Tag Archives: CD19

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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The FDA Clears NKX019’s IND in Lupus Nephritis; Nkarta Partners With Lupus Tx; Company Amends NKX019’s Trial in B-Cell Malignancies

On Tuesday, October 17, Nkarta held a conference call (webcast) highlighting the IND clearance from the FDA to evaluate NKX019 (CD19 CAR-NK) in refractory lupus nephritis (rLN) (press release) and providing clinical updates and anticipated milestones for its CAR-NK programs in hematologic malignancies. On the same day, Lupus Tx announced a partnership with Nkarta to support the early development of NKX019 in lupus (press release). Below, Celltelligence provides insights on the clinical advantages of the use of CAR-NKs in the autoimmune disease setting while discussing Nkarta’s amendments to the Ph1 trial evaluating NKX019 in B-cell malignancies.

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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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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.

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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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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.

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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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Updated Results of BRL-201 in R/R B-NHL; MeiraGTx and CERo Present Innovative Cell Therapy Technologies; ASGCT Spotlight on Immuno-Oncology 2023 Analysis

ASGCT Spotlight on Immuno-Oncology 2023 Analysis: BRL Medicine reported clinical updates from BRL-201’s (CD19 Quikin CAR-T) Ph1 trial in r/r B-NHL patients, while MeiraGTx and CERo Tx introduced their innovative technologies.

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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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IASO, AbClon, Parasol and Affyimmune Present Promising Results of Their New Cell Therapies in Hematological and Solid Tumor Indications; ASCO 2023 Analysis 6

ASCO 2023 Analysis 6: IASO Biotherapeutics, AbClon, Parasol Biotech, and Affyimmune presented clinical updates from their novel CAR-T assets. 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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Analysis of Breyanzi in CLL/SLL Demonstrates Long Survival in Patients Achieving CR; Yescarta Reduces Risk of Death in 2L LBCL; Tecartus’s RW Study Shows Improved Results when Compared with ZUMA-2; ASCO 2023 Analysis 5

ASCO 2023 Analysis 5: BMS and Gilead (Kite) presented clinical outcomes from their autologous CD19 CAR-Ts in hematological malignancies. 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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CB-010 to Be Evaluated in 2L LBCL; CB-011’s Ph1 Trial in MM Initiated; No Updates on Poseida’s Milestones for 2023; Caribou’s and Poseida’s Q1 2023 Earnings Call Summary

On Tuesday, May 9, the following companies released their Q1 2023 results and business updates:

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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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The EC Grants Breyanzi Marketing Authorization in 2L LBCL

On Wednesday, May 3, BMS announced (press release) that the European Commission (EC) has granted Breyanzi (CD19 CAR-T) approval for the treatment of ≥2L LBCL patients that have relapsed within 12 months or that are refractory to 1L chemoimmunotherapy. Below, Celltelligence provides insights on Breyanzi’s approval in the EU, while comparing it with its key competitor Yescarta (Gilead’s CD19 CAR-T).

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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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