Category Archives: Topics

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 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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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-012’s IND Cleared by the FDA; Caribou Joins the AML Race

On Wednesday, October 18, Caribou announced CB-012’s (allogeneic CLL-1 CAR-T; PD-1 KO + B2M KO + TCR KO + B2M-HLA-E KI) IND clearance by the FDA to start a trial in 2-4L AML. Below, Celltelligence provides insights on the trial design while discussing the potential advantages of Caribou’s AML program over 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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Carvykti’s Revenue Continues to Increase; CARTITUDE-6 Starts Recruitment; JNJ’s Q3 2023 Earnings Call Summary

On Tuesday, October 17, JNJ held its Q3 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth and reiterated the measures implemented to raise its manufacturing capacity. Moreover, on October 13, the status of the Ph3 CARTITUDE-6 trial was updated on CT.gov to report recruitment initiation. Below, Celltelligence provides insights on the increase in Carvykti sales and evaluates the potential of its revenue to further grow in the next quarters while discussing the initiation of the CARTITUDE-6 trial.

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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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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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Cellares and BMS Extend Collaboration to Include a Second CAR-T Asset; Kristin Yarema Appointed as Poseida’s CEO Replacing Mark Gergen

On October 10, Cellares announced an extension of its agreement with BMS to include a second CAR-T Program in Cellares’s Technology Adoption Partnership (TAP) Program (press release). A day earlier, Poseida reported a leadership transition with Kristin Yarema appointed as the new CEO expected to be effective January 1, 2024, while Mark Genger, current CEO, will transition to Executive Chairman of the company (press release). Below, Celltelligence provides insights about the expanded Cellares-BMS collaboration and speculates about which of BMS’s preclinical assets could have been partnered.

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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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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

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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 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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