drugs, is the preferred delivery route due to patient convenience and healthcare system savings benefits. Limited availability of enabling delivery technologies has to-date constrained most biological drugs to be delivered as intravenous infusions. Nanoform’s proprietary particle engineering technology enables ultra-high concentration suspensions that may allow a substantial part of the biologics market to transition to subcutaneous and at-home delivery for patients.

• Preclinical results compared Nanotrastuzumab, a hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery, with Herceptin HYLECTA™.
• In a 21-day Göttingen minipig study run by Charles River Laboratories, Nanotrastuzumab’s AUC, Cmax and Tmax closely mirrored the reference product by Genentech / Roche. Nanotrastuzumab was well tolerated, supported by pathological, clinical and immunological readouts.
• Nanoform believes the data indicates that reference-like SC exposure may be achievable without hyaluronidase, expanding options for developers constrained by formulation, device, or IP/partnering considerations.

“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.

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.”

Peter Hänninen, Chief Development Officer: “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.”

[1] Herceptin HYLECTA™ is a trademark of Genentech Inc.

For further information, please contact:
Christian Jones, CCO
Christian.jones@nanoform.com
+44 7804 474 771

For investor relations queries, please contact:
Henri von Haartman, Director of Investor Relations
hvh@nanoform.com
+46 7686 650 11

About Nanoform

Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services, from pre-clinical to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: DNB Carnegie Investment Bank AB, +46 8 588 685 70, certifiedadviser@dnbcarnegie.se. For more information, please visit www.nanoform.com.