On January 20, 2021 Celleron Therapeutics, the Oxford-based UK company developing novel medicines to treat cancer, reported that with its Chinese partner, Nuance Biotech Ltd, the company has received approval from the Chinese Center for Drug Evaluation for an IND registrational trial to develop CXD101 in patients suffering from peripheral T-cell lymphoma (PTCL) (Press release, Celleron, JAN 20, 2021, View Source [SID1234574127]).

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Previously, a Phase I trial in multiple tumour types demonstrated that CXD101 has an acceptable safety profile, and a promising signal for efficacy was observed in multiple tumour types, which led to the grant of EU Orphan Drug Designation in PTCL. A bridging study conducted in Hong Kong began in 2020 to evaluate the safety and pharmacokinetics in Chinese patients with multiple tumour types.

A Chinese Investigational New Drug (CIND) application is intended to support a Chinese New Drug Application (NDA) leading to marketing approval for the drug. This has now been approved by the Center for Drug Evaluation (CDE), which opens the way for Celleron and Nuance to the roll out a Phase Ib/II clinical trial in PTCL commencing late 2021.

Under the terms of the partnership agreements, Nuance Biotech received a license to develop and commercialise Celleron CXD101, in indications of high unmet medical need, in return for significant royalties and milestone payments relating to the development and commercialization of the products in China.

Professor David Kerr, Chief Medical Officer of Celleron Therapeutics, commented "This is a major milestone in the development of CXD101, which we know to be active in diverse lymphomas. We look forward to beginning the trial and working with Nuance in deploying CXD101 in China".

Professor Nick La Thangue, Chief Executive Officer of Celleron Therapeutics, commented "Approval from the Chinese CDE for this trial is a massively important step in continuing the successful growth of Celleron Therapeutics as a commercially focused cancer company".