Immuno-oncology company Alexo Therapeutics has started dosing patients in the Phase I clinical trial of a fusion protein ALX148 for the treatment of solid tumours and lymphoma.
ALX148 contains a high-affinity, CD47 binding domain of SIRPα linked to human immunoglobulin's inactive Fc region.
By selectively binding to CD47, ALX148 blocks its interaction with SIRPα, resulting in the inhibition of an immune checkpoint mechanism used by tumour cells.
The two-part Phase I trial is designed to assess the safety, pharmacokinetics and pharmacodynamics of ALX148 in advanced / metastatic solid tumours and relapsed or refractory non-Hodgkin lymphoma patients.
Alexo president and chief executive officer Jaume Pons said: “The initiation of our first clinical trial for ALX148 marks an important milestone in the company’s development.
“Targeting CD47-SIRPα has broad therapeutic potential across many types of cancer. ALX148 is designed to enhance the efficacy of antibody-based therapies and has demonstrated excellent efficacy and safety in preclinical studies.
"We believe that Alexo’s approach of targeting the CD47 pathway using ALX148 will selectively eliminate tumour cells while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic.”
In the dose escalation part, ALX148 will be given as a single-agent, while the combination therapy part will see the administration of the fused protein with approved anti-cancer antibodies.
The preclinical studies showed significant tumour growth inhibition by the combination of ALX148 with targeted anti-cancer antibodies and checkpoint inhibitors.