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Janssen’s CAR-T gains PRIME status in Europe

EMA fast-track could help Janssen close gap

janssen

Janssen has been granted a valuable PRIME (Priority Medicines) designation from the European Medicines Agency for its CAR-T candidate for multiple myeloma, a fast-track status which could give it an advantage in the race to market.

Its investigational B-cell maturation antigen (BCMA) CAR-T therapy is named JNJ-68284528 (JNJ-4528), which the company acquired rights to when it signed a co-development deal with Chinese firm Legend Biotech in December 2017.

The EMA’s PRIME status offers enhanced interaction and early dialogue to help companies accelerate their development plans and speed up evaluation for cutting-edge therapies in areas of high unmet medical need.

“CAR-T therapy is an exciting therapeutic platform that harnesses the patient’s immune system to attack tumour cells,” said Sen Zhuang, VP, oncology clinical development, Janssen Research & Development.

“We continue to advance this novel BCMA targeted CAR-T therapy through clinical studies globally as we strive to bring it to the patients with multiple myeloma around the world.”

Janssen are in a crowded field of competitors all racing to bring BCMA-targeting therapies to market within the next few years. The PRIME status could help it close the gap on its rivals, some of whom are a few steps ahead of Janssen.

Bluebird Bio and Celgene and currently seen as the frontrunners with their late-stage CAR-T candidate bb21217, while Celgene has a similar challenger in development with Juno.

Amgen is also in the race with its bispecific T cell engager (BiTE) immunotherapy AMG 420, while  GSK has just unveiled promising data for its antibody drug conjugate.

JNJ-4528 is currently being investigated for myeloma patients who have received at least three prior regimens, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody, and have documented disease progression within 12 months of starting the most recent therapy, or are double refractory to an IMiD and PI.

The CAR-T therapy would complement Janssen's presence in the myeloma market, where rising star Darzalex is expanding fast into frontline use.

Article by
Andrew McConaghie

4th April 2019

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