UK – Hemogenyx has received a green light from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical trial for its chimeric antigen receptor (CAR) T-therapy designed to combat acute myeloid leukaemia (AML) in the United States.  

This decision comes after a temporary setback in June 2023, when the FDA placed a clinical hold on Hemogenyx’s trial, known as HEMO-CAR-T, due to concerns regarding a manufacturing issue with the lentivirus used in CAR-T cell production. 

In response to the FDA’s request for additional information, Hemogenyx promptly developed a comprehensive plan supported by laboratory tests to address the concerns raised. 

 This plan was accepted by the FDA in August 2023, paving the way for the company to move forward.  

Finally, in January, Hemogenyx submitted a complete response to the FDA, leading to the uplifting of the clinical hold and allowing the Phase I trial to proceed. 

The news of the FDA’s clearance has had a significant impact on Hemogenyx’s stock price, with a remarkable 62% increase observed since the announcement, signaling strong investor confidence in the company’s potential. 

 Despite recent scrutiny surrounding CAR-T therapies, particularly regarding potential secondary malignancies, experts remain optimistic about the future of this innovative treatment approach. 

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 Recent regulatory actions by the FDA, including the addition of boxed warnings to certain CAR-T therapies, reflect ongoing efforts to ensure patient safety while advancing medical innovation. 

CAR-T cell therapy market to expand 

Despite these challenges, the CAR-T cell therapy market is expected to continue growing, with industry professionals emphasizing the benefits of these therapies outweighing associated risks.  

According to a report from GlobalData’s Pharma Intelligence Center, the global market value for both cell therapies and traditional AML treatments is projected to more than double by 2031, reaching $6.62 billion. 

AML, a type of cancer affecting the bone marrow and blood, presents significant challenges in treatment, with chemotherapy representing the current standard of care despite its limited efficacy and poor prognosis. 

 Hemogenyx’s HEMO-CAR-T therapy offers a promising alternative, utilizing genetically engineered T cells to target specific proteins on cancer cells, potentially offering patients a more effective and less toxic treatment option. 

Vladislav Sandler, CEO of Hemogenyx, said he was satisfied with the FDA’s decision and emphasized that the company was committed to advancing the clinical development of HEMO-CAR-T which will potentially offer patients a life-saving treatment. 

“We are extremely pleased with the FDA’s decision to lift the clinical hold. We now look forward to accelerating clinical development of HEMO-CAR-T and to offering patients a potentially life-saving treatment. “He said.  

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