Tag Archives: Gracell

Rapid CAR-T Manufacturing Platforms Show Promise in R/R MM; Novartis and Gracell Present New Ph1 Data for PHE885 and GC012F; ASCO 2023 Analysis 2

ASCO 2023 Analysis 2: Novartis and Gracell presented clinical updates on CAR-T assets in r/r MM developed using next-generation platforms designed to reduce manufacturing time. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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GC012F Results in MM and NHL to Be Presented at ASCO and EHA; New GC012F Trial in SLE; GC007g Demonstrates Remarkable Ph1 IIT Results in ALL; Gracell’s Q1 2023 Earnings Call Summary

On Monday, May 15, Gracell held its Q1 2023 earnings call (press release) highlighting the presentation of results from GC012F (BCMA x CD19 FasTCAR-T) and GC007g (allogeneic CD19 CAR-T) in several hematological indications at ASCO and EHA 2023, while disclosing the initiation of a Ph1 IIT evaluating GC012F in refractory systemic lupus erythematosus (SLE). Below, Celltelligence provides insights on the interest of Gracell in establishing a collaboration for the development of the GC012F’s Ph1b/2 trial for ≥4L MM to be initiated in the US, while comparing GC012F to its main competitors in the SLE field.

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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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Abecma’s sBLA Filing in ≥3L MM Remains on Track for Q1 2023; No Pipeline Updates; 2seventy bio Q4 2022 Earnings Summary; Gracell Acquires Patent Licenses from Seagen

On Thursday, March 16, 2seventy bio released its Q4 and FY 2022 financial results (press release) highlighting Abecma’s (BCMA CAR-T) increased US revenue. Additionally, management did not provide major milestone updates for 2023, with Abecma’s sBLA filing to the FDA for ≥3L MM still expected in Q1 2023. On the same day, Gracell reported (SEC Filing) a license agreement with Seagen, under which Gracell will have WW licenses to certain patents for clinical and preclinical research, as well as commercialization, of cell therapy products. Below, Celltelligence provides insights on Abecma’s potential market growth for 2023, while discussing the license agreement between Gracell and Seagen.

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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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GC012F’s Ph1/2 Trials in the US and China to Initiate in 2023; Will FasTCAR-Ts be as Fast as Initially Thought? Gracell’s Q4 2022 Earnings Call Summary

On Monday, March 13, Gracell held their Q4 and FY 2022 earnings call (press release / presentation) highlighting the upcoming initiation of GC012F’s (autologous BCMA x CD19 FasTCAR-T) Ph1/2 trials for r/r MM in the US and China. Additionally, management reported clinical updates for GC007g (allogeneic CD19 CAR-T) and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on Gracell’s potential partnership for advancing the clinical development of GC012F in the US, while discussing if fast manufacturing platforms will ultimately be able to differentiate themselves from traditional autologous CAR-Ts.

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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 Reports Strong Cell Therapy Revenues; ZUMA-23 Delayed? New Galapagos Asset Added to the Pipeline; Gilead’s Q4 2022 Earnings Call Summary; Gracell Reports FDA IND Clearance for GC012F in R/R MM

On Thursday, February 2, Gilead (Kite) held its Q4 and FY 2022 earnings call (press release / presentation) highlighting WW FY 2022 cell therapy revenue of $1.5B, while noting a potential delay in the initiation of Yescarta’s (CD19 CAR-T) Ph3 ZUMA-23 trial for 1L HR LBCL. Moreover, Gilead included a new cell therapy asset in its pipeline and confirmed that Arcellx’s collaboration for CART-ddBCMA has been completed. On Friday, February 3, Gracell announced (press release) that the FDA cleared GC012F’s (autologous CD19xBCMA FastCAR-T) IND application for a Ph1b/2 trial in r/r MM. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing Gracell’s major regulatory milestone.

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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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BMS, Gracell, CARsgen, and Fate Tx Report Clinical Results from Next-Generation Assets in MM; ASH 2022 Analysis 4

ASH 2022 Analysis 4: BMS, Gracell, CARsgen and Fate Tx presented clinical updates from their novel cell therapies in r/r MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered 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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Gracell to Submit GC012F’s IND for R/R MM in the US and China; GC012F Demonstrates 100% ORR in NDMM; Clinical Progress from GC007g, GC503, and GC506; Gracell’s Q3 2022 Earnings Call Summary

On Monday, November 14, Gracell held their Q3 2022 earnings call (press release / presentation), highlighting results from GC012F’s (autologous BCMAxCD19 FasTCAR-T) Ph1/2 IIT in NDMM, and planned IND submissions in the US and China for r/r MM. Additionally, management provided clinical updates for GC007g (allogeneic CD19 CAR-T), GC503 (mesothelin SMART CAR-T), and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on GC012F’s potential as a first-line treatment in MM, while discussing a possible partnership strategy in the US.

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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 IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL patients.

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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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Gracell Appoints Wendy Li as Chief Medical Officer

On Monday, August 1, Gracell announced (press release) the appointment of Wendy Li as Chief Medical Officer (CMO). Below, Celltelligence provides insights on how Gracell could leverage Li’s vast experience in the CAR-T field.

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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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Gracell Appoints Samuel Zhang as Chief Business Officer

On Tuesday, July 19, Gracell announced (press release) the appointment of Samuel Zhang as Chief Business Officer (CBO). Below, Celltelligence provides insights on how Gracell could leverage Zhang’s vast biopharma experience.

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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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