Cell therapy CER-1236 put on FDA fast track as AML treatment
Phase 1 trial is testing different doses to assess treatment's safety
The U.S. Food and Drug Administration (FDA) has granted fast track designation to CER-1236, an experimental cell therapy that Cero Therapeutics is developing to treat acute myeloid leukemia (AML), a type of blood cancer.
FDA fast track status is designed to speed the development of treatments that have the potential to fill unmet needs in the care of serious diseases. The designation gives Cero access to perks such as more frequent communications with the FDA during the drug development process.
CER-1236 also has FDA orphan drug status, which offers incentives for companies to invest in investigational therapies designed to treat rare diseases.
“These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitted. Further, these designations help to decrease the potential time to market and provide additional benefits across the FDA process that are expected to prove both medically and financially valuable,” Chris Ehrlich, CEO of Cero, said in a company press release.
Engineering T-cells to kill cancer cells, trigger immune response
CER-1236 works by collecting T-cells, a type of immune cell that can kill cancer cells, from a patient and equipping them with a molecule called a chimeric engulfment receptor (CER), a molecular weapon that directs the T-cell to kill and eliminate the cancer cells. The cells are then infused back into the patient’s body.
This approach is similar to CAR T-cell therapy, an approved blood cancer treatment strategy that also works by taking a patient’s T-cells and equipping them with a receptor to target cancer cells. The key difference is that CER-1236 uses a CER, whereas CAR T-cells use a different type of receptor called a chimeric antigen receptor (CAR). The CAR triggers the T-cell to kill the cancer cell, but unlike the CER, it doesn’t also prompt the T-cell to engulf and flag the cancer cell to be cleared by the immune system. According to Cero, its approach is expected to trigger a more powerful anticancer immune response.
Cero is sponsoring a first-in-human Phase 1 clinical trial (NCT06834282) testing CER-1236 in adults with AML. All participants in the trial will receive CER-1236 treatment, in addition to intensive chemotherapy that aims to wipe out the existing immune system to make room for the therapeutic cells.
The first part of the study, which dosed its first participant earlier this year, is testing several different doses of the therapy, with the main goal of assessing safety. Based on results from the first part, one dose will be selected to test in more patients in the second part, which aims to determine how many patients respond to treatment. The trial is recruiting participants at sites in Colorado, Tennessee, and Texas.
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