Category Archives: Topics

Amtagvi Becomes the First Approved T-Cell Therapy in Solid Tumors

On Friday, February 16, Iovance Biotherapeutics announced (press release) that the FDA granted accelerated approval to Amtagvi (lifileucel), a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy to treat adult patients with unresectable or metastatic melanoma after anti-PD1 and targeted therapy. Below, Celltelligence provides insights on the importance of Amtagvi’s approval in the solid tumors field, while discussing Iovance’s plans and pipeline.

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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 Positive Opinion in Q1 2024? February CHMP Agenda

On Monday, February 19, the CHMP agenda for February was released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was included in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥2L MM.

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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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Autolus and BioNTech Enter into Strategic Alliance

On Thursday, February 8, Autolus and BioNtech announced (press release) a strategic CAR-T cell therapy collaboration to advance their pipelines and expand their late-stage programs. Below, Celltelligence provides insights on the partnership and how Autolus and BioNTech could benefit from it.

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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 Revenue Decreases while Tecartus Sales Hold; ZUMA-24 Readout Delayed to H2 2024; Anito-cel’s Trial in Early Line MM to Initiate in H2 2024; Gilead’s Q4 2023 Earnings Call Summary

On Tuesday, February 6, Gilead held its Q4 2023 earnings call (press release / presentation) highlighting that the Yescarta (CD19 CAR-T) sales decreased Q0Q while Tecartus (CD19 CAR-T) revenue showed a slight increase. Additionally, the company delayed the readout from Yescarta’s Ph2 ZUMA-24 to H2 2024, with results from anito-cel’s (formerly CART-ddBCMA; BCMA CAR-T) Ph2 iMMagine-1 trial also anticipated in the second part of the year. Finally, Gilead disclosed that the enrollment of the first patient in anito-cel’s Ph3 trial in early-line MM is expected in H2 2024.

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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 Regeneron Acquiring 2seventy bio’s Pipeline; How Could Regeneron Leverage its New Cell Therapy Pipeline?

On Tuesday, January 30, Regeneron announced (press release) the formation of Regeneron Cell Medicines based on an asset purchase agreement to acquire full development and commercialization rights to 2seventy bio’s pipeline, along with the clinical manufacturing capabilities, and related platform technologies.

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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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Abecma and Breyanzi Revenues Increase; BMS-986353 to be Evaluated in MS; BMS’s Q4 2023 Earnings Call Summary

On Friday, February 2, BMS held its Q4 2023 earnings call (press release / presentation) highlighting the increase in global sales of Abecma (BMS / 2seventy bio’s BCMA CAR-T) and Breyanzi (CD19 CAR-T) while reporting plans to evaluate its BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in multiple sclerosis (MS).

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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 bio to Focus Exclusively on Abecma; Sells Pipeline to Regeneron; Afami-Cel BLA Granted Priority Review

On Tuesday, January 30, 2seventy bio announced (press release) a new strategic path focusing exclusively on the commercialization and development of Abecma (BCMA CAR-T). In connection with this, and as shared (press release) by Regeneron, the company has entered into an asset purchase agreement with Regeneron to sell its oncology and autoimmune R&D programs, clinical manufacturing capabilities, and related platform technologies.

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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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Kymriah Sales Continue to Decline; No Updates on Cell Therapy Programs; Novartis’s Q4 2023 Earnings Call Summary

On Wednesday, January 31, Novartis held its Q4 2023 earnings call (press release / presentation) reporting $120M in Kymriah (CD19 CAR-T) WW sales, while the company did not provide any update on its cell therapy programs.

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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 Regulatory Applications for R/R FL and R/R MCL Accepted in the US and Japan

On Tuesday, January 30, BMS announced (press release) that the Breyanzi (CD19 CAR-T) sBLAs for r/r FL and r/r MCL have been accepted by the FDA with projected PDUFA dates on May 23, 2024, and May 31, 2024, respectively. Additionally, the application for Breyanzi in r/r FL has also been validated in Japan.

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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 Receives IND Clearance in Early Line MM

On Monday, January 29, Gracell announced (press release) that the FDA cleared the IND application to start a Ph1 trial to evaluate GC012F (BCMA x CD19 FasTCAR-T) in early line MM. Below, Celltelligence provides insights on Gracell’s major regulatory milestone, while discussing the importance of this trial for AstraZeneca’s cell therapy franchise.

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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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