Category Archives: Uncategorized

ALLO-501A’s ALPHA2 Trial to Start Enrollment Ex-US; EXPAND Continues Recruiting Slowly; ALPHA3 Trial Redefined; Allogene’s Q2 2023 Earnings Call Summary

On Wednesday, August 2, Allogene held its Q2 2023 earnings call (press release) highlighting the progress of ALLO-501A’s (allogeneic CD19 CAR-T) Ph1/2 ALPHA2 trial in ≥3L LBCL and the EMA Clinical Trial Application approval to expand the study to Europe. Below, Celltelligence provides insights on ALPHA2 and Ph2 EXPAND trial timelines, while discussing the company’s potential strategy for the Ph3 ALPHA3 trial in LBCL.

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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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Precision Receives Feedback from the FDA on Azer-cel’s Registrational Pathway

On Thursday, July 27, Precision Biosciences announced (press release) the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T). Moreover, the company disclosed discussions with multiple potential strategic partners for the development of its cell therapy assets. Below, Celltelligence provides insights on azer-cel’s potential in LBCL, while comparing the asset with its main allogeneic competitors.

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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 Sales Decrease While Breyanzi Revenue Keeps Growing; Plans to Start a BMS-986393 Registrational Trial; BMS Invests in Immatics; BMS’s Q2 2023 Earnings Call Summary

On Thursday, July 27, BMS held its Q2 2023 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales increase while reporting a revenue decrease for Abecma (BCMA CAR-T). Furthermore, the company underscored clinical and regulatory milestones of its cell therapy assets, disclosing a new potentially registrational trial for BMS-986393 (CC-95266; GPRC5D CAR-T). Finally, on Monday, July 24, Immatics announced a $35M equity investment from BMS (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed cell therapy assets in Q2 2023 and the company’s regulatory plans for its CAR-T programs.

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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’s T2V Receives an RSI; When Could Abecma and Carvykti Receive a CHMP Positive Opinion? June CHMP Highlights

On Friday, June 23, 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 Request for Supplementary Information (RSI) for its assessment in ≥3L MM. Moreover, recall that Carvykti (JNJ / Legend’s BCMA CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ to expand its label to ≥2L MM on Monday’s CHMP agenda. Below, Celltelligence provides insights on the June CHMP meeting with updated EU regulatory timelines for both cell therapies.

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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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Impressive Results for Breyanzi in ≥3L FL and ≥3L MCL; MB-106 Demonstrates Excellent Efficacy and Safety in R/R FL

On Saturday, June 17, BMS presented results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial in r/r FL patients and a primary analysis from the MCL cohort of the Ph1 TRANSCEND NHL 001 trial at ICML 2023. Moreover, Mustang Bio presented data from the FL cohort dosed with MB-106 (CD20 CAR-T) in the single-center Ph1/2 trial that led to the initiation of a registrational Ph1/2 trial for the treatment of r/r B-NHL or CLL in the same conference. Below, Celltelligence provides insights on how Breyanzi’s results compare to its key competitor CD19 CAR-Ts in ≥3L FL and ≥3L MCL, and discusses potential approval timelines for both indications in the US while analyzing which assets could rival MB-106 to become the first approved CD20 CAR-T.

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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? Carvykti Starts EMA Assessment in ≥2L MM; June’s CHMP Agenda

On Monday, June 19, the CHMP agenda for June was released. Of note, Abecma (BMS’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while Carvykti (JNJ / Legend’s BCMA CAR-T) was listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ to expand its label to ≥2L MM.

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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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2Seventy Bio’s SC-DARIC-33 Program Paused

On Wednesday, June 14, 2seventy bio announced the pause of the Ph1 PLAT-08 trial, evaluating SC-DARIC33 (drug-regulated CD33 CAR-T) for pediatric and young adult r/r CD33+ AML by Seattle Children’s Hospital, sponsor of the study. The company informed the decision was taken in response to a recent Grade 5 SAE and was followed by the required notification to the FDA (press release). Below, Celltelligence provides insights on SC-DARIC-33’s biological profile and potential risks associated with the use of rapamycin while hypothesizing about the future of 2seventy programs 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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GC012F Demonstrates a Promising Profile in ≥3L DLBCL Patients; ALYCANTE Trial Confirms Yescarta’s Excellent Efficacy in TI 2L LBCL Patients; NKX019 Shows Potential in NHL Patients; EHA 2023 Analysis 3

EHA 2023 Analysis 3: Gracell and Nkarta presented clinical updates from their programs in B-cell malignancies. Moreover, the French Lymphoma Academic Research Organisation (LYSARC) provided the final results of Yescarta’s (Gilead’s (Kite) CD19 CAR-T) ALYCANTE trial. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Promising Efficacy Data from BMS’s GPRC5D CAR-T in ≥4L MM; Abecma Demonstrates Superiority Vs SOC in ≥3L MM Across All High-Risk Subgroups; Preliminary Clinical Data from Innovent’s P329G-CAR-T in ≥4L MM; EHA 2023 Analysis 2

EHA 2023 Analysis 2: BMS / 2seventy bio and Innovent / Roche presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations, where the first topic also includes an evidence roundup of the PDUFA date for Janssen’s talquetamab. The following topics are covered:

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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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Promising Preliminary GC007g Efficacy Data in B-ALL Patients that Relapsed Post-Allo-HSCT; Prior CD19-Targeting Treatments Could Affect Tecartus Efficacy in R/R ALL; UCART22 Shows 50% CR in r/r B-ALL Patients Failing Previous CD19 CAR-T Therapy; EHA 2023 Analysis 1

EHA 2023 Analysis 1: Gracell, Gilead (Kite), and Cellectis presented clinical updates from their programs in B-ALL. 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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