No Cell Therapy-Related Updates in March’s CHMP Agenda
On Monday, March 18, the CHMP Agenda for March was released. Of note, no cell therapy-related updates were observed.
On Monday, March 18, the CHMP Agenda for March was released. Of note, no cell therapy-related updates were observed.
On Thursday, March 14, BMS announced (press release) that the FDA granted accelerated approval (AA) of Breyanzi (CD19 CAR-T) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) adult patients who have received at least 2 prior LoT including a BTK inhibitor and a BCL-2 inhibitor.
On Thursday, March 14, Autolus held its Q4 2023 earnings call (press release/ presentation) highlighting the recent submission of a Market Authorization Application (MAA) for obe-cel (CD19 CAR-T) in r/r ALL, while noting that its Nucleus manufacturing facility has successfully passed its first GMP inspection enabling the commercial product supply for obe-cel. Additionally, the Ph1 CARLYSLE confirmatory trial evaluating obe-cel in severe, refractory SLE, and the Ph1 MAGNETO trial studying AUTO6NG (GD2 CAR-T) in pediatric glioblastoma have been initiated.
On Monday, March 11, Caribou released its Q4 and FY 2023 results (press release) highlighting that an updated timeline for the initiation of CB-010’s (allogeneic CD19 CAR-T) pivotal Ph3 trial in ≥2L LBCL is expected in Q2 2024 while noting that the first patient has been dosed in the Ph1 AMpLify trial evaluating CB-012 (allogeneic CLL-1 CAR-T) in ≥4L MM. Of note, the company has paused the development of CB-020 (allogeneic ROR-1 CAR-iNK) as part of a regular portfolio prioritization process.
On Thursday, March 7, Poseida released its Q4 and FY 2023 business updates (press release) highlighting clinical results from its lead asset P-BCMA-ALLO1’s (allogeneic BCMA CAR-T) Ph1 trial in r/r MM and an initial readout from its P-MUC1C-ALLO1’s Ph1 trial in advanced or metastatic solid tumors will be presented at AACR 2024.
On Thursday, March 7, a new BMS-sponsored Ph2 trial (QUINTESSENTIAL) evaluating BMS-986393 (CC-95266; GPRC5D CAR-T) in quadruple-class exposed [including: an immune modulatory drug (IMiD), a proteasome inhibitor (PI), an anti-CD38 mAb, and an anti-BCMA therapy] ≥4L MM was observed on CT.gov.
On Wednesday, March 6, Adaptimmune held its Q4 2023 earnings call (press release / webcast) highlighting the company’s preparation for the potential launch of afami-cel (MAGE-A4 SPEAR-T) in Q3 2024 in the US. Below, Celltelligence provides insights on the launch preparation of afami-cel upon FDA approval, while commenting on the rest of the company’s pipeline updates.
On Tuesday, March 5, 2seventy bio held its Q4 and FY 2023 earnings call (press release / webcast) acknowledging the decline in Abecma (BMS / 2seventy bio’s BCMA CAR-T) sales in the US. Below, Celltelligence provides insights on the reasons behind the Abecma revenue decrease, while commenting on the future opportunities for the BCMA CAR-T upon its potential approval in ≥3L MM.
On Thursday, February 28, Arcellx released its Q4 and FY 2023 results (press release) highlighting the recent expansion of the partnership agreement with Gilead (Kite). Moreover, as disclosed in a SEC filing, the companies are planning to include patients who have received prior BCMA-targeted treatments to support anito-cel’s label expansion into earlier MM lines while initiating additional clinical trials ex-US.
On Friday, February 23, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM.