Allogene expects manufacturing specifications to be a focus of IND reviews as it looks to bring an off-the-shelf CAR-T therapy for multiple myeloma through the clinic.

Chimeric antigen receptor (CAR) T-cell therapies have been described as “one of the newest, emerging weapons in the fight” against multiple myeloma, a cancer affecting around 300,000 Americans every year.

Some of the candidates in the clinic for multiple myeloma include Bluebird and Celgene’s BB21217, Celgene’s JCARH125 and Janssen/Legend Biotech’s LCAR-B38M, but these – like the two commercially available CAR-T therapies Kymriah and Yescarta – are all autologous therapies.

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However, Allogene Therapeutics, founded last year by the former directors of Kite Pharma, is attempting to gain the upper hand in the field by developing an allogeneic – or off-the-shelf – CAR-T therapy, ALLO-715.

“Multiple myeloma is a competitive field, but we believe an off-the-shelf CAR T therapy could be game changing for patients, and we are working hard to be among the first to introduce such a candidate into the clinic,” CEO David Chang said on the firm’s Q1 financial call last week.

“As is typical with any new therapeutic modality, industry pioneers are encountering novel challenges including the evolving FDA specifications related to product characterization for allogeneic cell therapy. We expect manufacturing specifications will be a focus of IND reviews.”

ALLO-501

The firm has recently submitted an Investigational New Drug (IND) for ALLO-715 and expects to initiate the Phase I study before the end of the year.

Allogene hopes to leverage lessons learned from its IND submission for Non-Hodgkin’s lymphoma candidate ALLO-501 to be proactive in bringing ALLO-715 into trials.

“Our baseline assumption is that the IND for ALLO-715 will be very similar to what we have done for ALLO-501. And in fact, in the experience that we have gathered through ALLO-501 is really helping us as we prepared and submitted the IND for the ALLO-715,” said Chang.

ALLO-501 was accepted in January and Allogene will be working with the lead investigators involved in the Yescarta pivotal trial.

“Their extensive experience in CAR T therapy will be invaluable as we advance ALLO-501 through Phase I development and set the stage for our potential pivotal Phase II trial. With multiple sites fully activated, we are very pleased with the progress of this program.”