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NeuClone Announces Positive Preclinical Results for Stelara® Biosimilar Candidate

• NeuClone's biosimilar candidate for Stelara® (ustekinumab) shows comparable 3D structure to the reference product through X-ray crystallography. • The structural confirmation supports NeuClone's 'Right from the Start®' approach, ensuring high similarity to the original biologic from early development stages. • Clinical trials for the Stelara® biosimilar, developed in partnership with Serum Institute of India, are planned to begin in 2019. • Stelara®, a monoclonal antibody targeting IL-12 and IL-23, had global sales of $4.0 billion in 2017 and is used to treat conditions like plaque psoriasis and Crohn's disease.

NeuClone, a biopharmaceutical company, has announced positive preclinical results for its biosimilar candidate to Stelara® (ustekinumab), including 3-dimensional (3-D) structural confirmation via X-ray crystallography. The data confirm the identity and structural integrity of NeuClone's biosimilar, mirroring the reference product Stelara® in both primary amino acid sequence and 3-D folding.

Structural Similarity Confirmed

X-ray crystallography results demonstrated that NeuClone's biosimilar maintains the same structural integrity as Stelara®. This structural similarity is crucial for ensuring comparable efficacy and safety profiles, a key requirement for biosimilar approval.

Right from the Start® Approach

Dr. Noelle Sunstrom, CEO of NeuClone, stated, "These results validate our Right from the Start® approach to biosimilarity, demonstrating that NeuClone products are indistinguishable from their originator from the outset. Our ability to conduct crystallography, functional cell-based assays, and other Tier-1 biosimilarity tests in-house allows us to select the right candidate for clinical development."

Development and Clinical Plans

The Stelara® biosimilar is being developed in partnership with the Serum Institute of India. Production scale-up is underway, with Phase I clinical trials planned for 2019. This biosimilar is the company's second product to enter clinical trials in Australia, following their Herceptin® biosimilar.

The Importance of Analytical Data

Regulatory approval of biosimilars requires extensive analytical data to demonstrate structural and functional characterization comparable to the reference product. Techniques like X-ray crystallography are fundamental in establishing biosimilarity.

Market Context

Stelara®, marketed by Janssen (a Johnson & Johnson subsidiary), is a monoclonal antibody targeting both interleukin-12 and interleukin-23. It is currently approved for the treatment of several diseases, including plaque psoriasis and Crohn's disease. In 2017, Stelara® achieved global sales of $4.0 billion, with projections estimating sales of $4.9 billion in 2022.
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Reference News

[1]
NeuClone gibt präklinische Ergebnisse von Biosimilar-Kandidaten für Stelara® (Ustekinumab) bekannt
prnewswire.com · May 10, 2018

NeuClone announced positive preclinical results for its Stelara® biosimilar, confirming structural integrity via X-ray c...

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