Category Archives: Autologous

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 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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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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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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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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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.

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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 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

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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 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

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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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Afami-cel’s BLA Filing Anticipated During Q4 2022; MAGE-A4 Allogeneic Platform On Track for IND Submission in 2023; No Major Updates for Precision BioSciences; Adaptimmune and Precision Q4 2021 Earnings Summaries

On Monday, March 14, Adaptimmune held their Q4 2021 earnings call (press release / webcast) highlighting afami-cel’s (autologous MAGE-A4 SPEAR-T; formerly ADP-A2M4) anticipated BLA filing in Q4 2022, while discussing anticipated milestones for their MAGE-A4 franchise. On Tuesday, March 15, Precision BioSciences reported their Q4 2021 financial results (press release), however, no major clinical or regulatory updates were provided. Below, Celltelligence provides insights on potential approval timelines for afami-cel.

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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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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

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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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