Category Archives: Uncategorized

Allogene and MD Anderson Announce a 5-Year Collaboration to Develop Allogeneic CAR-Ts

On Thursday, October 15, Allogene announced (press release) a five-year collaboration with the MD Anderson Cancer Center for the preclinical and clinical development of Allogene’s AlloCAR-T candidates. Below, Celltelligence provides insights on the significance of this collaboration for Allogene’s clinical pipeline.

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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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CHMP Adopts Positive Opinion for Gilead’s Tecartus in r/r Mantle Cell Lymphoma

On Friday, October 16, Gilead announced (press release) that the CHMP has adopted a positive opinion for Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in ≥3L r/r mantle cell lymphoma (MCL). If approved by the EC, Tecartus would become the first and only CAR-T treatment approved for r/r MCL in Europe. Below, Celltelligence provides thoughts on Tecartus’s positive CHMP opinion and the likelihood of Gilead onboarding EU centers within 30 days of EC 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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Thoughts on Ide-cel Data Presentation at ASH 2020; FDA Unlikely to Hold an Ide-cel Advisory Committee Meeting; Summary of bluebird at Jefferies Cell Therapy Summit

On Tuesday, October 6, bluebird bio at the Jefferies Cell Therapy Virtual Summit (press release) highlighted upcoming clinical results for ide-cel at ASH 2020. Of note, bluebird discussed ide-cel’s projected approval timeline and the possibility of an FDA Advisory Committee Meeting. Furthermore, management outlined their position on ide-cel combinations with gamma-secretase inhibitors. Below, Celltelligence provides thoughts on ide-cel’s anticipated clinical update and bluebird’s possible messaging strategy for autologous CAR-Ts vs allogeneics.

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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 Wins Patent Challenge Relating to CAR-T Engineering

On Thursday, October 15, Precision BioSciences announced (press release) that the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) has ruled in favor of Precision. The ruling resulted from two patent interference proceedings that challenged nine U.S. patents owned by Precision. Below, Celltelligence provides brief thoughts on the patent win for Precision.

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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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JNJ-4528 US Filing Anticipated in Q4 2020; JNJ Q3 2020 Earnings Summary

On Tuesday, October 13, JNJ held their Q3 2020 earnings call (press release / presentation). Management reported a +13.3% WW sales growth for their oncology division, driven by their multiple myeloma product Darzalex (US +46%; WW +43.8%). Of note, JNJ confirmed that JNJ-4528 (BCMA CAR-T) is anticipated to be filed with the FDA in Q4 2020. Below, Celltelligence provides insights on a JNJ-4528 approval in 2021 and the potential impact on ide-cel (BMS) sales in the US and EU.

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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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Ziopharm´s RPM Allogeneic CD19 CAR-T Trial Started Enrollment; Q2 2020 Earnings Summary

On Thursday, August 6, Ziopharm held their Q2 2020 earnings call (press release / presentation), highlighting the initiation of their allogeneic CD19 CAR-T Ph1 trial post allo-SCT. Management confirmed that the IND submission in Greater China (China and Taiwan) for autologous CD19 CAR-Ts is anticipated by YE 2020. In Q1 2021, Ziopharm expects to submit CMC data for their personalized and library TCR-T IND application. Below, Celltelligence provides thoughts on Ziopharm’s global CD19 CAR-T initiatives and the potential challenges and opportunities for their TCR-T 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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Thoughts on Gilead’s sBLA Submission for Yescarta in r/r iNHL (ZUMA-5)

On Friday, September 4, Gilead announced (press release) the submission of an sBLA to the FDA for Yescarta in r/r ≥3L iNHL (follicular lymphoma and marginal zone lymphoma). The sBLA application is based upon positive results from the Ph2 ZUMA-5 trial. Below, Celltelligence provides insights on Yescarta’s sBLA timeline and the potential impact from competitors Novartis (Kymriah) and BMS (liso-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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Precision Biosciences Highlights First Patient Dosed with BCMA CAR-T PBCAR269A; PBCAR0191 Clinical Updates Delayed to YE; Q2 2020 Earnings Summary

On Thursday, August 13, Precision Biosciences released their Q2 2020 financial results (press release). While no new data was presented, Precision highlighted that the first patient was dosed with PBCAR269A (an allogeneic BCMA CAR-T) for the Ph1/2 trial in r/r MM. Moreover, management confirmed that interim data from the PBCAR0191 (an allogeneic CD19 CAR-T) Ph1 study in ≥3L r/r NHL and r/r ALL will be delayed due to the COVID-19 pandemic. Below, Celltelligence provides thoughts on key competitors Precision and Allogene’s position within the allogeneic BCMA CAR-T setting and the possibility for a PBCAR0191 presentation at ASH 2020.

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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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BMS and bluebird bio Receive Priority Review for Ide-cel; PDUFA Projected Around March 27, 2021

On Tuesday, September 22, BMS and bluebird bio announced (press release, BMS / press release, bluebird bio) that the FDA has granted a Priority Review for ide-cel (BCMA CAR-T) in ≥4L RRMM with a projected PDUFA date around March 27, 2021. Below, Celltelligence provides additional thoughts on ide-cel’s anticipated approval and the potential impact on BMS’s CVR milestone if the FDA requests additional information.

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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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Updated AUTO3 Ph1/2 ALEXANDER Results; ESMO 2020 Investor Call Summary

On Friday, September 18, Autolus held an investor call (press release / presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 ALEXANDER study in ≥3L DLBCL. The data was also presented at ESMO (E.Tholouli et al, Sep 2020). Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-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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