Category Archives: Uncategorized

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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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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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.

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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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Ph1 TSCAN-001 Trial Shows Encouraging Preliminary Results; TScan to Initiate Trial in Solid Tumors in 2023; 8 IND Submissions Expected by YE 2024; Kelonia Presents Promising In Vivo CAR-T Preclinical Results; ASCGT 2023 Analysis 1

ASGCT 2023 Analysis 1: Tscan presented preliminary clinical data of the Ph1 TSCAN-001 trial while Kelonia presented preclinical results of its innovative in vivo CAR-T platform. Moreover, on May 17, TScan held a virtual ASGCT meeting further detailing their initial clinical results. 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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Why Kite’s New Leader Makes Strategic Sense for Gilead; Allogene’s CMO Pursues Other Opportunities

On May 16, Gilead (Kite) announced the appointment of Cindy Perettie as EVP of Kite (press release), overseeing the cell therapy business. Moreover, on May 18, Replay Bio announced (press release) the appointment of Allogene’s former CMO, Arun Balakumaran, as the company’s new CMO. Below, Celltelligence provides insights on how Perettie’s healthcare experience and background could benefit Gilead’s pursuit of bringing cell therapy to solid tumors.

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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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Adaptimmune and TCR2 Tx to Discuss Merger at the End of May; Completion of Afami-cel’s rolling BLA Submission Remains on Track; Adaptimmune’s and TCR2 Tx’s Q1 2023 Earnings Call Summary

On Friday, May 12, Adaptimmune held its Q1 2023 earnings call (press release) highlighting that the company will host a General Meeting on May 30 to evaluate the merger with TCR2 Tx while confirming that afami-cel’s (autologous MAGE-A4 SPEAR-T) rolling BLA submission is expected to be completed in mid-2023. Similarly, TCR2 Tx confirmed a special stockholder meeting to endorse the deal with Adaptimmune on the same day (press release). Below, Celltelligence provides insights on the importance of the approval of the merger for both companies, while discussing Adaptimmune’s anticipated plans for its MAGE-A4 assets.

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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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Cellectis to Deprioritize its Multiple Myeloma Program; All Ongoing Trials to Include Sanofi’s Alemtuzumab as Lymphodepleting Agent; Cellectis’s Q1 2023 Earnings Call Summary

On Friday, May 5, Cellectis held its Q1 2023 earnings call (press release) highlighting the company’s decision to deprioritize the clinical development of UCARTCS1 (allogeneic CS1 CAR-T) in multiple myeloma to focus on the advancement of the rest of its pipeline. Below, Celltelligence provides insight on Cellectis’s decision to stop investing in its MM program, while discussing the implementation of Sanofi’s alemtuzumab (anti-CD52 mAb) across all its trials.

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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