J&J Repurposing US Site to Support CAR-T Manufacturing

Johnson & Johnson is renovating a facility in the US to make anti-cancer CAR-T candidate LCAR-B38M licensed from Legend Biotech last year.

In December 2017, J&J subsidiary Janssen Biotech, Inc., entered into the chimeric antigen receptor (CAR) T-cell space through a US$350 million (€304 million) collaboration and licensing deal with Chinese firm Legend Biotech.

Legend’s oncology candidate, LCAR-B38M, targets the B-cell maturation antigen (BCMA) and is under review in China. At the Goldman Sachs Annual Global Healthcare Conference earlier this month, J&J said plans to bring the CAR-T therapy to the US are proceeding well.

“We just closed [the Legend] deal at the end of last year, have already received IND, manufacturing in the US. and have initiated our Phase I/II trial looking at the dose filing in the US population,” said Tom Cavanaugh, president of Janssen Oncology.

Manufacturing Plans

Cavanaugh’s comments implied Janssen has moved forward with manufacturing plans, less than two months after J&J CEO Dominic Caruso told investors of the firm’s desire to invest in new technologies and capabilities, including CAR-T.

Therefore, BioProcess Insider contacted Janssen for more information, and according to spokesperson Caroline Pavis, the firm is investing in manufacturing capabilities for LCAR-B38M.

“For the US market we are renovating existing facilities in the US for clinical supply and commercial processing and production.”

When pushed for details, she said J&J is not disclosing the information but in terms of its cell and gene therapy network will “continue to evaluate opportunities that have potential to advance science and transform patients’ lives.”

According to its 2017 annual report, J&J has 125 manufacturing sites across all its divisions, with 40 located in the US.

I-O Legend

Janssen Biotech, Inc., entered the collaboration and licensing agreement with Legend Biotech after the firm presented impressive data at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. With biopharma peers Novartis and Gilead already reaching CAR-T therapy success, J&J was deemed late to the space.

However, according to Cavanaugh, Legend’s CAR-T products are “somewhat differentiated than the other CAR-Ts that you have on the marketplace, specifically in the way which it binds to the epitope, many of the ones that you have that have also been presented have one single strand bond to the epitope with the structure of that CAR-T.

“Our Legend compounds looks at two strands of epitopes to bind the two distinct parts or two distinct epitopes of BCMA antigen.”

Editor’s Note, 7/5/2018: This article has be updated. The previous version said that Janssen Pharmaceuticals, not it’s subsidiary, Janssen Biotech, Inc. was involved and that they had “acquired” Legend Biotech rather than “entered into a worldwide collaboration and licensing agreement”  with them.