Category Archives: BCMA

Abecma Revenue Decreases Significantly; bbT4015 IND on Track for YE 2023; JW Tx to Initiate JWTCR001’s IIT by YE 2023; 2seventy Bio’s Q3 2023 Earnings Call

On Tuesday, November 14, 2seventy bio held its Q3 2023 earnings call (press release / webcast) acknowledging Abecma’s (BMS / 2seventy’s BCMA CAR-T) decline in US sales while confirming milestones for its preclinical cell therapy programs in solid tumors. Below, Celltelligence provides insights on the causes behind Abecma’s revenue decrease while discussing the company’s preclinical solid tumor pipeline.

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GC012F’s US Trial in MM Initiates Dosing; GC012F IND in SLE on Track for 2023; Gracell Initiates GC506 Clinical Development in Solid Tumors and Deprioritizes GC007g in B-ALL; Gracell’s Q3 2023 Earnings Call Summary

On Monday, November 13, Gracell held its Q3 2023 earnings call (press release) highlighting the initiation of dosing in the Ph1b/2 trial evaluating GC012F (BCMA x CD19 FasTCAR-T) for ≥4L MM in the US, while confirming that the IND submissions for the evaluation of GC012F in refractory SLE (rSLE) in the US and China remain on track for 2023. Additionally, the company disclosed the initiation of GC506 (CLDN18.2 SMART CAR-T) clinical development in solid tumors and the discontinuation of GC007g (allogeneic CD19 CAR-T) in B-ALL. Below, Celltelligence provides insights on GC012F potential in MM and rSLE while discussing possible causes of GC007g discontinuation and the initiation of the clinical evaluation of a CLL-1 x CD38 dual CAR-T in AML.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Roche Collaboration Milestones and Payments Accelerated; P-MUC1C-ALLO1’s Clinical Update Postponed to H1 2024; Poseida’s Q3 2023 Earnings Summary

On Thursday, November 9, Poseida released its Q3 2023 financial results and business updates (press release) highlighting the acceleration of certain milestone payments from the collaboration with Roche, based on P-BCMA-ALLO1 (allogeneic BCMA CAR-T) and P-CD19CD20-ALLO1 (allogeneic CD19 x CD20 CAR-T) programs progress. Additionally, the company noted the delay of the clinical update from the Ph1 trial evaluating P-MUC1C-ALLO1 (allogeneic MUC1-C CAR-T) in advanced or metastatic solid tumors, now expected in H1 2024. Below, Celltelligence provides insights on the potential implications of Roche’s accelerated payments in the development of P-BCMA-ALLO1 and P-CD19CD20-ALLO1 programs while discussing P-MUC1C-ALLO1’s previous results.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Abecma T2V Receives a Second RSI; When Could Abecma and Carvykti Receive a Positive CHMP Opinion? November CHMP Highlights

On Friday, November 10, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights, implying that it has received a second Request for Supplementary Information (RSI) for its approval in ≥3L MM. Moreover, recall that the Carvykti (JNJ’s / Legend’s BCMA CAR-T) T2V in ≥2L MM was not included on Monday’s CHMP Agenda. Below, Celltelligence provides insights on the November CHMP meeting with updated EU timelines for both cell therapies.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gilead’s Cell Therapy Revenue Continues to Grow; Promising Results from CART-ddBCMA Expected at ASH 2023; Gilead’s Q3 2023 Earnings Call Summary

On Tuesday, November 7, Gilead held its Q3 2023 earnings call (press release / presentation) highlighting increased sales for its cell therapy franchise. Additionally, the company underlined the presentation of a promising clinical update from CART-ddBCMA’s (KITE-772; BCMA CAR-T) Ph1 trial in ≥4L MM, co-developed with Arcellx, at ASH 2023. Below, Celltelligence provides insights on the barriers limiting Yescarta uptake in 2L LBCL in the US, while discussing the potential expansion of Gilead’s cell therapies outside of oncology.  

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Cellectis to Present Updated Clinical Data at ASH 2023; Caribou Still Plans to Share FDA Feedback on CB-010’s Pivotal Trial in 2L LBCL by YE 2023; Cellectis and Caribou Q3 2023 Earnings Summary

On Tuesday, November 7, Cellectis held its Q3 2023 earnings call (press release) highlighting new clinical data presentations from its pipeline programs at ASH 2023. On the same day, Caribou released its Q3 2023 financial results (press release) noting still plans to share the FDA feedback on CB-010’s (allogeneic CD19 CAR-T; PD-1 KO + TCR KO) potential pivotal trial in 2L LBCL by YE 2023 while sharing updated milestones for its other allogeneic cell therapy assets. Below, Celltelligence provides insights on the potential strategies of Cellectis and Caribou for the development of their cell therapy programs, while commenting on their recently closed partnerships with larger companies.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Could Abecma Receive a CHMP Positive Opinion this Week?; November’s CHMP Agenda

On Monday, November 6, the CHMP agenda for November was released. Of note, Abecma (BMS / 2seventy bio’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while Carvykti’s (JNJ / Legend’s BCMA CAR-T) Type II Variation for ≥2L MM was absent from the agenda.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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An ARI-0003 Trial to Be Initiated by Hospital Clinic; Mustang’s MB-109 Receives IND Clearance from the FDA

On Tuesday, October 24, a new early Ph1 CARTD-BG-1 trial evaluating ARI-0003 (BCMA x CD19 CAR-T), an academic CAR-T developed by the Hospital Clinic of Barcelona, Spain, in r/r B-cell aggressive lymphoma was posted on CT.gov. Moreover, on Thursday, October 26, Mustang Bio announced FDA acceptance of the IND application to evaluate MB-109 [MB‐101 (IL13Rα2 CAR-T) + MB-108 (HSV1 oncolytic virus)] in recurrent glioblastoma (GBM) and high-grade astrocytoma (press release). Below, Celltelligence provides insights on both cell therapies, discussing their potential advantages.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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BMS’s Cell Therapy Franchise Sales Decrease; KarMMa-9 Initiated; The FDA Clears BMS-986353’s IND in MS; First Patients in SLE Trial Dosed; BMS’s Q3 2023 Earnings Call Summary

On Thursday, October 26, BMS held its Q3 2023 earnings call (press release / presentation) disclosing a significant revenue decrease for Abecma (BCMA CAR-T) and a decline in Breyanzi (CD19 CAR-T) sales. Additionally, BMS confirmed the dosing of the first patient in the Ph1 trial evaluating BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in severe refractory systemic lupus erythematosus (SLE), while announcing IND clearance from the FDA to start a trial in multiple sclerosis (MS). Below, Celltelligence provides insights on the potential causes behind the Abecma and Breyanzi sales drops while discussing the initiation of the Ph3 KarMMa-9 trial in NDMM and BMS’s fast progress in the autoimmune disease space.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Carvykti’s Revenue Continues to Increase; CARTITUDE-6 Starts Recruitment; JNJ’s Q3 2023 Earnings Call Summary

On Tuesday, October 17, JNJ held its Q3 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth and reiterated the measures implemented to raise its manufacturing capacity. Moreover, on October 13, the status of the Ph3 CARTITUDE-6 trial was updated on CT.gov to report recruitment initiation. Below, Celltelligence provides insights on the increase in Carvykti sales and evaluates the potential of its revenue to further grow in the next quarters while discussing the initiation of the CARTITUDE-6 trial.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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