Category Archives: CAR-T

Gilead Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L setting.

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Precision Appoints Michael Amoroso as Their New CEO

On Monday, September 27, Precision BioSciences announced (press release) the appointment of Michael Amoroso as the company’s President, Chief Executive Officer (CEO), and member of the Board of Directors, all effective October 15, 2021. Below, Celltelligence provides insights on how Amoroso could lead Precision through their next phase of growth.

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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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Two Novel CAR-Ts for Solid Tumors Demonstrate Promising Efficacy / Activity; Are CAR-Ts More Advantageous Than Bispecific Antibodies? ESMO 2021 Day 4 – 6

On the last three days of ESMO 2021, two key presentations highlighting clinical and pre-clinical data for CAR-T candidates treating solid tumors were presented. Additionally, a Controversy Session was held discussing the key benefits and challenges for bispecific antibodies and CAR-Ts.

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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 Appoints Jae Park to Their Scientific Advisory Board

On Monday, September 20, Allogene announced (press release) that Jae Park has been appointed to their Scientific Advisory Board (SAB). Below, Celltelligence provides insights on how Allogene could leverage Park’s clinical experience to advance novel pipeline products.

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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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GSK Explores Better Patient Selection Methods for Lete-cel; Could 2seventy bio Nominate Medigene’s PRAME TCR-T as Their Second Target? Adaptimmune Presents Preclinical Data from ADP-A2M4CD8; No Updated Preclinical Results from Carisma; Tecartus Absent from CHMP Highlights; ESMO 2021 Day 1&2

On the first two days of ESMO 2021, four key pre-clinical and clinical presentations from GSK, Medigene, Adaptimmune, and Carisma were presented. On Friday, September 17, the CHMP highlights for September were released. Of note, no updates from Tecartus’s Type II variation for r/r adult ALL were observed. Below, Celltelligence provides insights and context for each presentation, while providing likely EU approval timelines for Tecartus.

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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 Announces Progress with New UK Manufacturing Site

On Thursday, September 16, Autolus announced (press release) planning approval for a new manufacturing facility in Stevenage, UK. Of note, the manufacturing facility will initially provide ~2,000 doses a year of obe-cel (CD19 CAR-T; formerly AUTO1). Below, Celltelligence provides insights into Autolus’s manufacturing strategy, while discussing whether the new facility could enhance Autolus’s potential to be acquired.

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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 John Johnson to Their Board of Directors

On Wednesday, September 15, Autolus announced (press release) John Johnson’s appointment as non-executive chairman of their Board of Directors. Additionally, Martin Murphy, who previously served as chairman, will continue to serve as a non-executive board member. Below, Celltelligence provides insights on Autolus’s leadership strategy to prepare for obe-cel’s (CD19 CAR-T, formerly AUTO1) commercial launch, while commenting on the potential acquisition of Autolus.

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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 Novartis’s Ph3 BELINDA Trial Failure; Will Novartis Continue Pursuing Kymriah in the 2L DLBCL Setting?

Recently, Novartis reported (press release) that their Ph3 BELINDA study evaluating Kymriah (CD19 CAR-T) in 2L NHL did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis’s trial design could have potentially contributed to BELINDA’s failure, while discussing alternative approaches that Novartis may take to stay in the 2L DLBCL setting.

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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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Adaptimmune’s ADP-A2M4CD8 Has a Best Response With Ovarian Cancer Patients; Legend’s LB1901 Ph1 Trial Initiated in the US

On Monday, September 13, Adaptimmune reported (press release / presentation) updated data from ADP-A2M4CD8’s (MAGE-A4 SPEAR-T) Ph1 SURPASS study for multiple solid tumors. Of note, Adaptimmune highlighted ADP-A2M4CD8’s safety profile and compared initial efficacy data to the company’s first-generation MAGE-A4 SPEAR-T therapy (afami-cel; formerly ADP-A2M4). On the same day, Legend announced (press release) the start of LB1901’s (CD4 CAR-T) Ph1 trial in the US for r/r peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Below, Celltelligence provides insights on which indications Adaptimmune could prioritize, while discussing Legend’s clinical development of LB1901 in the TCL setting.

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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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Will Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus 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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