Category Archives: CD19

BMS’s Cell Therapy Franchise Sales Decrease; KarMMa-9 Initiated; The FDA Clears BMS-986353’s IND in MS; First Patients in SLE Trial Dosed; BMS’s Q3 2023 Earnings Call Summary

On Thursday, October 26, BMS held its Q3 2023 earnings call (press release / presentation) disclosing a significant revenue decrease for Abecma (BCMA CAR-T) and a decline in Breyanzi (CD19 CAR-T) sales. Additionally, BMS confirmed the dosing of the first patient in the Ph1 trial evaluating BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in severe refractory systemic lupus erythematosus (SLE), while announcing IND clearance from the FDA to start a trial in multiple sclerosis (MS). Below, Celltelligence provides insights on the potential causes behind the Abecma and Breyanzi sales drops while discussing the initiation of the Ph3 KarMMa-9 trial in NDMM and BMS’s fast progress in the autoimmune disease space.

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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 Trial in SLE on Track to Be Initiated in Early 2024; Obe-cel’s Development in Oncology Could Accelerate its Path to Market in SLE; Autolus to Leverage Infrastructure Established for ALL in Autoimmune Diseases

On Tuesday, October 24, Autolus held a virtual event (press release / presentation) highlighting its intention to initiate a Ph1 trial evaluating obe-cel (CD19 CAR-T) in systemic lupus erythematosus (SLE) in early 2024, while disclosing the company’s strategy in the autoimmune disease space. Below, Celltelligence provides insights on Autolus’s plans for autoimmune diseases and discusses how obe-cel’s previous development in oncology could be a potential advantage versus its competitors in the space.

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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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Kymriah’s Revenue Continues to Decrease; No Updates on Cell Therapy Programs; Novartis’s Q3 2023 Earnings Call Summary

On Tuesday, October 24, Novartis held its Q3 earnings call (press release / presentation) reporting $124M in Kymriah (CD19 CAR-T) WW sales, while the company did not provide any update on its cell therapy programs. Below, Celltelligence provides insights on Kymriah’s Q3 2023 revenue while discussing changes observed in the company’s trial evaluating YTB323 in systemic lupus erythematosus (SLE).

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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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Comparative Analyses Suggest Yescarta is More Effective than Epkinly and Columvi but Less Safe; ESMO 2023 Analysis 1

ESMO 2023 analysis 1: Gilead presented two posters, highlighting the results of two Matching-Adjusted Indirect Comparison (MAIC) studies comparing Yescarta (axi-cel; CD19 CAR-T) with Epkinly (epcoritamab; AbbVie / Genmab’s CD20xCD3 BsAb) or Columvi (glofitamab; Roche’s CD20xCD3 BsAb). Below, Celltelligence provides insights on the results of these comparative analyses meanwhile inquiring about the characteristics and limitations of the studies. 

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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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Gilead to Initiate Trial to Evaluate New KITE-197 Asset in LBCL; AstraZeneca to Start Clinical Development of AZD5851 in HCC patients

On October 12, a new Gilead (Kite)-sponsored Ph1 trial investigating KITE-197, a novel asset with an undisclosed target, in r/r LBCL patients was posted on CT.gov. Additionally, on October 16, a new AZ-sponsored Ph1/2 ATHENA trial evaluating AZD5851 (TGFβRIIDN armored GPC3 CAR-T) in ≥2L GPC3 positive advanced / recurrent HCC was detected. Below, Celltelligence discusses the potential targets of KITE-197 while evaluating the relevance of the new AZ-sponsored clinical trial and the competitive advantage of AZD5851 over other GPC3 CAR-Ts.

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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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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.

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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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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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