Tag Archives: CAR-T

Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Anito-cel Elicits Improved Responses Across HR Subgroups; Gracell’s GC012F Shows Best-In-Class Safety and Efficacy Profiles; Increased Lymphodepleting Dose Enhances P-BCMA-ALLO1’s Responses Significantly; ASH 2023 Analysis 6

ASH 2023 Analysis 6: Arcellx, Gracell, and Poseida presented updated clinical data about their cell therapies in multiple myeloma. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below: 

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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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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:

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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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Thoughts on Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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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JPM 2023 Analysis Day 3: Century Tx, Atara Bio, and Precigen

On the third day of the JPM 2023, Celltelligence covered presentations by Century Tx (press release / webcast / presentation), Atara Bio (webcast / presentation), and Precigen (press release / presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below.

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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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Updated Results from UCART123 and UCARTCS1 at ASH 2022; UCART20x22 and UCART22 Manufactured In-House; Cellectis’s Q3 2022 Earnings Call Summary

On Friday, November 4, Cellectis held its Q3 2022 earnings call (press release) highlighting that preliminary clinical data from UCART123’s (allogeneic CD123 CAR-T) Ph1 AMELI-01 study in r/r AML and preclinical results from UCARTCS1 (allogeneic CS1 CAR-T) will be presented at ASH 2022 (Dec 10 – 13). Of note, no major clinical updates were provided from UCART20x22 (allogeneic CD20 x CD22 CAR-T) or UCART22 (allogeneic CD22 CAR-T). Below, Celltelligence provides insights on UCART123’s anticipated clinical results, while discussing the progress of other pipeline assets.

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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 Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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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Thoughts on Poseida’s Strategic Global Collaboration with Roche

On Wednesday, August 3, Poseida announced (press release / presentation) a strategic global collaboration with Roche to develop and commercialize existing and novel allogeneic cell therapies for hematologic indications. Of note, Poseida will receive $110M upfront and further milestone payments potentially exceeding $6B in aggregate value. Below, Celltelligence provides insights on Roche’s shift in interest regarding cell therapies, while discussing Poseida’s partnering 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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

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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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Breyanzi Included in the NCCN Guidelines for the Treatment of 2L DLBCL

On Tuesday, July 12, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas were updated (NCCN Guidelines in B-Cell Lymphoma) to include Breyanzi’s (BMS’s CD19 CAR-T) treatment in 2L DLBCL. Of note, Breyanzi is now recommended as a 2L therapy for patients who have primary refractory disease or have relapsed within 12 months, as well as patients who are non-candidates for transplant. Below, Celltelligence provides insights on Breyanzi’s inclusion in the NCCN Guidelines, while discussing how Yescarta’s (Gilead / Kite’s CD19 CAR-T) NCCN recommendation.

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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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