EMA approved CAR-T therapy Carvykti for treatment of multiple myeloma

CLINICAL AND REGULATORY

EMA approved Carvykti for treatment of patients with multiple myeloma

Approved in the US about four weeks ago, J&J and Legend’s new drug Carvykti will rival BMS and bluebird bio’s BCMA CAR-T Abecma, although Legend and Janssen say some long-term data suggest they may have an advantage. While in the EU the Commission still needs to sign off on Carvykti for full approval, the CAR-T is launching in the US at $465,000, which is higher than Abecma’s $419,500 price tag.

Legend announced it will terminate early-stage CAR T program

Legend Biotech said in an SEC filing that it has terminated a Phase 1 trial of its autologous CAR T therapy LB1901 due to a lack of clinical benefit demonstrated by a different product candidate expressing the same CAR protein. FDA placed a clinical hold on LB1901 in February, after the only patient dosed in the study had a low CD4+ T cell count in peripheral blood. The hold was lifted on May 25.

DEALS AND FINANCING

Cartography emerges from stealth to map cancer antigens

Cartography is expanding the world of tumor antigen targets for CAR T cells and other new modality therapies with a platform that can pick up on targets missed by conventional screening methods. San Francisco Bay Area-based Cartography Biosciences Inc. emerged from stealth on Tuesday with $57 million in total funding and cell therapy pioneer Carl June heading up its scientific advisory board. The funding includes $51 million in a series A round led by new investor 8VC. Finding tumor-selective targets, especially for CAR

T cells and other modalities that need to differentiate tumor cells from healthy tissue by targeting a cell surface antigen — has been one of the biggest development challenges for oncology drug developers. Most antigens are also expressed by healthy tissues, and antigens that are solely expressed by tumor cells, neoantigens, are almost always unique to an individual patient.

Legend rises after pricing of $350 million upsized financing

Shares of Legend Biotech rose after the CAR T company raised $350 million in a bumped up follow-on. The company, which was seeking to raise $250 million, sold 8.1 million ADSs at $43 per ADS, a 15% discount to the ADS’s close of $50.50, before the offering was announced. The deal comes a week after the company reported its preliminary sales of multiple myeloma CAR T therapy Carvykti ciltacabtagene autoleucel, which brought in $24 million in 2Q22.

Enkai raises RMB100M to further develop its NK cell technology

Shanghai Enkai Cell Technology completed a RMB100 million ($15 million) round, led by Huagai Capital with participation from Chinese Academy of Sciences Venture Capital, Gandao Fund, Chengyi Capital, Sirius Capital, and Qiao Jing Capital. Enkai will use the money to develop its NK cell-based pipeline. The company’s technical team is led by academic immunologist Tian Zhigang.

CAR NK cell company Jingda Biotechnology raises pre-A round

Beijing Jingda Biotechnology completed a pre-series A financing amounting to tens of millions of yuan round led by Jinke Junchuang and with participation from Deyuan Pharmaceutical, Zhiheng Ventures and other undisclosed investors. Jingda did not more precisely disclose the amount of money raised, but said it would be used to advance its first CAR NK cell  therapy into the clinic to treat hematological tumors and undertake preclinical research of assets targeting solid tumors.