InnoCare Pharma has received clearance for an investigational new drug application to conduct a clinical trial of ICP-248 plus orelabrutinib in China for lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).

The randomised, multicentre, controlled, open-label trial will assess the combination regimen as a first-line treatment for treatment-naive patients with chronic CLL/SLL.

It will assess the safety and efficacy of the combination treatment against immunochemotherapy.

ICP-248 is an orally bioavailable, B-cell lymphoma-2 (BCL2)-selective inhibitor while orelabrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor.

ICP-248 is intended to treat hematologic malignancies either as a standalone treatment or along with other therapies.

BCL2, a key regulatory protein of the apoptosis pathway, is often abnormally expressed in various hematologic malignancies. ICP-248 aims to counteract this by selectively inhibiting BCL2 and reinstating the natural process of programmed cell death.

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The initial data of ICP-248 have shown promising efficacy and safety profiles.

Orelabrutinib is an approved therapy for three lymphoma-related indications in China and Singapore. It has been included in China’s National Reimbursement Drug List.

Relapsed/refractory CLL/SLL patients treated with orelabrutinib in prior studies had experienced an overall response rate and complete response rate of 93.8% and 30%, respectively.

InnoCare Pharma co-founder, chair, and CEO Dr Jasmine Cui said: “InnoCare has developed strong pipeline in haemato-oncology that covers a variety of important haemato-oncology targets, including BTK, BLC2, CD19, CD20xCD3, and E-3 ligase.

“ICP-248 and orelabrutinib are important global assets of our company in the field of haematology, with multiple clinical studies conducted in China and the United States. We will accelerate clinical development and look forward to providing CLL/SLL patients with more efficient and safe treatment options.”

In December, the company reported positive topline data from the Phase II clinical trial of ICP-332 to treat atopic dermatitis.

The randomised, double-blind, placebo-controlled Phase II trial investigated the safety, efficacy, and pharmacokinetics of ICP-332 in 75 patients with moderate-to-severe atopic dermatitis.