Tag Archives: GC012F

Gracell’s GC012F US IND Submission Delayed to H2 2022; Assets Targeting Solid Tumors to Enter the Clinic in 2022; Gracell Expands Operations in the US; Gracell Q4 2021 Earnings Call Summary

On Monday, March 14, Gracell held their Q4 2021 earnings call (press release / presentation) highlighting GC012F’s delayed US IND filing while confirming multiple clinical updates for both TruUCAR and SMART CAR platforms in 2022. Furthermore, management confirmed the opening of their first R&D site in the US. Below, Celltelligence provides insights on possible reasons why GC012F’s IND submission may have been delayed, while discussing Gracell’s potential pipeline reprioritization.

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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.

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 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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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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