Category Archives: Topics

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:

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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 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.

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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 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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Yescarta Becomes the First Approved CAR-T for 2L LBCL in the US

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA approved Yescarta (CD19 CAR-T) in 2L LBCL based on results from the Ph3 ZUMA-7 trial. Of note, Yescarta has become the first CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.   

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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.

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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 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.

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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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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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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 Extends Its Cash Runway Into 2025; Could Abecma Receive a ≥3L MM Approval Between 2023 – 2024? 2seventy Q4 2021 Earnings Summary

On Tuesday, March 22, 2seventy bio released their Q4 2021 results (press release) highlighting their extended cash runway into 2025 and Abecma’s (BCMA CAR-T) potential FDA approval in ≥3L MM between 2023 – 2024. Of note, no major updates were provided for other pipeline assets. Below, Celltelligence provides insights on how 2seventy could leverage their extended cash runway, while comparing Abecma’s potential approval in ≥3L MM with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).

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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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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.

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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