Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, has received notification from the Food and Drugs Administration (“FDA”) that the proposed pre-Investigational New Drug (“pre-IND”) meeting relating to the Company’s lead product candidate Chimeric Antigen Receptor (“CAR”) T-cells (“HEMO-CAR-T”) is to be deferred until May 2022 as a result of a general FDA policy prioritizing work on COVID-19.
The deferment of the meeting is not causing any delay in the development of the product candidate. In the meantime, the process will be dealt with by written responses by the FDA to a submission which is now being refined. A pre-IND meeting will then be necessary only if the written responses leave any matters unresolved. In light of this written process now implemented by FDA, there is no anticipated impact from the deferment on the IND filing for HEMO-CAR-T.
As noted above, the process for pre-IND meetings has been amended by the FDA on a general basis, with the Agency stating as follows: “In response to the Coronavirus Disease 2019 (COVID-19) public health emergency, FDA’s Center for Biologics Evaluation and Research (CBER) has taken steps to prioritize work that advances the nation’s response during this national emergency.”
In the meantime, work on manufacturability, quality, safety and other key parts of the development HEMO-CAR-T continue in an encouraging manner.
In addition, positive progress continues in relation to the Company’s CDX bispecific antibody product candidate for the treatment of acute myeloid leukaemia, as well as its CBR platform product candidate, a novel cell-based platform technology for the treatment of emerging viral diseases and certain types of cancer. The Company will continue to notify shareholders as key stages with respect to all of its product candidates are reached.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: “The process toward our IND application remains on track and the change in the FDA’s process is not expected to affect the outcome of the IND application or timetable for clinical trials.”
About AML and CAR-T Therapy
AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of the new therapy for AML would have a major impact on treatment and survival rates for the disease.
CAR-T therapy is a treatment in which a patient’s own T-cells, a type of immune cell, are modified to recognize and kill the patient’s cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient’s cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.
Hemogenyx Pharmaceuticals plc
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder
Peter Redmond, Director
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