We’re Back! Holiday Recap Ahead of JPM 2024 (Blast 1/2): Thoughts on AstraZeneca’s Acquisition of Gracell
Happy New Year! It’s great to be back in 2024 serving our growing audience!
Happy New Year! It’s great to be back in 2024 serving our growing audience!
On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment.
ASH 2023 Analysis 7: BMS / 2seventy and JNJ / Legend presented analyses from their BCMA CAR-Ts in early line MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:
ASH 2023 Analysis 6: Arcellx, Gracell, and Poseida presented updated clinical data about their cell therapies in multiple myeloma. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:
On Monday, December 11, the CHMP Agenda for December was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM, while Abecma (BMS / 2seventy bio’s BCMA CAR-T) Type II Variation for ≥3L MM was absent from the agenda.
ASH 2023 Analysis 1: BMS and Autolus presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:
On Monday, November 27, Autolus announced (press release) the submission of a BLA to the FDA for the use of obe-cel (CD19 CAR-T) in adult r/r B-ALL, supported by data from the Ph1/2 FELIX trial.
On Monday, November 20, BMS / 2seventy bio announced (press release) that the FDA Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the sBLA for Abecma (BCMA CAR-T) in triple-class exposed MM. Importantly, the companies disclosed the FDA will not meet the PDUFA date originally set for December 16, 2023. Below, Celltelligence provides insights on the possible reasons behind the FDA’s decision, while discussing potential timelines for the ODAC meeting and the new PDUFA date.
On Monday, November 20, Legend held its Q3 2023 earnings call (press release) highlighting that the Ph3 CARTITUDE-6 trial evaluating Carvykti (BCMA CAR-T) versus ASCT in NDMM will start recruitment soon in the US while noting that its new production plant in Ghent, Belgium will be ready for clinical trial manufacturing by YE 2023. Below, Celltelligence provides insights on JNJ / Legend strategies to increase Carvykti manufacturing capacity, while discussing a slowdown of Carvykti’s sales in Q4 2023 and the initiation of CARTITUDE-6 trial in the US.
On Wednesday, November 15, Arcellx and Gilead announced (press release) an expansion of their existing partnership, whereby Gilead includes lymphomas in the scope of the collaboration for CART-ddBCMA (BCMA CAR-T) and exercises its option to license ACLX-001 (universal ARC-T cell + BCMA-targeting SparX protein) in MM. Additionally, on Monday, November 13, Arcellx released its Q3 2023 business updates (press release) highlighting the presentation of promising clinical data from CART-ddBCMA’s Ph1 trial in ≥4L MM at ASH 2023. Below, Celltelligence provides insights on the potential of using a BCMA CAR-T in lymphomas, while discussing CART-ddBCMA’s excellent profile in MM and ACLX-001’s main characteristics and competitive advantages.