来源: Pharmaceutical Technology
The FDA placed a clinical hold on the trial for HEMO-CAR-T in June, requesting additional information from Hemogenyx. Credit: JHVEPhoto via Shutterstock. 来源: Pharmaceutical Technology
In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. Despite this, the CAR-T cell therapy market is still expected to grow, with many professionals arguing that the benefits outweigh the risks associated with the therapies. According to a report on GlobalData’s Pharma Intelligence Center, the total market value for both cell therapies and established/traditional AMLAML therapies, is expected to increase from $3.1bn in 2021 to $6.62bn in 2031 globally. See Also:Why patient centricity is the answer to the clinical trial enrolment gap
来源: Pharmaceutical Technology
Pfizer and Saama expand deal to expedite clinical research 来源: Pharmaceutical Technology
AML, a cancer that affects the bone marrow and blood, is characterised by the rapid growth of abnormal white blood cells, which interfere with the production of normal blood cells. The current standard of care for AML is chemotherapy, with the cancer generally having a bad prognosis. HEMO-CAR-T comprises T cells genetically engineered to express chimeric antigen receptors, targeting cells expressing Fms-like receptor tyrosine kinase 3 (FLT3). T cells are extracted from the patient, modified to target specific proteins on cancer cells, and then infused back into the patients’ bloodstream. In the announcement accompanying the announcement, CEO of Hemogenyx Vladislav Sandler said: “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.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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Free WhitepaperCell and gene therapies: Pipe dream to pipeline
The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. 来源: Pharmaceutical Technology
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