The Hemogenyx Pharmaceuticals PLC (LON: HEMO) share price edged 7.92% higher after revealing that it had submitted an Investigational New Drug (IND) application seeking the FDA’s approval to start a Phase I clinical trial of its lead drug candidate Chimeric Antigen Receptor (CAR) T-cells (HEMO-CAR-T) for treating acute myeloid leukaemia (AML).
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Investors cheered the development, bringing Hemogenyx closer to having a commercial drug once HEMO-CAR-T enters clinical trials. The IND application follows the company’s successful work on safety, quality and manufacturing, among other critical aspects of developing HEMO-CAR-T.
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Hemogenyx plans to kickstart the Phase I clinical trial of HEMO-CAR-T once the FDA approves its IND application clearing it to proceed with the trial. Acute myeloid leukaemia (AML) is the most commission type of acute leukaemia in adults and has a poor survival rate of less than 30% in adults over five years.
AML is currently treated using chemotherapy rather than the potentially more benign and effective therapy developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML would significantly impact the disease’s treatment and survival rates.
CAR-T therapy is a treatment that uses the patient’s T-cells, a type of immune cell, which is modified to recognise and kill the patient’s cancer cells. The procedure requires isolating T-cells from the patient and modifying the isolated T-cells in a laboratory using the CAR gene construct.
The CAR gene construct allows the cells to recognise the patient’s cancer, amplifying (growing into more significant numbers) the newly modified cells and reintroducing the cells back into the patient.
Investors cheered the progress made by Hemogenyx in advancing its CAR-T technology to the point at which it is ready to conduct a clinical trial and has made an IND application to the FDA. However, most investors will wait to see if the FDA approves the IND application.
Dr Vladislav Sandler, Hemogenyx Pharma’s CEO & Co-Founder, commented: “We are pleased to have reached this milestone with HEMO-CAR-T. We are committed to advancing therapies for blood diseases, and our work to address AML, which currently has poor survival rates, is an essential part of that commitment.”
*This is not investment advice.
Hemogenyx share price.
The Hemogenyx share price edged 7.92% higher to trade at 2.18p, from Friday’s closing price of 2.02p.
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