The FDA has placed a partial clinical hold on the pivotal clinical trial of a T-cell candidate from Adaptimmune Therapeutics ($ADAP), even though the study hasn’t started yet.
The trial is for Adaptimmune’s lead candidate NY-ESO, a specific peptide enhanced affinity receptor T-cell therapy targeting the NY-ESO cancer antigen, to treat myxoid-round cell liposarcoma (MRCLS).
This program is partnered with GlaxoSmithKline ($GSK) under a deal that was expanded in February. The pharma is slated to support the pivotal development of NY-ESO in another indication, synovial sarcoma, and to “explore development” in the indication in question: MRCLS.
The FDA has a couple of requests before the trial can commence. It wants more information on chemistry, manufacturing, and controls. In addition, it wants answers to other undisclosed questions about the trial.
The partial hold is not due to safety concerns, the company noted. And it said that the partial clinical hold doesn’t have any implications for any other Adaptimmune study.
The company said it will provide “a full response” to the FDA “shortly.” Still, Wall Street punishment came fast, sending the company’s shares down as much 13% in after-hours trading, but that decline later softened.
“Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.,” said Adaptimmune CEO James Noble in a statement.
He added, “We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly.”
The company reports its earnings on Aug. 8 and is expected to offer an update on the situation then.
Adaptimmune has deflated substantially since a wildly optimistic IPO last May. It raised $191 million in the IPO at $17 a share, which valued the company at $1.3 billion. Its shares now trade at below $9 each, giving it a market cap of about $620 million.
- here is the release
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