Category Archives: CAR-T

Ide-cel Approved by FDA as Abecma in r/r MM After Four Lines of Previous Therapy

Late yesterday evening, BMS and bluebird bio announced US approval of ide-cel after completing at least 4 lines of prior therapy in r/r MM (BMS press release). The press release states that Abecma is a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Of note, Abecma will be manufactured at BMS’s facility in Summit, New Jersey, with a median TAT of 33 days. The Celltelligence team will be conducting a full thoughts-on label review in the coming days (link to Abecma PI here).

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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 Approved in Japan; but What’s the Price?

On Monday, March 22, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Breyanzi (CD19 CAR-T) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), transformed low-grade NHL, and high-grade B-cell lymphoma (press release). Below, Celltelligence provides insights on Breyanzi’s market access in Japan, while commenting on Breyanzi’s potential pricing and manufacturing strategies compared to key competitors Kymriah (Novartis) and Yescarta (Gilead).

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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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Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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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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Gilead (Kite) Partners with COTA to Accelerate Clinical Development Using Real-World Data

On Tuesday, March 16, Gilead (Kite) announced a collaboration with COTA (press release), a real-world data (RWD) analytics company, to accelerate Gilead’s oncology CAR-T pipeline. Of note, COTA could provide valuable insights into clinical trial design and perhaps future therapeutic applications. Below, Celltelligence provides insights on how Gilead (Kite) could leverage COTA’s data to strategically accelerate promising clinical assets, as well as similar RWD partnerships for BMS, Novartis, and Tmunity.

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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 Autolus’s New Dual BCMA x CD19 CAR-T Ph1 Trial in Multiple Myeloma

On Friday, March 12, a new Autolus Ph1 trial named MCARTY was observed on CT.gov for a first-in-human study of a BCMA and BCMA x CD19 dual CAR-T in r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Autolus could differentiate themselves from competitors with BCMA CAR-T products closer to approval, while discussing engineering and dosing differences between BCMA x CD19 dual CAR-Ts from Autolus and Gracell.

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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 Kymriah’s Approval in Singapore; Could Singapore Become a Hub for Cell Therapy Medical Tourism in Southeast Asia?

On Tuesday, March 9, Novartis received approval (press release, PR Newswire, Mar 2021) for Kymriah (CD19 CAR-T) in pediatric r/r ALL and adult r/r DLBCL by Singapore’s Health Sciences Authority (HSA). Of note, Kymriah is now the first commercially approved CAR-T therapy in the region. Below, Celltelligence provides insights on how Novartis could leverage Kymriah’s approval in Singapore to expand within the Asia-Pacific market, Singapore’s pivot towards cell therapy manufacturing, and how BMS and Gilead compare in the region.

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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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No Major Updates Presented at Ziopharm’s R&D Day

On Thursday, March 11, Ziopharm held their R&D day (presentation) where they presented no major updates for their CD19 rapid manufacturing (RPM) CAR-T program or their personalized / library TCR-T approach. Nevertheless, management reiterated that their CD19 RPM cells could potentially cost $10,000, with a dose x100 lower than traditional autologous CAR-Ts. Finally, Ziopharm presented initial results from the CD19 RPM CAR-T investigator-initiated trials, highlighting the CAR-T’s acceptable tolerability profile (see image below).

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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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New Gilead KITE-222 (CLL-1 CAR-T) Ph1 Trial in R/R AML Posted

On Tuesday, March 9, a new Gilead (Kite) sponsored Ph1 trial was observed on CT.gov for a first-in-human study of KITE-222 (autologous CLL-1 CAR-T) in r/r acute myeloid leukemia (AML). Below, Celltelligence provides insights on the significance of Gilead expanding their pipeline into the AML setting and the potential competitors within the space.

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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 Receives Broader FL Label Than Breyanzi; MZL Not Granted in Yescarta’s ZUMA-5 Accelerated Approval

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated approvals and submissions following Gilead’s (Kite) announcement (see below for download).

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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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Cellectis Anticipates Submitting Multiple Undisclosed INDs Within 12 Months; No Clinical Updates for 3 UCART Programs; Cellectis Q4 2020 Earnings Call Summary

On Friday, March 5, Cellectis held their Q4 2020 earnings call (press release / no slides presented). Cellectis commented on their 3 ongoing clinical trials and the anticipated submission of multiple INDs for undisclosed CAR-T products within the next 12 months. Of note, management outlined their strategic approach to cell therapy development and licensing. Below, Celltelligence provides insights on Cellectis’s strategic approach to collaborations and manufacturing.

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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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