The MHRA has given the green light to Faron to conduct the BEXMAB clinical trial in the UK. Credit: Andreas_Bergerstedt via Shutterstock.

Faron Pharmaceuticals is advancing its cancer immunotherapy programme in the UK, with the region’s regulatory authorities approving the advancement of its BEXMAB trial and granting its lead drug candidate Clevegen (bexmarilimab) an Innovation Passport designation. 

Clevegen, developed to treat relapsed or refractory myelodysplastic syndrome (r/r MDS), has been recognised under the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) Innovative Licensing and Access Pathway (ILAP). This framework is designed to accelerate patient access to new therapies addressing critical unmet medical needs. 

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The BEXMAB study (NCT05428969) is an open-label Phase I/II clinical trial evaluating the safety and efficacy of Clevegen in combination with the standard-of-care treatment, Bristol Myers Squibb’s (BMS’s) Onureg (azacitidine). The trial focuses on aggressive haematological cancers, including acute myeloid leukaemia (AML) and MDS. These malignancies are known for high levels of treatment resistance and poor clinical outcomes. 

Last week (27 November), Faron reported positive interim data from the Phase II portion of the ongoing BEXMAB trial. These interim results support findings from earlier phases, particularly in MDS patients who had previously failed treatment with hypomethylating agents (HMA). Among 20 such patients enrolled in the study, an objective response rate (ORR) of 80% was reported. These patients, who typically have limited treatment options, have showed an estimated median overall survival (mOS) of approximately 13.4 months. Faron said that this is a significant improvement compared to the historical mOS of five to six months under standard-of-care therapies. 

The full analysis will be presented at the 66th American Society of Hematology (ASH) Annual Meeting on 9 December 2024.  

Clevegen is a monoclonal antibody that targets Clever-1, a protein highly expressed in AML and MDS, which is linked to therapy resistance, impaired T cell activation, and limited overall survival. By directly inhibiting Clever-1, Clevegen is intended to reduce the replication of cancer cells, enhance antigen presentation, and boost the immune response.  

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HMAs like BMS’s Onureg (azacitidine) are often used as first-line treatments for MDS and AML. However some patients eventually relapse or are non-responsive to HMAs, which then leads to more advanced disease.  

According to a report on GlobalData’s Pharma Intelligence Center, there will be 107,397 diagnosed cases of MDS in 2028. GlobalData is the parent company of Pharmaceutical Technology. 

The US Food and Drug Administration (FDA) granted a fast track designation to Clevegen in August 2024. According to GlobalData’s Pharma Intelligence Center, Clevegen could pull in up to $397m in sales in 2030 if it secures approval.