Category Archives: Uncategorized

Breyanzi Demonstrates Long Duration of Response in 2L Transplant Ineligible LBCL and Consistent RW Results Regardless of Comorbidities in R/R LBCL; Prior Bridging Therapy Does Not Impact Yescarta Efficacy or Safety in R/R LBCL; ASH 2023 Analysis 3

ASH 2023 Analysis 3: Gilead (Kite) and BMS presented real-world (RW) and clinical data updates in r/r LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:

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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:

About The Author

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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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:

About The Author

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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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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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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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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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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ALLO-501A’s ALPHA2 Trial Expands to Europe and Australia; EXPAND Study to Open Enrollment in Europe; ALLO-316’s Initial Results Postponed to Early 2024; Allogene’s Q3 2023 Earnings Call Summary

On Thursday, November 2, Allogene held its Q3 2023 earnings call (press release), highlighting the expansion of the Ph1/2 ALPHA2 trial, evaluating ALLO-501A (allogeneic CD19 CAR-T) in ≥3L LBCL, into Europe and Australia and the opening of recruitment in the Ph2 EXPAND trial, studying the use of ALLO-647 (anti-CD52 mAb) as part of the lymphodepletion regimen, in Europe. Additionally, the company delayed the data readout from ALLO-316’s (allogeneic CD70 CAR-T) Ph1 TRAVERSE trial for r/r ccRCC to early 2024 and noted the upcoming presentation of 2 analyses from the ALPHA2 study at ASH 2023. Below, Celltelligence provides insights on Allogene’s difficulties in the onboarding process for the EXPAND study, while discussing the potential development of the Ph3 ALPHA3 trial in earlier line LBCL and the initial interest of the company in non-oncology indications. 

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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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Adaptimmune Presents Positive Lete-cel and Afami-cel Data in SS and MRCLS

On Tuesday, October 31, Adaptimmune updated its corporate deck and published 2 press releases announcing clinical updates from lete-cel (NY-ESO1 TCR-T) and afami-cel (MAGE-A4 SPEAR-T) to be presented at CTOS 2023 (November 1-4):

About The Author

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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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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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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Cellares and BMS Extend Collaboration to Include a Second CAR-T Asset; Kristin Yarema Appointed as Poseida’s CEO Replacing Mark Gergen

On October 10, Cellares announced an extension of its agreement with BMS to include a second CAR-T Program in Cellares’s Technology Adoption Partnership (TAP) Program (press release). A day earlier, Poseida reported a leadership transition with Kristin Yarema appointed as the new CEO expected to be effective January 1, 2024, while Mark Genger, current CEO, will transition to Executive Chairman of the company (press release). Below, Celltelligence provides insights about the expanded Cellares-BMS collaboration and speculates about which of BMS’s preclinical assets could have been partnered.

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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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