Category Archives: CAR-T

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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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 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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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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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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Kite to Collaborate with Epic Bio to Develop New Therapies for Cancer

On Tuesday, October 31, Gilead (Kite) announced a research collaboration and license agreement with Epicrispr Biotechnologies (Epic Bio) for the use of Epic Bio’s proprietary gene regulation platform to develop next-generation cancer cell therapies (press release). Below, Celltelligence provides insights on how Gilead could leverage Epic Bio’s platform to develop better cell therapies for hematological diseases.

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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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