Bluebird Bio reports positive early safety data from Ph I CAR-T trial
Interim data presented at a conference in Munich, Germany suggest bb2121 has a positive therapeutic impact and is safe.
David Davidson, Bluebird chief medical officer, said: “We are pleased that these early data from our ongoing Phase I study of bb2121 demonstrate objective anti-tumor responses in heavily pre-treated patients with multiple myeloma.
He added that: “We are also encouraged by the safety profile to date, particularly the lack of severe cytokine release syndrome or neurotoxicity.”
CAR-T turmoil
The report of a positive Ph I safety profile comes at the end of a rough few weeks for the chimeric antigen receptor (CAR) T-cell sector.
The death of two patients in a Phase II trial of Juno Therapeutics’ CAR-T candidate JCAR-015 last week saw the firm’s share price plummet and prompted some to question the safety of the entire therapeutic class.
Juno has yet to determine the cause of the tragedy, although its previous suggestion chemotherapy that patients received in addition to JCAR-015 was to blame looks unlikely to be accurate.
Adverse events were observed during a Phase I study of JCAR-015.
Last May, Juno reported that Severe cytokine release syndrome (CRS) was observed in nine of the 39 patients given the therapy. Several patients also showed signs of neurotoxicity.
Timing
At first glance the timing of Bluebird's announcement appears, at least in part, to be a response to the recent questions raised about CAR-T therapies.
The presentation at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany was added to the programme at the last minute.
However, Bluebird Bio head of investor relations Manisha Pai rejected the suggestion, telling us “the decision to present our data at the symposium predated the news from Juno, and thus the two are not related at all.”
She added that: “It’s difficult to pinpoint exactly what led to the toxicity that caused the tragic deaths in the Juno study – there are many differences among their programs and the other CAR T programs in the field."
