Magenta Searching for Options after Patient Death Halts Trial

2023-02-03
临床2期财报细胞疗法抗体药物偶联物临床1期
Courtesy of Getty Images Magenta Therapeutics has suspended the development of its clinical programs and initiated a strategic review of business alternatives after a patient's death halted a Phase I/II trial. The Massachusetts biotech paused a dose-escalation study of its lead asset, MGTA-117, in acute myeloid leukemia on Jan. 26th after a patient suffered respiratory failure and cardiac arrest. The death was deemed possibly related to the study drug. The trial hold was voluntary but by the recommendations of a safety Cohort Review Committee. Magenta reported the incident to the FDA as a Suspected Unexpected Serious Adverse Reaction. As of Sept. 30th, 2022, Magenta still had cash, cash equivalents and marketable securities amounting to $128.3 million. The company revealed in its third-quarter financial results, posted November 2022. At the time, Magenta expected its cash runway to extend through the middle of 2024. As part of its business review, the company will assess the feasibility of an acquisition, merger, business combination or other similar transactions. Though Magenta made no assurances that the review would lead to an attractive business option, the company’s shares rose 47% post-market trading Thursday. Suspended Stem Cell Programs Magenta's pipeline is focused on stem cell transplantation. The company was developing novel antibody-drug conjugates to enable either mobilization and collection, wherein stem cells are extracted from a patient’s or donor’s bone marrow, or conditioning, which involves the removal of stem cells from the recipient’s bone marrow. While ADCs have long been known to be effective against specific cancers, Magenta has pioneered its use in stem cell transplantation. MGTA-117 was tested as a conditioning agent. The candidate targeted the CD117 receptor and was designed to selectively deplete cells bearing this protein, thereby reducing or eliminating the need for chemotherapy. CD117 is a cell surface-bound protein enriched in hematopoietic stem cells and leukemia cells, making it a good conditioning target for many blood disorders. Magenta was also developing a second investigational conditioning agent, a CD45-targeted ADCCD45-targeted ADC. This candidate was in preclinical studies and had recently completed dose-ranging toxicology assessments with no unexpected findings. MGTA-145, an agonist of the CXCR2 protein, was designed to be used with plerixafor, a CXCR4 antagonist, to target complementary pathways to improve the process of stem cells being released into the bloodstream. The candidate was in two Phase II trials.
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