Category Archives: Autologous

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 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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Could Yescarta Receive a CHMP Positive Opinion for ≥4L FL This Week? Yescarta’s Evaluation for 2L DLBCL Listed in February’s CHMP Agenda

On Monday, February 21, the CHMP agenda for February was released. Of note, Yescarta’s (Gilead /Kite’s CD19 CAR-T) Type II Variations in ≥4L FL and 2L DLBCL are listed under ‘Type II Variations – Opinions or Requests for Supplementary Information’. No other cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Yescarta in ≥4L FL.

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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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BMS Receives Priority Review for Breyanzi in 2L LBCL; Breyanzi’s PDUFA Date Set for June 24, 2022

On Thursday, February 17, BMS announced (press release) that the FDA has granted a Priority Review for Breyanzi (CD19 CAR-T) in 2L LBCL, with a PDUFA date of June 24, 2022. Below, Celltelligence provides additional thoughts on how Breyanzi’s anticipated US approval in the 2L setting compares with Yescarta (Gilead / Kite; CD19 CAR-T).

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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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Legend’s CD4 CAR-T Trial in TCL is Placed on Clinical Hold by the FDA

On Tuesday, February 15, Legend announced (press release) that the FDA has placed a clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on plausible causes of the clinical hold and how competitors may achieve a better safety profile.

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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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2seventy Appoints Steven Bernstein as Their New CMO; Susan Abu-Absi Appointed as 2seventy’s Chief Technology and Manufacturing Officer

On Monday, February 14, 2seventy bio announced (press release) the appointment of Steven Bernstein as Chief Medical Officer (CMO) and Susan Abu-Absi as Chief Technology and Manufacturing Officer. Below, Celltelligence provides insights on how 2seventy could leverage Bernstein’s translational clinical background to bring novel assets into the clinic, while discussing the company’s decision to create a Chief Technology and Manufacturing Officer position. 

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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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Legend Achieves Two Major Milestone Payments for Carvykti

On Friday, February 11, Legend announced that they have achieved two milestones under their collaboration with JNJ for the development of Carvykti (cilta-cel; BCMA CAR-T), resulting in an aggregate payment of $50M to Legend. Below, Celltelligence guesses which milestones the payments could be related to.

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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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