Category Archives: Topics

Carvykti’s sBLA Application Submitted to the FDA after Outperforming the SOC on CARTITUDE-4 Trial in ≥2L MM; Longer-term Follow-up Data for CARTITUDE-1 and LEGEND-2 Trials; ASCO 2023 Analysis 4

ASCO 2023 Analysis 4: JNJ and Legend presented results for Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2-4L MM, which are the base of its sBLA submission to the FDA, announced by Legend on June 6, 2023 (press release). Additionally, 3-year and 5-year follow-up analyses for Carvykti’s Ph1b/2 CARTITUDE-1 and LEGEND-2 trials in ≥4L MM, respectively, were presented during ASCO 2023. Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC and the timeline of its potential FDA approval while discussing its curative potential for a wide range of MM patients.

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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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Adaptimmune Reports Interim OS Data from SPEARHEAD-1 trial; Automatically Manufactured BNT211 Corroborates Initial Promising Efficacy Results in Solid tumors; Promising Initial Clinical Results of CT0180 in HCC; ASCO 2023 Analysis 3

ASCO 2023 analysis 3: Adaptimmune, TCR2 Tx, BioNTech, and CARsgen Tx presented data on their cell therapy programs for solid tumors. 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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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:

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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Obe-cel Demonstrates Best-In-Class Safety Profile in R/R B-ALL; Autolus Presents Positive Ph2 Results; ASCO 2023 Analysis 1

ASCO 2023 Analysis 1: Autolus presented topline data from obe-cel’s (CD19 CAR-T) pivotal Ph1b/2 FELIX study in adult r/r B-ALL. The abstract was included in the ‘Hematologic malignancies – leukemia, myelodysplastic syndrome, and allotransplant’ oral abstract session which integrated three abstracts that covered the landscape of CAR-Ts in the ALL space followed by a scientific discussion. Below, Celltelligence provides insights and context for key selected presentations. 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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Adaptimmune and TCR2 Tx Complete Strategic Combination

On Thursday, June 1, Adaptimmune announced (press release) the completion of the strategic combination with TCR2 to form a preeminent cell therapy company to treat solid tumors. Moreover, the company hosted an event to elaborate on the newly established clinical milestones for all the assets in its pipeline (webcast / presentation) Below, Celltelligence provides insights on the approval of the merger by the companies’ shareholders, while discussing the future of its combined pipeline.

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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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Azer-cel’s Potential Ph2 Trial in CAR-T-Relapsed DLBCL Patients; Clinical Updates for Azer-cel and PBCAR19B; Precision’s Mid-Year 2023 Event

On Wednesday, May 31, Precision Biosciences held its mid-year 2023 pipeline update event (press release / presentation), highlighting plans to hold a meeting with the FDA to discuss a potential Ph2 trial evaluating azer-cel (allogeneic CD19 CAR-T) in DLBCL patients who relapsed after autologous CAR-T therapy. Additionally, management presented clinical updates for both allogeneic CD19 CAR-Ts (azer-cel and PBCAR19B). Below, Celltelligence provides insights on azer-cel’s improved safety profile due to the company’s manufacturing optimization process while discussing its potential to be a first-in-class allogeneic CAR-T for CD19+ CAR-T-relapsed patients.

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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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Carvykti’s Type II Variation Application Submitted to the EMA; Carvykti’s Submission to the FDA Planned; Could Carvykti be First Approved for ≥2L MM in Europe Ahead of the US?

On Thursday, May 25, Legend announced (press release) that a Type II Variation (T2V) application was submitted to the EMA for Carvykti’s (BCMA CAR-T) use in ≥2L MM patients. Below, Celltelligence provides insights on Carvykti’s regulatory timelines to gain a label extension for this setting in Europe, while discussing its to-date absent filing with the FDA.

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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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Encouraging Preclinical Data from ARI-0003, a New Academic Dual CAR-T for NHL; Can ARI-0003 Repeat the Success of ARI-0001? MiNK Tx Presented Preclinical Data of MiNK-215 in NSCLC; ASCGT 2023 Analysis 3

ASGCT 2023 Analysis 3: The Hospital Clinic of Barcelona presented preclinical data supporting the development of ARI-0003 (CD19 x BCMA CAR-T), its new academic cell therapy for the treatment of NHL patients. Moreover, MiNK Tx presented preclinical data of MiNK-215, the company’s FAP-targeting iNKT cell therapy. Bellow, Celltelligence provides insights and context for key selected presentations while discussing if ARI-0003 could replicate ARI-0001’s successful clinical development and point-of-care model.

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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No Cell Therapy-Related Updates in May’s CHMP Agenda; Abecma Likely to Be Included in June’s Agenda

On Monday, May 22, the CHMP Agenda for May was released. Of note, Abecma’s (BMS’s BCMA CAR-T) Type II Variation (T2V) for ≥3L MM was absent from the agenda, and no other cell therapy-related updates were observed. Therefore, based on the agenda, no updates are expected on the CHMP highlights to be published on Friday, May 26.

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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SC-DARIC33 Shows Promising Preliminary Clinical Results; 2seventy Bio Reveals Next-Generation AML Program; ASGCT 2023 Analysis 2

ASGCT 2023 Analysis 2: 2seventy bio presented preliminary clinical results of SC-DARIC33’s (autologous drug-regulated CD33 CAR-T) Ph1 PLAT-08 trial and several updates on preclinical assets at ASGCT. Moreover, on Friday, May 19, the company held a virtual R&D Deep Dive event further detailing the data presented at ASGCT 2023, disclosing the main features of its new AML asset 27T32 (next-generation autologous drug-regulated CD33 x CLL1 dual CAR-T) and confirming anticipated milestones for the rest of their pipeline assets (presentation). Below, Celltelligence provides insights on the potential advantage that drug-regulated activation could confer to SC-DARIC33 over other cell therapies in the AML space while commenting on the novel asset, 27T32, disclosed by the company.

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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