Category Archives: Autologous

Could Carvykti Receive a Positive Opinion this Week? The Obe-cel Accelerate Assessment to Be Discussed for Adoption; December’s CHMP Agenda

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.

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BMS-986393 Continues Showing Impressive ORR in ≥4L MM but Durability Fails to Impress; Initial Promising Results from AUTO8 in r/r MM; ASH 2023 Analysis 1

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:

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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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Adaptimmune Completes Afami-cel Rolling BLA Submission in Advanced SS

On Wednesday, December 6, Adaptimmune announced (press release) the completion of the afami-cel (MAGE-A4 SPEAR T-cell) rolling BLA submission for the treatment of advanced synovial sarcoma (SS). Of note, the submission is supported by results from Cohort 1 of the pivotal Ph2 SPEARHEAD-1 trial. Below, Celltelligence provides insights on afami-cel’s results in r/r SS, while discussing the potential path of lete-cel (NY-ESO-1 TCR-T) in the same indication.

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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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Novartis to Rapidly Advance YTB323 in Autoimmune Diseases; Cell Therapy Evaluation in MS Could Be Initiated Soon; Novartis’s R&D Day Summary

On Tuesday, November 28, Novartis held its R&D Day 2023 (press release / presentation) highlighting preparations for a Ph2b/3 study evaluating YTB323 (CD19 T-Charge CAR-T) in srSLE/LN while noting the data of 3 sentinel patients from the Ph1/2 trial in srSLE presented at ACR 2023. Additionally, the company disclosed it is preparing trials for other B-cell-driven indications and suggested it could evaluate the potential of cell therapies in MS. Below, Celltelligence provides insights on Novartis’s progress in autoimmune diseases while discussing the consequences that the FDA’s investigation into secondary T-cell malignancies after CAR-T infusion may have 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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Autolus Submits Obe-cel BLA in R/R B-ALL; GC012F Receives IND Clearance in rSLE

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.

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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 sBLA to Face FDA AdCom; PDUFA Date Delayed; Could Carvykti Be Approved Before Abecma in Earlier Lines of MM?

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.

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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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CARTITUDE-6 to Start Recruiting Soon in the US; Legend’s Facility in Belgium Set to Start Clinical Trial Manufacturing; Legend’s Q3 2023 Earnings Call Summary

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.

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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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Thoughts on the Expansion of Arcellx and Gilead Partnership; Gilead to Expand Scope of CART-ddBCMA to Lymphomas and Exercise Option to ACLX-001

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.

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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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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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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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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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