Category Archives: CAR-T

Abecma’s Viral Vector Shortage; Could JNJ Take Advantage? BMS Q2 2021 Earnings Call Summary

On Wednesday, July 28, BMS held their Q2 2021 earnings call (press release / presentation), highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) strong demand following their recent US approval, while discussing Abecma’s manufacturing bottleneck due to a shortage of viral vector. On the same day, bluebird bio announced (press release) a strategic alliance with Resilience for the sale of bluebird’s lentiviral manufacturing facility in North Carolina. Below, Celltelligence provides insights on how Abecma’s upcoming approval in the EU could impact BMS’s viral vector shortage and if JNJ could take advantage for cilta-cel’s launch.

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New Legend Ph1 Trial for LCAR-T2C (CD4 CAR-T) in R/R T Cell Lymphoma Posted

On Thursday, July 22, a new Legend-sponsored Ph1 trial in China evaluating LCAR-T2C (CD4 CAR-T) for r/r T cell lymphoma (TCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing Legend’s CD4 CAR-T global clinical development, and how LCAR-T2C compares to Autolus’s AUTO4 program.

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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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Is Competition from Breyanzi Responsible for a Decline in Kymriah’s Sales? Cilta-cel Remains on Track to Gain FDA Approval by EOY; Novartis and JNJ Q2 2021 Earnings Call Summaries

On Wednesday, July 21, Novartis held their Q2 2021 earnings presentation (press release / presentation) highlighting Kymriah’s sales decline. Of note, no major clinical or regulatory updates were reported. On the same day, JNJ presented their Q2 2021 financial results (press release  / presentation) highlighting the submission of cilta-cel’s (BCMA CAR-T) MAA to the EMA. Below, Celltelligence provides insights on how Breyanzi’s approval in the US could have negatively impacted Kymriah’s Q2 2021 sales while discussing cilta-cel’s potential US and EU regulatory timelines.

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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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BioNTech Acquires Kite’s TCR-T Platform and Manufacturing Facility; Is Kite Pivoting Away from TCR-Ts?

On Monday, July 19, Gilead (Kite) announced (press release) that BioNTech will acquire Kite’s individualized TCR platform and manufacturing facility in Gaithersburg, MD. Below, Celltelligence provides insights on Gilead’s (Kite) potential approach to treat solid tumors while discussing how BioNTech’s acquisition may quickly advance their pipeline by expanding their US manufacturing footprint.

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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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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

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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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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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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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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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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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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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