Category Archives: CAR-T

Thoughts on Abecma’s Positive CHMP Opinion for a Conditional Approval in ≥4L R/R MM

On Friday, June 25, BMS announced (press release) that the CHMP adopted a positive opinion for Abecma’s (idecabtagene vicleucel; BCMA CAR-T) conditional marketing authorization in ≥4L r/r multiple myeloma (MM). If approved by the EC, Abecma would become the first CAR-T treatment approved for r/r MM in Europe. Below, Celltelligence provides thoughts on Abecma’s positive CHMP opinion and its potential launch strategy within Europe, while comparing Abecma’s regulatory status between the EU and the UK.

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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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CHMP Adopts Positive Opinion for BMS’s Abecma in ≥4L r/r MM

On Friday, June 25, the CHMP adopted (press release) a positive opinion for Abecma (idecabtagene vicleucel; BCMA CAR-T) in ≥4L relapsed/refractory multiple myeloma (MM). The Celltelligence team will provide a detailed analysis in the coming days about Abecma’s positive CHMP opinion and BMS’s potential launch strategy within Europe.

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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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Yescarta / FKC876 Approved in China for Adult Patients With ≥3L R/R DLBCL

On Wednesday, June 23, Gilead announced (press release) that Yescarta (FKC876 / Yikeilen) has been approved by the Chinese NMPA for adult patients in ≥3L r/r DLBCL. Of note, Yescarta has become the first approved CAR-T in China. Below, Celltelligence provides insights on Yescarta’s Chinese regulatory history including which CAR-T could be approved next, while discussing the potential hurdles facing CAR-T reimbursement in China.

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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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JNJ / Legend Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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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Allogene Overland Appoints Shuyuan Yao as CEO

On Monday, June 21, Allogene announced (press release) that Shuyuan Yao has been appointed as CEO of Allogene Overland Biopharm. Below, Celltelligence provides insights on how Shuyuan Yao’s vast cell therapy experience could position Allogene Overland for rapid growth in Greater China and throughout the Asia-Pacific region.

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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 a Positive CHMP Opinion on June 24? BMS Seeks a Clock-Stop Extension for Breyanzi; CHMP Agenda June 2021

On Monday, June 21, the CHMP agenda for June was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed under the Opinions section, while the CHMP appears to require further information in relation to BMS’s clock-stop extension request for Breyanzi (BMS’s CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

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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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Will Abecma Receive a Positive CHMP Opinion by June 24? Breyanzi’s EU Regulatory Delay Continues; CAT Agenda June 2021

On Wednesday, June 16, the Committee for Advanced Therapies’s (CAT) agenda (June 16 – 18) was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed as ‘for opinion’ in June’s CAT agenda, while BMS has requested a clock-stop extension for Breyanzi (BMS; CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

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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 and Chinese IND in MM Planned for H1 2022: Could Gracell Leverage Data From Chinese Trials to Accelerate Their Clinical Programs in the US? Autolus’s Obe-cel Receives ILAP Designation in r/r Adult ALL

On Monday, June 14, Gracell held a clinical update conference call (webcast / presentation) discussing their regulatory strategy for GC012F (BCMA x CD19 CAR-T) and key company milestones. Additionally, on Tuesday, June 15, Autolus announced (press release) that the MHRA has granted obe-cel (AUTO1; CD19 CAR-T) an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) in r/r adult ALL. Below, Celltelligence provides insights on how Gracell could strategically accelerate development of key assets in the US, while highlighting Gracell’s next TruUCAR candidates. Furthermore, Celltelligence will comment on Autolus’s ILAP designation for obe-cel in r/r adult ALL.

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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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Yescarta Outperforms SoC in a Matched Analysis of ZUMA-5 in r/r FL; Tecartus’s Improved Safety Profile in the Ph1/2 ZUMA-4 Trial; Breyanzi’s Ph2 OUTREACH Trial Demonstrates the Feasibility of Outpatient Administration; Obe-cel Reports a Possible Best-in-Class Profile for Adult ALL; Mustang Bio’s MB-106 Reports a 93% ORR in NHL; EHA 2021 Day 3

On the last day of EHA 2021, five key clinical updates were presented from Gilead (Kite), BMS, Autolus, and Mustang Bio. Below, Celltelligence provides insights and context for each presentation.

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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 Demonstrates Improved Efficacy in Matched Analyses vs SoC; Cilta-cel’s New CARTITUDE-5 Trial in NDMM; Anakinra Prophylaxis Fails to Improve Orva-cel’s Safety Profile; Initial Clinical Data from Celyad’s CYAD-211 BCMA CAR-T; Gracell’s Investor Event: Will MRD Negativity Become a New Surrogate Marker? Updated Clinical Data from IASO’s CT103A; EHA 2021 Day 2

On the second day of EHA 2021, six key clinical updates were presented from JNJ / Legend, BMS, Celyad, Gracell, and IASO Biotherapeutics. Of note, Celyad and Gracell held two EHA-related investor events, while a new clinical trial for cilta-cel was observed on CT.gov. Below, Celltelligence provides insights and context for each presentation.

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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