Category Archives: Topics

Thoughts on Novartis’s Agreement with Legend

On Monday, November 13, Legend announced (press release) that it entered into an exclusive WW license agreement with Novartis. Of note, Novartis will gain exclusive rights to Legend’s DLL3 cell therapies, including LB2102 (DLL3 CAR-T), and may apply its T-Charge platform to their manufacturing. Below, Celltelligence provides insights on Novartis’s decision to enter the solid tumor cell therapy space while discussing the competitive landscape of DLL3-targeting SCLC.

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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

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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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Breyanzi sBLA for R/R CLL/SLL Receives FDA Priority Review

On Thursday, November 9, BMS announced (press release) FDA accepted the sBLA for the expansion of Breyanzi’s (CD19 CAR-T) label to include r/r chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The company confirmed that the FDA has granted Priority Review to the application and set a PDUFA date of March 14, 2024. Below, Celltelligence provides insights on the results of the Ph1/2 TRANSCEND CLL 004 trial supporting the application while discussing BMS’s strategy for the hypothetical use of Breyanzi in 2L CLL/SLL.

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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 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

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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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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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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

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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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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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Lyell and CRISPR Tx Present Novel CAR-Ts in Solid Tumors; SITC 2023 Analysis 2

SITC 2023 Analysis 2: Lyell and CRISPR Tx presented preclinical results from their novel cell therapies in solid tumors. 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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Carisma Tx Shows Initial Results from its Collaboration with Moderna; AstraZeneca Presents AZD6422’s Preclinical Development in Gastrointestinal Cancers and a Synergistic Combination of AZD074 with Enzalutamide in Prostate Cancer; SITC 2023 Analysis 1

SITC 2023 Analysis 1: Carisma Tx and AstraZeneca presented preclinical data from their novel cell therapies in solid tumors. 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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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.

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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