Category Archives: CAR-T

Fate’s Novel FT573 Pan-Tumor Targeting Asset and Tri-Modal CAR-TCR Platform; Shoreline’s iPSC-derived Screening Platform; BMS’s Abecma to be Reimbursed in Japan on April 20; AACR 2022 Final Analysis

AACR 2022 Final Analysis: Several preclinical results were presented from Fate Tx, and Shoreline. Additionally, a cell therapy-related piece of news was observed, with Abecma set to become reimbursed in Japan after joining the NHI’s reimbursement price list on April 20, 2022. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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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Different Strategies for Enhancing CAR-Ts to Treat Solid Tumors; Preclinical Results from Allogene’s ALLO-316; TCR2 Tx’s Allogeneic TRuC-T Platform; AACR 2022 Analysis 4

AACR 2022 Analysis 4: Several key cell therapy-related topics were discussed to overcome the challenges associated with utilizing CAR-Ts for solid tumors. Additionally, preclinical results were presented from Allogene and TCR2 Tx. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

About The Author

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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Yescarta and Kymriah Product Attributes; Early Results from Gracell’s GC502 Ph1 Study in r/r B-ALL; Legend’s LB1901 Ph1 Study Design in r/r TCL; AACR 2022 Analysis 3

AACR 2022 Analysis 3: Several clinical updates were presented by Gilead, Novartis, Gracell, and Legend. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

About The Author

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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Preclinical Results from 2seventy’s bbT369 and Cellectis’s UCART20x22 for r/r NHL; Switchable CAR-T Updates from Arcellx and Roche; AACR 2022 Analysis 2

AACR 2022 Analysis 2: Several preclinical updates were presented describing two different dual-targeting strategies for r/r NHL and two approaches for developing switchable CAR-Ts. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

About The Author

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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How Engineered CAR-NK Cells Could Overcome Several Major Challenges Faced by CAR-Ts; Nkarta and CRISPR Tx Report Preclinical Data for Developing a CD70 CAR-NK and a NK:T Treatment; AACR 2022 Analysis 1

AACR 2022 Analysis 1: Several preclinical and clinical updates were presented describing potential strategies to overcome key hurdles associated with NK-based cell therapies. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

About The Author

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 Breyanzi’s sNDA Acceptance in Japan for 2L LBCL

BMS recently announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) accepted Breyanzi’s (CD19 CAR-T) sNDA in 2L LBCL. Below, Celltelligence provides insights on Breyanzi’s potential approval timeline for 2L LBCL in Japan, while discussing possible reimbursement issues as the CD19 CAR-T moves into earlier lines of therapy.

About The Author

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 Yescarta’s FDA Approval in 2L LBCL

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA has approved Yescarta (CD19 CAR-T) in 2L LBCL. Of note, Yescarta is now approved for adult patients with LBCL that are refractory or have relapsed within 12 months of 1L chemoimmunotherapy, independent of their eligibility for ASCT. Below, Celltelligence provides insights on how Yescarta could become the CAR-T of choice for 2L LBCL while discussing Gilead’s (Kite) potential strategy to increase patient referrals for Yescarta over ASCT.

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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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CHMP Adopts Positive Opinions for Kymriah and Carvykti; Tecartus Absent From March’s CHMP Highlights

On Friday, March 25, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Kymriah (Novartis’s CD19 CAR-T) in ≥3L r/r FL and a positive conditional marketing authorization for Carvykti (JNJ / Legend’s BCMA CAR-T) in ≥4L r/r MM. Additionally, Tecartus (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, the Celltelligence team provides thoughts on Kymriah’s and Carvykti’s positive opinion, while providing updated EU timelines for Tecartus.

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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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Breyanzi’s sNDA Accepted in Japan for 2L DLBCL

On Friday, March 25, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted Breyanzi’s (CD19 CAR-T) sNDA for 2L DLBCL. Of note, the acceptance is based on results from Breyanzi’s Ph3 TRANSFORM trial. The Celltelligence team will be conducting a full thoughts-on analysis and provide potential approval timelines in the coming days.

About The Author

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 Chinese CAR-T Ambitions after Lilly CRL and ODAC

On March 24, Lilly announced that the FDA has issued a CRL for Sintilimab + Pemetrexed and Platinum Chemotherapy in 1L non-squamous NSCLC. The CRL stated that the review cycle is complete, but the FDA is unable to approve the application in its current form, which is consistent with the outcome from February’s ODAC meeting which voted 14-1 against approving Lilly-Innovent’s PD-1 inhibitor (Lilly press release here). Recall that Lilly submitted an application to the FDA using only one pivotal trial conducted entirely in China. Despite the widespread lead-up and adcom media coverage, very little analysis or implications came through the lens of cell therapy, specifically CAR-T products. Since China is the #2 geography for conducting CAR-T clinical trials after the US, the Celltelligence team provides some hot takes on what the CRL outcome may mean for Chinese cell therapy companies with Western ambitions.

About The Author

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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