Category Archives: Autologous

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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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 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 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 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 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 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:

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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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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.

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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):

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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 BLA Submission Remains on Track for YE 2023; YTB323 and Obe-cel to Compete on Safety in SLE; AUTO6NG’s Trial in Neuroblastoma to Be Initiated by YE 2023; Clinical Results of AUTO8 at ASH; Autolus’s Q3 2023 Earnings Call Summary

On Thursday, November 2, Autolus held its Q3 2023 earnings call (press release / presentation) highlighting that the obe-cel (CD19 CAR-T) BLA in r/r ALL remains on track to be submitted by YE 2023. The company also disclosed the initiation of an obe-cel Ph1 trial in pediatric ALL by YE 2023 to support its MAA with the EMA, while disclosing MHRA’s approval for the evaluation of AUTO6NG (GD2 CAR-T) in the Ph1 MAGNETO trial in pediatric r/r neuroblastoma. Additionally, Novartis will present initial safety data of YTB323’s (CD19 T-Charge CAR-T) Ph1/2 trial in SLE at ACR 2023. Below, Celltelligence provides insights on the regulatory pathway of Autolus’s leading cell therapy while discussing the potential of obe-cel and AUTO8 (BCMA x CD19 CAR-T) in the autoimmune disease space compared with Novartis’s YTB323.

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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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