Category Archives: CAR-T

The EC Grants Abecma (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, August 19, BMS announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Abecma (BCMA CAR-T) in ≥4L r/r MM. Below, Celltelligence provides insights on Abecma’s conditional approval in the EU while discussing how BMS’s manufacturing strategy could impact Abecma’s TATs in Europe.

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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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Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and cilta-cel.

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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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Precision BioSciences Provides No Major Clinical Updates; Precision Q2 2021 Earnings Call Summary

On Thursday, August 12, Precision BioSciences reported their Q2 2021 results (press release) highlighting data presented at ASCO 2021 from PBCAR0191’s Ph1/2a trial in r/r NHL and ALL. Furthermore, management confirmed the dosing of the first patient in both PBCAR19B (stealth CD19 CAR-T) and PBCAR269A (BCMA CAR-T) programs. Below, Celltelligence provides details on Precision’s upcoming milestones.

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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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Ziopharm’s RPM CD19 CAR-T Ph1 Trial in Taiwan Paused; Clinical Programs Continue to Face Delays; Ziopharm Q2 2021 Earnings Call Summary

On Monday, August 9, Ziopharm held their Q2 2021 earnings call (press release / presentation) highlighting that their TCR-T Library program is anticipated to dose the first patient in Q4 2021. Furthermore, management disclosed that their RPM CD19 CAR-T Ph1 trial for lymphoid malignancies in Taiwan will be paused until the manufacturing process is optimized. Below, Celltelligence provides insights on how Ziopharm’s manufacturing strategy may strengthen their TCR-T Library program while discussing the significance of their RPM CD19 CAR-T program delay.

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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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bluebird’s Oncology Newco on Track to Launch in Q4 2021; Autolus’s obe-cel Granted PIM Designation by the MHRA; bluebird bio Q2 2021 Earnings Call Summary

On Monday, August 9, bluebird bio held their Q2 2021 earnings call (press release / presentation) highlighting Abecma’s successful US launch and providing updates on bluebird’s upcoming business separation. Additionally, management commented on bluebird’s recent manufacturing alliance with Resilience. On the same day, Autolus announced (press release) that obe-cel (CD19 CAR-T) has received Promising Innovative Medicine (PIM) designation from the MHRA in r/r adult ALL.

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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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Cellectis’s First Solid Tumor CAR-T Advancing to the Clinic; Raleigh GMP Facility on Track to Start Production by YE 2021; Cellectis Q2 2021 Earnings Call Summary

On Friday, August 6, Cellectis held their Q2 2021 earnings call (press release) highlighting that their novel UCART programs, UCART20x22 (CD20 x CD22 CAR-T) and UCARTMESO (mesothelin CAR-T), are anticipated to enter the clinic in 2022. Furthermore, Cellectis confirmed that their GMP manufacturing facility in Raleigh is expected to begin production by YE 2021. Below, Celltelligence provides insights on Cellectis’s clinical program progress while discussing how their fully in-house production approach may minimize potential manufacturing backlogs due to viral vector shortage.

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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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Autolus Confirms Obe-cel’s Ph1b/2 FELIX Trial Readout in 2022; Could Obe-cel be Approved by Early 2023? Yescarta Gains Reimbursement Approval in Australia and Gilead (Kite) Continues Expanding to Novel Cell Platforms with Appia Bio’s Collaboration; Autolus Q2 2021 Earnings Call Summary

On Thursday, August 5, Autolus held their Q2 2021 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) Ph1b/2 FELIX study in r/r ALL readout is on track for 2022. On the same day, Gilead (Kite) announced Yescarta’s (CD19 CAR-T) reimbursement approval in Australia (press release) and a collaboration with Appia Bio for the development of CAR invariant natural killer T (CAR-iNKT) cells for hematological malignancies (press release).

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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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ALLO-501A Pivotal Trial on Track to Start by YE 2021; Allogene Prepares for Clinical Manufacturing; Allogene Q2 2021 Earnings Call Summary

On Wednesday, August 4, Allogene held their Q2 2021 earnings call (press release) highlighting clinical updates for their CD19 and BCMA CAR-T programs, and confirmed their plans to initiate cGMP manufacturing in their new Cell Forge 1 facility by YE 2021. Below, Celltelligence will discuss Allogene’s pipeline updates while providing thoughts on how the company may be preparing for ALLO-501A’s potential regulatory approval.

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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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New Gilead KITE-363 (CD19 x CD20 CAR-T) Ph1 Trial in R/R BCL Posted

On Wednesday, August 4, a new Gilead (Kite) Ph1 trial evaluating KITE-363 (autologous CD19 x CD20 CAR-T) in r/r B cell lymphoma (BCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing the significance of Gilead (Kite) developing a dual-targeting CAR-T.

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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 Consolidates Their Position as Market Leader; Could Tecartus in R/R Adult ALL Receive A Positive CHMP Opinion By YE 2021? Gilead’s Q2 2021 Earnings Call Summary

On Thursday, July 29, Gilead held their Q2 2021 earnings call (press release / presentation) highlighting an increase in overall revenue for their cell therapy franchise, while discussing the benefits of a potential FDA approval for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Furthermore, management highlighted the submission of a Type II variation to the EMA for Tecartus (CD19 CAR-T) in r/r adult ALL. Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s and Tecartus’s expansion into new indications to consolidate their position as a cell therapy market leader, while discussing likely EU approval timelines for Tecartus.

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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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