Category Archives: Autologous

Will a KarMMa Data Cut Help Abecma’s Successor Products? Safety and Efficacy Updates From bb21217’s Ph1 CRB-402 Study; Carvykti’s CARTITUDE-1 Continues Demonstrating Positive Clinical Results; ASH 2021 Day 2 Part 1

On the second day of ASH 2021, 3 clinical updates were presented by BMS, 2seventy, and Legend. Below, Celltelligence provides insights and context for each presentation.

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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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The Race to 2L DLBCL: Breyanzi’s Ph3 TRANSFORM Trial vs Yescarta’s Ph3 ZUMA-7 Study; Can BMS Shift Toward Outpatient CD19 CAR-T Administration? ASH 2021 Day 1 Part 2

On the first and second day of ASH 2021, 4 clinical updates were presented by BMS and Gilead (Kite) including Breyanzi’s (CD19 CAR-T) and Yescarta’s (CD19 CAR-T) efficacy and safety profiles in 2L DLBCL. Moreover, BMS commented on the feasibility of administering Breyanzi in the outpatient setting. Below, Celltelligence provides insights and context for each presentation.

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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 Autolus’s AUTO1/22 Novel CD22 Binder Avoid Antigen-Related Relapse in ALL? Updated Results from Cellectis’s UCART22 Ph1 BALLI-01 Trial; Yescarta’s Ph2 ZUMA-5 Trial Continues to Demonstrate Positive Long-Term Results; ASH 2021 Day 1 Part 1

On the first day of ASH 2021, 3 clinical updates were presented by Autolus, Cellectis, and Gilead. Below, Celltelligence provides insights and context for each presentation. In a subsequent blast, the Celltelligence team will provide insights from Precision’s PBCAR0191 (allogeneic CD19 CAR-T) clinical update and results from both Ph3 2L DLBCL studies from BMS (Breyanzi; CD19 CAR-T) and Gilead (Yescarta; CD19 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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Will Abecma Receive Approval in Japan by January 2022? Could JNJ / Legend’s Carvykti be Approved by September 2022?

On Monday, December 6, Japan’s Pharmaceutical Affairs and Food Sanitation Council (PAFSC) granted Abecma (BMS’s BCMA CAR-T) a positive opinion (press release, PharmaJapan, Dec 2021). Below, Celltelligence provides insights on Abecma’s potential approval and reimbursement timeline in Japan.

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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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JNJ / Legend Files Carvykti in Japan for R/R MM

On Monday, December 6, Legend announced (press release) that they have submitted Carvykti’s NDA (cilta-cel; BCMA CAR-T) to Japan’s Ministry of Health Labour and Welfare (MHLW) for the treatment of r/r MM. Below, Celltelligence provides insights on a likely approval timeline for Carvkyti 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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Novartis’s T-Charge Platform Reduces CAR-T Manufacturing to 2 Days; Novartis’s R&D Day Summary

On Thursday, December 2, Novartis held their R&D day (press release / presentation) highlighting T-Charge, a next-generation CAR-T manufacturing platform that reduces manufacturing time to ~2 days. Moreover, management discussed two novel assets YTB323 (CD19 CAR-T) and PHE885 (BCMA CAR-T) manufactured using the T-Charge platform. Below, Celltelligence provides insights on how Novartis could leverage T-Charge’s rapid manufacturing and potentially lower COGS to position their novel assets within the already crowded DLBCL and MM settings.

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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’s SC-DARIC33 IND Cleared by the FDA for R/R Pediatric AML; 2seventy Q3 2021 Earnings Summary

On Wednesday, December 1, 2seventy bio released their Q3 2021 financial results and operational updates (press release) highlighting their launch as an independent company. Moreover, management announced that the FDA has accepted an IND for SC-DARIC33’s (CD33 CAR-T) Ph1 PLAT-08 trial in r/r pediatric AML. Below, Celltelligence provides insights on 2seventy’s launch, while commenting on potential competitors for 2seventy’s SC-DARIC33 and bbT369 (CD20 x CD79a CAR-T) 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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Cilta-cel to be Commercialized as Carvykti Upon FDA Approval; JNJ Highlights Innovative Manufacturing and Supply System for Carvykti; How Quickly Could Carvykti Move Into Earlier Lines? JNJ’s Business Review Event 2021

On Thursday, November 18, JNJ held their Pharmaceutical Business Review 2021 Event (website) revealing cilta-cel’s (BCMA CAR-T) brand name as Carvykti, while commenting on their manufacturing and supply strategy to ensure a strong launch for Carvykti. Additionally, management emphasized their plan to quickly advance Carvykti into earlier lines of treatment. Below, Celltelligence provides insights on how JNJ’s manufacturing strategy may ensure a successful launch for Carvykti, while comparing JNJ’s digital platform with key competitors Gilead (Kite) and BMS. Moreover, Celltelligence will comment on the potential challenges JNJ may encounter advancing Carvykti into earlier lines for 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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When Could Legend File Cilta-cel in 2L MM? Legend to Submit an NDA to Japan’s PMDA for Cilta-cel in R/R MM by YE 2021; Legend Develops a Novel Tri-Specific CAR-T; Legend Q3 2021 Earnings Summary

On Tuesday, November 16, Legend released their Q3 2021 financial updates (press release) highlighting that enrollment for cilta-cel’s (BCMA CAR-T) Ph3 CARTITUDE-4 study in 2-4L r/r MM has completed, while discussing cilta-cel’s FDA and PMDA regulatory updates. Additionally, management announced the development of LCAR-AIO, a novel tri-specific CD19 x CD20 x CD22 CAR-T for treating B-cell malignancies following CAR-T therapy relapse. Below, Celltelligence provides insights on when Legend / JNJ could potentially file cilta-cel’s sBLA in 2L r/r MM based on data from CARTITUDE-4, while discussing Legend’s novel tri-specific CAR-T and pipeline updates.

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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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William Young Appointed as a Non-Executive Director of Autolus’s Board of Directors

On Monday, November 15, Autolus announced (press release) that William Young, Senior Advisor to Blackstone Life Sciences, has been appointed as a non-executive director to their Board of Directors, effective immediately. Of note, Young’s appointment follows Autolus’s recent collaboration with Blackstone. Below, Celltelligence provides insights on how Autolus could leverage Young’s operational experience to facilitate obe-cel’s (CD19 CAR-T, formerly AUTO1) launch.

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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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