Category Archives: Topics

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 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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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 Gilead’s Collaboration with Shoreline to Develop iPSC-derived Allogeneic Cell Therapies

On Thursday, June 17, Gilead (Kite) announced (press release) a strategic collaboration with Shoreline Biosciences to develop novel allogeneic cell therapies. Of note, the partnership will focus on the development of iPSC-derived CAR-NK therapies for hematological malignancies, with Gilead (Kite) having the possibility to include an iPSC-derived CAR-macrophage (CAR-M) program. Below, Celltelligence provides insights on Gilead’s (Kite) latest collaboration and the potential advantages CAR-NKs and CAR-Ms may have over CAR-T therapies.

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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 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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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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Yescarta More Cost-Effective Compared to Kymriah but With Higher CRS and NT Rates; Updated Results From Kymriah’s Ph1b PORTIA Trial; POC CD19 CAR-Ts Outperform OOS Kymriah; EHA 2021 Day 1

On the first day of EHA 2021, seven key clinical updates were presented from Novartis, Gilead, the Sheba Medical Center, and the Fred Hutchinson Cancer Center. 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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BMS Reports Positive Topline Results From Breyanzi’s Ph3 TRANSFORM Trial in 2L DLBCL vs SoC: Will Breyanzi be the First Approved CAR-T in 2L DLBCL?

On Thursday, June 10, BMS reported positive topline results from Breyanzi’s (CD19 CAR-T) Ph3 TRANSFORM trial in 2L DLBCL (press release). Below, Celltelligence provides insights on how Breyanzi’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Yescarta (Gilead / Kite).

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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Cilta-cel Continues to Demonstrate Best-in-Class Efficacy With an Improved Safety Profile; Abecma’s Efficacy in Hard-to-Treat Subgroups; Could Gracell’s FasTCAR GC012F (BCMA x CD19) Further Decrease TATs? Thoughts on Arcellx’s Initial Results From CART-ddBCMA; ASCO 2021 Day 4

On the final day of ASCO 2021, eight key clinical updates were presented from JNJ / Legend, BMS, Gracell, and Arcellx. 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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