Cargo Therapeutics Halts Lead CAR-T Program and Cuts Workforce by 50% Amid Efficacy and Safety Setbacks

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Recently, Cargo Therapeutics is alleviating its burden by laying off 50% of its staff and abandoning its lead candidate drug after experiencing weaker durability and severe side effects. The drug, known as firicabtagene autoleucel or firi-cel, is an autologous CD22 CAR-T cell therapy that has been undergoing Phase 2 trials in patients with large B-cell lymphoma whose disease has relapsed or who have not responded to CD19 CAR T therapy.

Just three weeks ago, the outlook for firi-cel seemed positive, with Cargo Therapeutics reporting that 71 patients had been dosed in the trial.This biotech company is "expected" to report a mid-term analysis of the data in the first half of this year, referring to it as a "potentially pivotal" study.

This biotech company announced yesterday that it had conducted an "interim analysis" of the trial "prompted by recent safety events."Although a review of data from 51 patients showed an overall response (OR) rate of 77% and a complete response (CR) rate of 43%, the durability of the CR rate at three months was only 18%.

More importantly, 18% of patients developed immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), a toxicity associated with CAR T-cell therapy, reaching grade 3 or higher.These included Grade 4 and Grade 5 serious adverse events, with Grade 5 indicating death, although Cargo did not specify how many patients experienced this outcome.

It is reported that Cargo Therapeutics, Inc. went public at a valuation of $200 million in 2022, and conducted an IPO worth $281 million the following year.Following the news about Firi-cel, the company's stock price plummeted, with its market value dropping 75% to $3.31 in pre-market trading on Thursday, compared to Wednesday’s closing price of $13.19.

Cargo Therapeutics' Stock Price Plummets

After determining that the data "does not support a competitive benefit-risk profile for patients," Cargo Therapeutics decided to cancel the firi-cel program.The company's new focus will be on incorporating its trispecific CAR-T CRG-023 into a Phase 1 dose-escalation trial.

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With $368.1 million on hand entering the new year, the biotech firm said it will halve its workforce to extend its cash runway into the middle of 2028 while continuing to "evaluate strategic options."

"We are disappointed by these unexpected results from the Phase 2 study," said Gina Chapman, CEO of Cargo Therapeutics, in the press release."The durability of complete remission is an important clinical goal for patients with R/R LBCL undergoing CD19 CAR T-cell therapy."The incidence and severity of IEC-HS have been higher than expected, and the data generated to date have not met our expectations for providing a competitive benefit-risk profile for patients in the context of available treatment options.

William Blair analysts said they were disappointed that firi-cel failed to deliver on the promise shown in the Phase 1 trial, where the median PFS and OS for the 20 patients who achieved CR were not reached.

Analysts wrote in a report on January 30:"Moreover, we recognize that this is a patient population with severe illness who have previously received CAR-T therapy. Therefore, their CAR-T products may contain a higher proportion of terminal effector memory cells or immunosuppressive T regulatory cells, which could be the reason for the lack of durability.""We are also surprised by the high rate of IEC-HS, as this was previously only observed in products manufactured with higher doses or different potency parameters."”

References:

https://www.fiercebiotech.com/biotech/cargo-offloads-car-t-along-half-its-workforce-wake-efficacy-toxic-side-effects

https://stockanalysis.com/

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