2seventy Bio suspends pediatric blood cancer trial after patient death, stock plummets


2seventy Bio Inc (NASDAQ: TSVT) announces that the Phase 1 trial of SC-DARIC33’s PLAT-08 study in acute myeloid leukemia (AML) has been suspended by its partner and regulatory sponsor of the study, Seattle Children’s announced that it was

This moratorium was introduced as part of a clinical study protocol termination rule following a recent Grade 5 (fatal) serious adverse event (SAE), which was subsequently approved by the U.S. Food and Drug Administration (FDA). The required notice has been given.

The underlying cause of this SAE and a potential relationship with the investigational drug are currently under investigation.

An SAE occurred in the first patient treated at the second dose level in the phase 1 trial.

Last month, 2seventy Bio presented the latest results of its ongoing Phase 1 PLAT-08 trial at the American Society for Gene and Cell Therapy (ASGCT) Annual Meeting.

Preliminary correlation analysis results from the PLAT-08 study demonstrate in vivo proliferation and activation of SC-DARIC33 T cells regulated by rapamycin and concomitant anti-CD33 activity.

The combination of controlled IL-15 production and rapamycin-controlled DARIC33 activation resulted in enhanced anti-acute myeloid leukemia (AML) efficacy.

Price action: TSVT shares were down 11.90% to $10.40 when last checked on Wednesday.

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This article originally appeared as 2seventy Bio paused pediatric blood cancer trials after patient death, stock price plummeted Benzinga.com


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