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Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

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. 

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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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Anito-cel Elicits Improved Responses Across HR Subgroups; Gracell’s GC012F Shows Best-In-Class Safety and Efficacy Profiles; Increased Lymphodepleting Dose Enhances P-BCMA-ALLO1’s Responses Significantly; ASH 2023 Analysis 6

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: 

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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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A New Pivotal Trial for Caribou’s CB-010 in ≥2L LBCL to Start in 2024; Is the FDA Changing Perspective on the Clinical Development of Allogeneic CAR-Ts in Earlier Lines?

On Tuesday, December 12, Caribou announced (press release) positive FDA feedback for the initiation of a Ph3 trial evaluating CB-010 (allogeneic CD19 CAR-T; PD-1 KO + TCR KO) in patients with ≥2L LBCL, set to start by YE 2024. Below, Celltelligence provides insights on the significance of the FDA’s decision, discussing the possible outcomes of CB-010 in ≥2L LBCL and the hurdles that Caribou could encounter along the clinical development of its lead asset.

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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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Obe-cel Demonstrates Promising Efficacy in Patients with Low Leukemia Burden; Pooled Analysis from ALLCAR19 and FELIX Trials Suggests Long Durability of Response; ASH 2023 Analysis 2

ASH 2023 Analysis 2: Autolus presented updated clinical data from its lead asset obe-cel (CD19 CAR-T). Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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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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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Content Leads & Contributors

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

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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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Content Leads & Contributors

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

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Content Leads & Contributors

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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Afami-cel BLA Submission on Track for YE 2023, Lete-cel IND Set to Transition from GSK by YE 2023; MSLN TRuC Programs Deprioritized; Adaptimmune to Advance PRAME Program to the Clinic in 2024; Adaptimmune’s Q3 2023 Earnings Call

On Wednesday, November 8, Adaptimmune held its Q3 2023 earnings call (press release / webcast), confirming that completion of the BLA submission for afami-cel (MAGE-A4 SPEAR-T) is still on track for Q4 2023 while highlighting that the transition of lete-cel (NY-ESO-1 TCR-T) IND from GSK is expected to be closed by YE 2023. Moreover, management anticipated updated milestones for its pipeline assets, including deprioritizing two clinical programs and the selection of a PRAME candidate for clinical development. Below, Celltelligence provides insights on afami-cel potential approval, while discussing Adaptimmune’s pipeline re-prioritization strategy.

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The Celltelligence Team

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Content Leads & Contributors

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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Content Leads & Contributors

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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