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Trailing the Big Pharma players, a lesser known BCMA CAR-T candidate comes into the spotlight

2021.06.09 | IASO,IASO Bio,IASO Biotherapeutics,IASO Biopharma,CT103A, CAR-T, cell therapy,dual-targeted CAR-T

Bristol Myers Squibb and bluebird cleared the first BCMA CAR-T therapy for multiple myeloma patients back in March, and J&J and their partners at Legend Biotech aren’t far behind. Now, a lesser known candidate developed in China is coming into the spotlight at EHA.


IBI326, a BCMA CAR-T therapy developed by Innovent Biologics and IASO Biotherapeutics, had a 97.1% overall response rate in 35 patients with relapsed or refractory multiple myeloma, according to updated Phase I data the companies are taking to EHA. IASO CEO Maxwell Wang says it’s the only oral presentation on a Chinese BCMA CAR-T at this year’s conference.


Multiple myeloma is a blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. While some patients achieve remission, most relapse, and 29% die within one year of diagnosis.


In the 35 patients treated with one of three doses of IBI326, 29 (or 82.9%) achieved a very good partial response or greater, and 20 (57.1%) saw a complete response or stringent complete response. Of 34 patients evaluable for minimal residual disease (MRD), all achieved MRD negativity, according to the companies.


The analysis includes eight patients with extramedullary multiple myeloma (EMM), and 10 patients who had previously received a murine BCMA CAR-T treatment, all of whom saw a response, Innovent and IASO reported. Among the 10 patients who had taken a murine BCMA CAR-T treatment, eight achieved a very good partial response or better, one saw a partial response, and another reached stable disease.


These numbers are slightly down from the data Innovent and IASO brought to ASH back in 2019, which showed that 70.6% of 17 evaluable patients treated with IBI326 saw a complete response or stringent complete response, and 88.2% achieved a very good partial response or better.


As with previous CAR-Ts, there’s a risk of cytokine release syndrome, an acute systemic inflammatory condition characterized by fever and multiple organ dysfunction. Five of the 35 patients from the recent analysis experienced CRS of Grade 3 or above. The median time to onset was 4 days, and all cases could be controlled with tocilizumab and/or steroids, Innovent and IASO said.


The candidate is currently in a pivotal Phase II trial, and in February it was granted breakthrough designation from China’s regulatory authority, the National Medical Products Administration (NMPA).


 Ahead of this year’s ASCO, J&J and Legend Biotech unveiled updated data for their own BCMA-CAR-T cilta-cel in multiple myeloma. In a Phase II trial, cilta-cel showed a 95% overall response as of a February cutoff, with a 75% stringent complete response. The data are part of the package J&J is submitting in rolling applications for approvals in Europe and the US.


While experts from the University College London Cancer Institute noted in Blood that outcomes from J&J’s CARTITUDE-1 trial of cilta-cel were better, they said Innovent and IASO’s candidate is noteworthy for its duration of CAR persistence.


“One feature that casts doubt for any real potential for durable responses in MM is that MM CAR T cells do not persist in patients,” they wrote.


Back in 2019, Innovent and IASO reported that IBI326’s median CAR transgene persistence was 307.5 days. And on Monday, they said three patients showed persistence for over two years, the first of whom achieved a stringent complete response.