Category Archives: Dual/triple agonist

Gracell’s GC012F Receives IND Clearance in Early Line MM

On Monday, January 29, Gracell announced (press release) that the FDA cleared the IND application to start a Ph1 trial to evaluate GC012F (BCMA x CD19 FasTCAR-T) in early line MM. Below, Celltelligence provides insights on Gracell’s major regulatory milestone, while discussing the importance of this trial for AstraZeneca’s cell therapy franchise.

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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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JPM 2024 Analysis Day 1: BMS, Gilead, Novartis, and JNJ

On the first day of JPM 2024, Celltelligence covered presentations by BMS (presentation / webcast), Gilead (presentation / webcast), Novartis (presentation / webcast), and JNJ (webcast). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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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BMS-986393 Continues Showing Impressive ORR in ≥4L MM but Durability Fails to Impress; Initial Promising Results from AUTO8 in r/r MM; ASH 2023 Analysis 1

ASH 2023 Analysis 1: BMS and Autolus presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Autolus Submits Obe-cel BLA in R/R B-ALL; GC012F Receives IND Clearance in rSLE

On Monday, November 27, Autolus announced (press release) the submission of a BLA to the FDA for the use of obe-cel (CD19 CAR-T) in adult r/r B-ALL, supported by data from the Ph1/2 FELIX trial.

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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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GC012F’s US Trial in MM Initiates Dosing; GC012F IND in SLE on Track for 2023; Gracell Initiates GC506 Clinical Development in Solid Tumors and Deprioritizes GC007g in B-ALL; Gracell’s Q3 2023 Earnings Call Summary

On Monday, November 13, Gracell held its Q3 2023 earnings call (press release) highlighting the initiation of dosing in the Ph1b/2 trial evaluating GC012F (BCMA x CD19 FasTCAR-T) for ≥4L MM in the US, while confirming that the IND submissions for the evaluation of GC012F in refractory SLE (rSLE) in the US and China remain on track for 2023. Additionally, the company disclosed the initiation of GC506 (CLDN18.2 SMART CAR-T) clinical development in solid tumors and the discontinuation of GC007g (allogeneic CD19 CAR-T) in B-ALL. Below, Celltelligence provides insights on GC012F potential in MM and rSLE while discussing possible causes of GC007g discontinuation and the initiation of the clinical evaluation of a CLL-1 x CD38 dual CAR-T in AML.

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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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AstraZeneca and Cellectis Enter into Collaboration to Develop up to 10 Novel Cell and Gene Therapy Candidates Leveraging Cellectis’s Gene Editing Technologies and Manufacturing Capabilities

On Wednesday, November 1, AstraZeneca (press release) and Cellectis (press release) announced they entered into a strategic collaboration and investment agreement for the development of up to 10 novel cell and gene therapy candidate products in areas of high unmet need, including oncology, immunology, and rare diseases. Below, Celltelligence provides insights on the partnership, analyzes Cellectis’s TALEN-based gene-editing platform, and discusses how both companies could benefit from the collaboration.

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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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An ARI-0003 Trial to Be Initiated by Hospital Clinic; Mustang’s MB-109 Receives IND Clearance from the FDA

On Tuesday, October 24, a new early Ph1 CARTD-BG-1 trial evaluating ARI-0003 (BCMA x CD19 CAR-T), an academic CAR-T developed by the Hospital Clinic of Barcelona, Spain, in r/r B-cell aggressive lymphoma was posted on CT.gov. Moreover, on Thursday, October 26, Mustang Bio announced FDA acceptance of the IND application to evaluate MB-109 [MB‐101 (IL13Rα2 CAR-T) + MB-108 (HSV1 oncolytic virus)] in recurrent glioblastoma (GBM) and high-grade astrocytoma (press release). Below, Celltelligence provides insights on both cell therapies, discussing their potential advantages.

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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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CB-012’s IND Cleared by the FDA; Caribou Joins the AML Race

On Wednesday, October 18, Caribou announced CB-012’s (allogeneic CLL-1 CAR-T; PD-1 KO + B2M KO + TCR KO + B2M-HLA-E KI) IND clearance by the FDA to start a trial in 2-4L AML. Below, Celltelligence provides insights on the trial design while discussing the potential advantages of Caribou’s AML program over its competitors.

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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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Gilead to Initiate Trial to Evaluate New KITE-197 Asset in LBCL; AstraZeneca to Start Clinical Development of AZD5851 in HCC patients

On October 12, a new Gilead (Kite)-sponsored Ph1 trial investigating KITE-197, a novel asset with an undisclosed target, in r/r LBCL patients was posted on CT.gov. Additionally, on October 16, a new AZ-sponsored Ph1/2 ATHENA trial evaluating AZD5851 (TGFβRIIDN armored GPC3 CAR-T) in ≥2L GPC3 positive advanced / recurrent HCC was detected. Below, Celltelligence discusses the potential targets of KITE-197 while evaluating the relevance of the new AZ-sponsored clinical trial and the competitive advantage of AZD5851 over other GPC3 CAR-Ts.

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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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You May Have Missed: CARsgen Partners with Moderna; AZ to Collaborate in the Development of a New CAR-T in Solid Tumors; Gilead to Evaluate Novel Dual CAR-T; Poseida and Roche Publish P-CD19CD20-ALLO1’s New Trial; Germany’s G-BA Completes Carvykti’s Reimbursement – August 2023 Recap (Blast 1/2)

In August 2023, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. Celltelligence will publish a two-part series discussing the news and providing insights about their importance in the cell therapy space. In this first summary, the following topics are covered:

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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