Category Archives: CAR-T

TCR2 Tx Submits Gavo-cel’s Protocol Amendment to the FDA; TC-510’s IND Filed in Q1 2022; TCR2 Tx Q4 2021 Earnings Release

On Tuesday, March 22, TCR2 Tx reported their Q4 2021 results (press release) highlighting gavo-cel’s (TC-210; autologous mesothelin TRuC-T) protocol amendment and TC-510’s (gavo-cel + PD-1 x CD28 switch; autologous mesothelin TRuC-T) IND filing to the FDA. Furthermore, management provided preclinical updates for TC-520 (CD70 TRuC-T + IL-15 enhancement) and their allogeneic program. Below, Celltelligence provides insights on how TCR2 Tx could reprioritize their mesothelin TRuC-T franchise while discussing the company’s allogeneic program.  

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Could Carvykti Receive a CHMP Positive Opinion This Week? Type II Variations for Tecartus and Kymriah Listed in March’s CHMP Agenda

On Monday, March 21, the CHMP agenda for March was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) has been listed under ‘Initial applications; Opinions’. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) and Kymriah (Novartis’s CD19 CAR-T) have been listed under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for r/r adult B-ALL and r/r FL, respectively. Below, Celltelligence provides insights on the potential EU approval timeline for Carvykti in r/r MM.

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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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Legend Continues to Expand the CARTITUDE Program; Will Carvykti Receive Approval in Japan by September 2022? Legend Receives Official FDA Clinical Hold Letter for LB1901; Legend Q4 2021 Earnings Summary

On Friday, March 18, Legend released their Q4 2021 results (press release) highlighting Carvykti’s (cilta-cel; BCMA CAR-T) recent FDA approval in ≥5L r/r MM and several clinical program updates. Additionally, management confirmed that they received an official FDA clinical hold letter for LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on Legend’s LCM initiatives for Carvykti, while discussing LB1901’s FDA clinical hold.

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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 Carvykti’s Label, Price, Manufacturing, and TAT Compared to Abecma

On Monday, February 28, 2022, JNJ / Legend announced (JNJ press release / Legend press release) that the FDA approved Carvykti (cilta-cel; autologous BCMA CAR-T) for the treatment of r/r MM after ≥4 prior lines of therapy based on results from the Ph1b/2 CARTITUDE-1 trial. Below, Celltelligence provides insights on Carvykti’s reported higher manufacturing failure rate compared with Abecma, while discussing Carvykti’s potential messaging strategy.

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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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Gracell’s GC012F US IND Submission Delayed to H2 2022; Assets Targeting Solid Tumors to Enter the Clinic in 2022; Gracell Expands Operations in the US; Gracell Q4 2021 Earnings Call Summary

On Monday, March 14, Gracell held their Q4 2021 earnings call (press release / presentation) highlighting GC012F’s delayed US IND filing while confirming multiple clinical updates for both TruUCAR and SMART CAR platforms in 2022. Furthermore, management confirmed the opening of their first R&D site in the US. Below, Celltelligence provides insights on possible reasons why GC012F’s IND submission may have been delayed, while discussing Gracell’s potential pipeline reprioritization.

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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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Poseida’s Upcoming Clinical Updates for 2022; Poseida Seeks Further Partners to Develop Their Novel Platforms; Poseida Q4 2021 Earnings Summary

On Thursday, March 10, Poseida released their Q4 2021 results (press release) highlighting their anticipated clinical updates for 2022, while expressing their interest in partnering their emerging technologies. Below, Celltelligence provides insights on Poseida’s potential strategy to prioritize allogeneic PSMA therapies while discussing their possible partnering strategy for their emerging technologies.

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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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Obe-cel’s US Filing Delayed to H2 2023; Stevenage Manufacturing Site to be Operational by Mid-2023; Autolus Q4 2021 Earnings Call Summary

On Thursday, March 10, Autolus held their Q4 2021 earnings call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) regulatory delays, while confirming multiple clinical updates at EHA 2022. Furthermore, Autolus provided further manufacturing and executive updates. Below, Celltelligence provides insights on how Autolus may try to offset obe-cel’s delayed potential US approval, while discussing Autolus’s manufacturing strategy and AUTO1/22’s market opportunity.

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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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Carvykti Approved by FDA in R/R MM After Four Lines of Previous Therapy

Following JNJ’s press release, Celltelligence has updated Carvykti’s FDA approval for r/r MM patients having received at least 4 lines of prior therapy. 

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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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Yescarta Absent From February’s CHMP Highlights

On Friday, February 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Yescarta’s absence from the CHMP highlights, while providing updated EU 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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Poseida’s P-PSMA-101 Demonstrates Encouraging Efficacy in mCRPC; Upcoming Milestones for Poseida’s Allogeneic Platform; Poseida Seeking to Partner Their Emerging Technologies; Poseida’s R&D Day Summary

On Wednesday, February 23, Poseida Therapeutics held an R&D day (press release / presentation) highlighting the potential of their non-viral piggyBac gene delivery system for generating novel cell therapies. Moreover, management noted anticipated milestones for their allogeneic CAR-T platform. Below, Celltelligence provides insights on how Poseida’s allogeneic improvements could significantly decrease manufacturing costs, while discussing Poseida’s development of CAR-T therapies from different cell sources.

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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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