Celleron Therapeutics’ CXD101 shows promising clinical results in its China IND programme with partner Nuance Biotech

On July 6, 2021 Celleron Therapeutics, the UK-based company developing novel medicines for cancer patients, reported encouraging early clinical data from its Hong Kong Phase I study to develop CXD101 in patients suffering from peripheral T-cell lymphoma (PTCL), a rare type of blood cancer (Press release, Celleron, JUL 6, 2021, View Source [SID1234584614]).

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Previously, a Phase I trial in multiple tumour types conducted in the UK demonstrated that CXD101 has an excellent safety profile. A promising signal for efficacy in multiple tumour types was observed, which led to the grant of EU Orphan Drug Designation in PTCL.

The current Phase I bridging study conducted in Hong Kong is evaluating the safety and pharmacokinetics in Chinese patients with a range of tumour types which have progressed despite multiple previous chemotherapy treatments. Together with the approved Chinese IND application, the current results open the way for the roll out of a Phase II clinical trial commencing late 2021. Preliminary imaging measurements of tumour size indicated that all patients in the first cohort showed a response, with one patient demonstrating a complete clinical response.

Professor David Kerr, Chief Medical Officer of Celleron Therapeutics, commented: "This is an important step forward in the development of CXD101 for Chinese patients. We know that the drug is clinically active in a range of haematological malignancies which are resistant to conventional chemotherapy from earlier studies conducted in the UK. Even at this early stage, the pattern of response appears to be similar in the Hong Kong study. These are important and encouraging results which endorse our Chinese drug development strategy".