Category Archives: Topics

Thoughts on Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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 Meets Primary Endpoint in Pivotal Trial for R/R CLL

On Thursday, January 26, BMS announced (press release) that Breyanzi (CD19 CAR-T) has met its primary endpoint (CR) in the Ph1/2 TRANSCEND CLL 004 trial for patients with ≥3L CLL / SLL. Below, Celltelligence provides insights on Breyanzi’s market opportunity for CLL, while discussing potential approval timelines in the US.

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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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Carvykti’s CARTITUDE-4 Met its Primary Endpoint in r/r MM

On Friday, January 27, Legend Biotech announced (press release) that Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM met its primary endpoint (PFS), demonstrating a statistically significant improvement compared to the SOC (PVd or DPd). The Celltelligence team will be conducting an in-depth analysis 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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Breyanzi 2L LBCL Absent from Third Consecutive Meeting; January’s CHMP Highlights

On Friday, January 27, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from January’s CHMP meeting. Below, Celltelligence provides updated EU timelines for Breyanzi, including commentary on the consecutive CHMPs where Breyanzi has been absent.

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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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Carvykti’s Revenue Remains Flat; CARTITUDE-4 Readout Expected in 2023; JNJ Q4 2022 Earnings Call Summary

On Tuesday, January 24, JNJ held their Q4 and FY 2022 earnings call (press release / presentation) confirming that a data readout from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial for 2 – 4L MM is expected in 2023. On the same day, Legend disclosed (SEC filing, Jan 2023) that Carvykti’s preliminary WW sales for Q4 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s flat revenue, while discussing potential US regulatory timelines for Carvykti in 2L 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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Breyanzi Absent from January’s CHMP Agenda

On Monday, January 23, the CHMP agenda for January was released. Of note, Breyanzi’s (BMS’s CD19 CAR-T) Type II Variation for 2L LBCL transplant-intended patients was absent from the agenda, and no other cell therapy-related updates were observed. On Friday, January 27, when the CHMP highlights are released, the Celltelligence team will provide updated timelines for Breyanzi’s potential EU approval.

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 AstraZeneca’s Cell Therapy Pipeline

On Monday, January 16, AstraZeneca (AZ) announced (press release) the completion of Neogene Therapeutics’ acquisition for developing TCR-T therapies in solid tumors. Moreover, during JPM 2023, AZ introduced (presentation) AZD5851 (GPC3 armored CAR-T), its first official cell therapy program. Below, Celltelligence provides insights on AstraZeneca’s increasing interest in cell therapies, while discussing the potential of its innovative cell therapy pipeline.

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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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JPM 2023 Analysis Day 4: Autolus and Caribou Biosciences

On the fourth and final day of JPM 2023, Celltelligence covered presentations from Autolus (webcast / presentation) and Caribou Biosciences (webcast / presentation). 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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JPM 2023 Analysis Day 3: Century Tx, Atara Bio, and Precigen

On the third day of the JPM 2023, Celltelligence covered presentations by Century Tx (press release / webcast / presentation), Atara Bio (webcast / presentation), and Precigen (press release / presentation). 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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Precision BioSciences and 2seventy bio Provide Business Updates for 2023; JPM 2023 Analysis Day 2: Allogene and GSK

A series of cell therapy-related news items have been observed:

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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