Alexo Starts Phase 1 Clinical Trial of ALX148 for Solid Tumors and Lymphoma

Alexo Starts Phase 1 Clinical Trial of ALX148 for Solid Tumors and Lymphoma

Alexo Therapeutics has begun dosing patients in a Phase 1 clinical trial designed to evaluate the characteristics in the body and the safety of the CD47 inhibitor ALX148 in patients with advanced solid tumors and lymphoma.

In a healthy organism, a CD47 protein at a cell’s surface helps protect cells that should be protected. Conversely, its absence leads to cell destruction by the scavengers of the immune system, macrophages, whose job is to eliminate dead and dying cells.

In a number of cancers, the body overproduces CD47. This prevents macrophages from eliminating cancer cells, enabling disease progression. Those cancers include lymphoma, leukemia, bone tumors, neuroblastoma, and children’s brain tumors.

Alexo developed ALX148 to block the CD47 checkpoint that cancer cells use to prevent the immune system from destroying them. ALX148 binds to CD47, preventing its interaction with SIRPα, a protein that regulates cell signaling.

ALX148 has shown promising results in pre-clinical trial studies. It inhibited tumor growth in combination with targeted anti-cancer antibodies and checkpoint inhibitors, while sparing healthy blood cells expressing CD47.

“The initiation of our first clinical trial for ALX148 marks an important milestone in the company’s development,” Jaume Pons, PhD, president and chief executive officer of Alexo, said in a press release. “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.”

The Phase 1 clinical trial (NCT03013218) will start with tests of increasing doses of ALX148 as a stand-alone therapy. Researchers will also test it in combination with approved anti-cancer antibodies. The antibodies will include either Tecentriq (atezolizumab), which has been authorized for treating certain patients with metastatic urothelial carcinoma or non-small cell lung cancer, or Herceptin (trastuzumab), which has been approved for breast cancer.

Alexo continues to recruit patients for the trial. It is looking for people with advanced/metastatic solid tumors and relapsed or refractory non-Hodgkin lymphoma. Non-Hogdkin lymphoma differs from Hodgkin lymphoma in that it lacks an abnormal cell called a Reed-Sternberg cell.

“We believe that Alexo’s approach of targeting the CD47 pathway using ALX148 will selectively eliminate tumor cells while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic,” Pons said.

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