Category Archives: Allogeneic

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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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 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 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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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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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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Allogene Overland Appoints Shuyuan Yao as CEO

On Monday, June 21, Allogene announced (press release) that Shuyuan Yao has been appointed as CEO of Allogene Overland Biopharm. Below, Celltelligence provides insights on how Shuyuan Yao’s vast cell therapy experience could position Allogene Overland for rapid growth in Greater China and throughout the Asia-Pacific region.

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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 Gilead’s Collaboration with Shoreline to Develop iPSC-derived Allogeneic Cell Therapies

On Thursday, June 17, Gilead (Kite) announced (press release) a strategic collaboration with Shoreline Biosciences to develop novel allogeneic cell therapies. Of note, the partnership will focus on the development of iPSC-derived CAR-NK therapies for hematological malignancies, with Gilead (Kite) having the possibility to include an iPSC-derived CAR-macrophage (CAR-M) program. Below, Celltelligence provides insights on Gilead’s (Kite) latest collaboration and the potential advantages CAR-NKs and CAR-Ms may have over CAR-T therapies.

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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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