With its autologous CAR-T therapy, CDH17, results from the first six patients treated show stable disease in three patients. The update includes stable disease in Patient 6 with NeuroEndocrine Tumours (NETs) at Day 28, with shrinkage in five of the six measurable lesions, ranging from 6% to 37%. Of interest is that this patient experienced Grade 3 cytokine release syndrome, which, whilst a side effect, is an indicator of therapeutic action.
Data from Patients 7 and 8 at Day 28, who have colorectal cancer, is expected to be released shortly. The company will then progress to treating Patients 9 and 10, however the dose has yet to be selected. Patients 1–4 were treated with 50 million cells, and Patients 5–8 have been treated with 150 million cells. For Patients 9 and 10, the company has the option to increase the dose to 450 million cells, however it may also continue with the 150 million cell dose if tumour shrinkage continues to be observed (more likely given the Grade 3 CRS observed at this dose). Cells for Patients 9 and 10 (who have NETs) have already been manufactured.
Other important data emerging from this study is that the cells infused into the patients have shown to remain in the body for at least 200 days in one patient, with more data on cell longevity in patients to be provided when available.
CORE-NK Study Progress
In the company’s Phase Ib study using its CORE-NK immunotherapy in patients with AML, a response rate of 57% has been achieved (4/7 patients). This is an allogeneic therapy, whereby cells derived from one healthy donor can be used to treat as many as 200 patients. When the therapy was used in patients who had failed other therapies, only one complete response from six patients was achieved. However, when used as a frontline therapy, in combination with standard of care (azacitidine and venetoclax), three complete responses were achieved with one partial response.
This compares with an expected response rate from standard-of-care treatment of between 35% to over 50%, according to Dr. Jason Litten, the company’s CMO. Prolonged survival will be a key measure here, according to Dr. Litten, where patient survival can often be expected to be just weeks.
This study is being run by the M.D. Anderson Cancer Center. It is seeking to find out whether Natural Killer cells from a healthy person can be used to help control AML. NK cells are the body’s cancer and infection-fighting immune cells. The study will enrol up to 32 patients. The technology was developed at Case Western Reserve University and in-licensed by Chimeric Therapeutics in November 2022.
Bioshares recommendation: Speculative Buy Class B.
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