Solu Therapeutics’ CMML treatment put on FDA fast track
Small molecule takes targeted approach to treat aggressive cancer
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The U.S. Food and Drug Administration (FDA) has granted fast-track designation to STX-0712, an experimental therapy Solu Therapeutics is developing to treat chronic myelomonocytic leukemia (CMML), a rare and aggressive type of blood cancer.
The FDA gives this designation to investigational medicines designed to address unmet needs in the medical management of serious and life-threatening diseases. The goal is to accelerate the development and review of potentially important new therapies.
“Fast Track designation for STX-0712 reinforces the significant need for new treatment options for people living with CMML,” Philip Vickers, president and CEO of Solu Therapeutics, said in a company press release.
CMML is characterized by the abnormal, uncontrolled growth of a specific type of immune cell, the monocyte. Abnormal monocytes crowd out other healthy blood and immune cells, leading to complications such as anemia and an increased risk of infection. In some patients, CMML can progress to form a more aggressive form of blood cancer, acute myeloid leukemia (AML).
Depleting malignant cells
STX-0712 consists of a small molecule that targets CCR2, a protein expressed on the surface of cancerous monocytes. The CCR2-targeting small molecule is attached to a cell-killing antibody. The idea is that the small molecule will deliver the antibody to CCR2-expressing cancer cells, and the antibody will then kill those cells.
“By directly depleting CCR2-positive malignant monocytes and bone marrow [cells] that drive disease in CMML, STX-0712 has the potential to offer a highly specific and targeted approach,” Vickers said.
Solu is developing the therapy for CMML that is refractory or relapsed, meaning the cancer has failed to respond or has come back following prior treatments. The company is also exploring STX-0712 as a potential treatment for hard-to-treat AML and other blood cancer types.
“We look forward to continuing to work closely with the FDA as we advance through clinical development and work to bring this potential therapy to patients as quickly as possible,” Vickers said.
Dosing began last year in a Phase 1 clinical trial (NCT06950034) evaluating STX-0712 in people with CMML or AML who have no further treatment options. All participants in the trial will receive STX-0712 by infusion into the bloodstream every three weeks at various doses, with the main goal of assessing the therapy’s safety and identifying an optimal dose for future testing. Recruitment is ongoing at a half dozen sites in the U.S.
