Category Archives: CAR-T

No Cell Therapy-Related Updates in October’s CHMP Agenda

On Monday, October 9, the CHMP Agenda for October was released. Of note, no cell therapy-related updates were observed and both Type II Variations applications (T2V) for Abecma (BMS’s BCMA CAR-T) in ≥3L MM and Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥2L MM were absent from the agenda.

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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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You May Have Missed: Gilead Terminates 2 Arms in ZUMA-25 Trial; UPenn Starts Trial in Prostate Cancer with Former Tmunity Asset; A2 Bio Publishes New Study in Solid Tumors; Cartesian to Initiate Trial in SLE

In the past few weeks, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. In this blast, Celltelligence will cover the following topics: 

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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GC012F Achieves 100% sCR in Chinese IIT for NDMM; First R/R MM Patient Dosed with GC012F in the US; AbbVie Terminates Agreement with Caribou

Gracell presented clinical updates of the ongoing GC012F’s (BCMA x CD19 FasTCAR-T) Ph1 IIT in high-risk (HR) transplant-eligible (TE) NDMM patients in China at the International Myeloma Society (IMS) Annual Meeting 2023 (press release). Moreover, on Tuesday, September 26, the company disclosed the dosing of the first patient in the Ph1b/2 trial evaluating GC012F in ≥4L MM in the US (press release). On the same day, Caribou reported AbbVie’s decision to terminate the collaboration agreement for the development of allogeneic cell therapy candidates (Form 8-K). Below, Celltelligence provides insights on GC012F’s clinical development while discussing the impact that the termination of the collaboration may have on Caribou and AbbVie.

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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AMT Designation Program and CDRP Pilot to Facilitate CMC Development of Products; ASGCT 2023 Policy Summit Analysis (Blast 2/2)

ASGCT 2023 Policy Summit Analysis 2: CMC information plays a fundamental role in the development and regulation of cell and gene therapies (CGTs), which has motivated the generation of new policies to facilitate and expedite its evaluation. Celltelligence is publishing a two-part series discussing the strategies the FDA is following to keep up with innovation in the CGT field and providing insights about their relevance in the cell therapy space. In this second blast, 2 new non-CGT-specific FDA policy initiatives focused on addressing CMC challenges 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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The Office of Therapeutic Products Bets on Communication; New Cell and Gene Therapy Access Model to Be Tested; ASGCT 2023 Policy Summit Analysis (Blast 1/2)

ASGCT 2023 Policy Summit Analysis 1: Cell and gene therapies (CGTs) have emerged as novel treatment options with unique characteristics that differ from previously approved therapies, which has motivated the generation of new regulatory processes and policies. The ASGCT 2023 Policy Summit delved into some of the strategies the FDA is following to keep up with innovation in the CGT field. Celltelligence will publish a two-part series discussing these new approaches and providing insights about their relevance in the cell therapy space. In this first blast, 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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KarMMa-9 Trial Design Disclosed; Plans to Accelerate Cell Therapy Development in Multiple Autoimmune Diseases; Innovative and Diverse Preclinical Pipeline Presented; BMS’s 2023 R&D Day Summary

On Thursday, September 14, BMS held its 2023 R&D day (press release / presentation) disclosing Abecma’s (BMS / 2seventy’s BCMA CAR-T) Ph3 KarMMa-9 trial design in HR NDMM. The company also highlighted its plans to initiate BMS-986393’s (CC-95266; GPRC5D CAR-T) registrational trial in H1 2024 as well as its intention to submit an IND for the investigation of BMS-986353 (CC-97540 CD19 NEX-T CAR-T) in multiple sclerosis (MS) in September 2023. Additionally, BMS shared its full cell therapy pipeline, including highly innovative and diverse preclinical assets. Below, Celltelligence provides insights on KarMMa-9 design and the company’s new GPRC5D x BCMA dual targeting CAR-T for MM, while discussing BMS’s market opportunity in the autoimmune disease cell therapy space.

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

On Friday, September 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’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 ≥2L MM. Moreover, recall that Abecma (BMS / 2seventy’s BCMA CAR-T) was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the September CHMP meeting with updated EU regulatory timelines for both cell therapies. 

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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Carvykti Appears in the CHMP Agenda; September’s CHMP Agenda

On Monday, September 11, the CHMP agenda for September was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM, while Abecma’s (BMS’s BCMA CAR-T) Type II Variation for ≥3L 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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You May Have Missed: Gilead to Collaborate in the Development of TmCD19-IL18; Celularity Partners with Regeneron; Mustang Bio Presents First Data from MB-106’s Multicenter Trial; Anticipated Enrollment of YTB323’s SLE Trial Increased- August 2023 Recap (Blast 2/2)

In August 2023, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. Celltelligence decided to publish a two-part series discussing the news and providing insights about their importance in the cell therapy space. In this second summary, 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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You May Have Missed: CARsgen Partners with Moderna; AZ to Collaborate in the Development of a New CAR-T in Solid Tumors; Gilead to Evaluate Novel Dual CAR-T; Poseida and Roche Publish P-CD19CD20-ALLO1’s New Trial; Germany’s G-BA Completes Carvykti’s Reimbursement – August 2023 Recap (Blast 1/2)

In August 2023, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. Celltelligence will publish a two-part series discussing the news and providing insights about their importance in the cell therapy space. In this first summary, the following topics are covered:

About The Author

The Celltelligence Team

|
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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