Category Archives: Uncategorized

Servier Discontinues Partnership with Allogene

On Wednesday, September 21, Allogene reported (SEC Filing) that Servier has discontinued its involvement in the development of allogeneic CD19-directed assets, including Allogene’s most advanced candidates such as ALLO-501, ALLO-501A, and UCART19. Below, Celltelligence provides insights on how the lack of an ex-US licensing partner could affect Allogene’s pipeline development.

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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 JNJ Change the Treatment Paradigm in MM? Spotlight on JNJ’s MM Franchise

During 2022, JNJ’s (Janssen) MM franchise achieved major regulatory milestones that have positioned the company as a key player in the MM landscape. Carvykti’s (cilta-cel; BCMA CAR-T) US approval, EU approval, and Tecvayli’s (teclistamab; BCMA x CD3 bispecific antibody) recent conditional marketing authorization in the EU could potentially allow JNJ to change the treatment paradigm in MM. Below, Celltelligence provides insights on how JNJ could leverage its large MM portfolio and pipeline to disrupt the current SOC regimens for MM, as well as what may be going on with Tecvayli’s US regulatory delay.

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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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CHMP Adopts Positive Opinion for Yescarta; Breyanzi Absent from September’s CHMP Highlights

On Friday, September 16, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Yescarta (Gilead / Kite’s CD19 CAR-T) in 2L LBCL. Additionally, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides insights on Yescarta’s positive opinion, while discussing updated EU timelines for Breyanzi.

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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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New Tecartus Ph2 Trial (ZUMA-25) for R/R Rare B-cell Malignancies

On Tuesday, September 13, a new Gilead / Kite-sponsored Ph2 trial (ZUMA-25) evaluating Tecartus (autologous CD19 CAR-T) in rare B-cell malignancies was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing how Gilead could leverage Tecartus’s indication expansion strategy to differentiate from its main 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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Type II Variations for Yescarta and Breyanzi Listed in September’s CHMP Agenda

On Monday, September 12, the CHMP agenda for September was released. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r DLBCL and high-grade B-cell lymphoma (HGBL), and 2L DLBCL Transplant Intended (TI) patients, respectively.

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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: Indications Table for BCMA and CD19 CAR-Ts US Approvals and Submissions

New content: The Celltelligence team has created a BCMA CAR-T indications table for estimated US approvals and submissions following key Q2 2022 earnings presentations and recent press releases (see below for download). Of note, no updates were observed in Celltelligence’s CD19 CAR-T indications table.

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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 Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’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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Gilead / Kite Expands Cell Therapy Operations in Brazil, Singapore, and Saudi Arabia

On Wednesday, August 31, Gilead (Kite) announced the expansion of their cell therapy operations to Brazil, Singapore, and Saudi Arabia (press release). Below, Celltelligence provides insights on how Yescarta (Kite’s CD19 CAR-T) could quickly challenge Kymriah’s (Novartis’s CD19 CAR-T) market exclusivity in these geographies, while discussing Kite’s potential manufacturing expansion strategy.

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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Gracell’s GC012F IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL 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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P-PSMA-101 Clinical Program Delayed; Poseida’s Global Collaboration with Roche; Poseida Q2 2022 Earnings Summary

On Thursday, August 11, 2022, Poseida released their Q2 2022 results (press release) highlighting anticipated clinical updates for H2 2022 and the recent partnership with Roche. Below, Celltelligence provides insights on a potential delay for Poseida’s P-PSMA-101 (autologous PSMA CAR-T) program, 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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