Category Archives: Topics

Why Poseida+Cellares Matters to Novartis; Poseida’s P-BCMA-ALLO1 Allogeneic Ph1 Trial in R/R MM

On Wednesday, July 14, Cellares announced (press release) that Poseida Therapeutics has joined their Early Access Partnership Program (EAPP). Of note, the EAPP was created in 2020 to provide participants visibility and early access to Cellares’s Cell Shuttle manufacturing platform. On the same day, a new Poseida P-BCMA-ALLO1 (allogeneic BCMA CAR-T) Ph1 trial for r/r MM was observed on CT.gov. Below, Celltelligence provides insights on how Poseida’s early access to the Cell Shuttle may increase the likelihood that Novartis could acquire Poseida as well as thoughts on Poseida’s new P-BCMA-ALLO1 Ph1 study.  

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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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No Mention of Breyanzi or Cilta-cel in July’s CHMP Agenda; Will Abecma be Approved Before September?

On Monday, July 19, the CHMP agenda for July was released. Of note, no major updates were observed for Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides likely EU approval timelines for Abecma, Breyanzi, and cilta-cel.

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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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Autolus Appoints Edgar Braendle as Chief Development Officer

On Thursday, July 15, Autolus announced (press release) the appointment of Edgar Braendle as Chief Development Officer (CDO). Below, Celltelligence provides insights on how Edgar Braendle’s vast oncology experience could accelerate the development and commercialization of Autolus’s lead asset, obe-cel (CD19 CAR-T, formerly AUTO1).

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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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First Patient Dosed With Precision’s Stealth Cell PBCAR19B

On Thursday, July 1, Precision BioSciences announced (press release) that the first patient has been dosed with PBCAR19B (stealth allogeneic CD19 CAR-T) in the Ph1 trial for r/r NHL. Below, Celltelligence discusses Precision’s stealth cell program while providing insights on how Precision could apply learnings from PBCAR19B’s dosing strategy to other programs.

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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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Allogene’s TurboCAR ALLO-605 Receives Fast Track Designation From the FDA

On Wednesday, June 30, Allogene announced (press release) that the FDA has granted Fast Track designation to ALLO-605 (allogeneic BCMA TurboCAR) for r/r MM. Furthermore, management noted that ALLO-605’s Ph1 IGNITE trial was initiated in Q2 2021. Below, Celltelligence provides insights on how ALLO-605 could benefit from Fast Track designation while discussing Allogene’s TurboCAR program.

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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’s Ph3 ZUMA-7 Trial Demonstrates Improved Efficacy of Yescarta vs SoC in 2L DLBCL; Which CD19 CAR-T Treating DLBCL Will Move Into an Earlier Line of Therapy First? First Patient Dosed With Precision’s PBCAR269A + Nirogacestat Combination

On Monday, June 28, Gilead (Kite) reported (press release) topline results from the primary analysis of Yescarta (CD19 CAR-T) vs the SoC in the Ph3 ZUMA-7 trial for 2L r/r DLBCL patients. Furthermore, Precision BioSciences and SpringWorks announced (press release) that the first patient has been dosed with PBCAR269A (BCMA CAR-T) + nirogacestat (GSI) in the Ph1/2a trial for r/r MM patients. Below, Celltelligence provides insights on how Yescarta’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Breyanzi (BMS) while discussing Precision’s and key competitor Allogene’s clinical progress combining a GSI with their lead BCMA CAR-T assets.

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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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Thoughts on Abecma’s Positive CHMP Opinion for a Conditional Approval in ≥4L R/R MM

On Friday, June 25, BMS announced (press release) that the CHMP adopted a positive opinion for Abecma’s (idecabtagene vicleucel; BCMA CAR-T) conditional marketing authorization in ≥4L r/r multiple myeloma (MM). If approved by the EC, Abecma would become the first CAR-T treatment approved for r/r MM in Europe. Below, Celltelligence provides thoughts on Abecma’s positive CHMP opinion and its potential launch strategy within Europe, while comparing Abecma’s regulatory status between the EU and the UK.

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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 BMS’s Abecma in ≥4L r/r MM

On Friday, June 25, the CHMP adopted (press release) a positive opinion for Abecma (idecabtagene vicleucel; BCMA CAR-T) in ≥4L relapsed/refractory multiple myeloma (MM). The Celltelligence team will provide a detailed analysis in the coming days about Abecma’s positive CHMP opinion and BMS’s potential launch strategy within Europe.

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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Yescarta / FKC876 Approved in China for Adult Patients With ≥3L R/R DLBCL

On Wednesday, June 23, Gilead announced (press release) that Yescarta (FKC876 / Yikeilen) has been approved by the Chinese NMPA for adult patients in ≥3L r/r DLBCL. Of note, Yescarta has become the first approved CAR-T in China. Below, Celltelligence provides insights on Yescarta’s Chinese regulatory history including which CAR-T could be approved next, while discussing the potential hurdles facing CAR-T reimbursement in China.

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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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JNJ / Legend Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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