Category Archives: Topics

The EC Grants Tecartus Marketing Authorization for R/R Adult ALL

On Tuesday, September 6, Gilead (Kite) announced (press release) that the European Commission (EC) granted Marketing Authorization for Tecartus (CD19 CAR-T) in r/r adult (≥26 years) B-ALL. Below, Celltelligence provides insights on Tecartus’s approval in the EU, while comparing it with ARI-0001 (academic CD19 CAR-T) and obe-cel (Autolus’s CD19 CAR-T).

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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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New Abecma KarMMa-9 Trial for Newly Diagnosed MM Patients

On Wednesday, September 7, 2seventy bio announced (press release) plans to initiate the KarMMa-9 study evaluating Abecma (BMS / 2seventy’s BCMA CAR-T) in newly diagnosed MM patients who have suboptimal response to transplant. The Celltelligence team will conduct an in-depth analysis of the KarMMa-9 trial as more details are released on CT.gov.

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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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Precision Appoints Cindy Atwell as CBO and Jeff Smith as CRO; Derek Jantz to Act as CEO’s Partner

On Friday, September 2, Precision BioSciences announced (press release) several senior leadership organizational changes. Below, Celltelligence provides insights on Precision’s latest additions to their leadership team.

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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 / Kite Expands Cell Therapy Operations in Brazil, Singapore, and Saudi Arabia

On Wednesday, August 31, Gilead (Kite) announced the expansion of their cell therapy operations to Brazil, Singapore, and Saudi Arabia (press release). Below, Celltelligence provides insights on how Yescarta (Kite’s CD19 CAR-T) could quickly challenge Kymriah’s (Novartis’s CD19 CAR-T) market exclusivity in these geographies, while discussing Kite’s potential manufacturing expansion strategy.

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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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Thoughts on Kymriah’s ≥3L r/r FL Approval in Japan; Could Kymriah’s Price Decrease? Novartis’s APAC Market Expansion Strategy

On Friday, August 26, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Kymriah (Novartis’s CD19 CAR-T) for the treatment of r/r FL (press release). Below, Celltelligence provides insights on Kymriah’s potential pricing reduction in Japan, while discussing Novartis’s cell therapy expansion in the APAC market.

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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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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 August’s CHMP Agenda

On Tuesday, August 16, the CHMP agenda for August was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that for the CHMP meetings from June and July 2022, the Celltelligence team prepared two full analyses providing the following EC approval timelines for Breyanzi (BMS’s CD19 CAR-T) and Yescarta (Gilead / Kite’s CD19 CAR-T):

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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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P-PSMA-101 Clinical Program Delayed; Poseida’s Global Collaboration with Roche; Poseida Q2 2022 Earnings Summary

On Thursday, August 11, 2022, Poseida released their Q2 2022 results (press release) highlighting anticipated clinical updates for H2 2022 and the recent partnership with Roche. Below, Celltelligence provides insights on a potential delay for Poseida’s P-PSMA-101 (autologous PSMA CAR-T) program, while discussing Poseida’s partnering strategy.

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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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Abecma’s Ph3 KarMMa-3 Trial Meets Primary Endpoint; Potential Delays for bbT369 and SC-DARIC33; 2seventy bio Q2 2022 Earnings Call Summary

On Wednesday, August 10, 2seventy bio held their Q2 2022 earnings call (press release) highlighting positive topline results from Abecma’s (autologous BCMA CAR-T) Ph3 KarMMA-3 trial in ≥3L MM. Additionally, management provided updated data readouts for bbT369 (autologous CD20xCD79a dual CAR-T) and SC-DARIC33 (autologous CD33 CAR-T). Below, Celltelligence provides insights on Abecma’s LCM initiatives, while discussing potential clinical delays for bbT369 and SC-DARIC33.

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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BMS Reports Positive Topline Results From Abecma’s Ph3 KarMMa-3 Trial for ≥3L MM vs SoC: Will Abecma be the First Approved CAR-T in ≥3L MM?

On Wednesday, August 10, BMS and 2seventy bio reported positive topline results from Abecma’s (BCMA CAR-T) Ph3 KarMMa-3 trial in ≥3L MM (press release). Below, Celltelligence provides insights on how Abecma’s potential approval timeline in ≥3L MM compares with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).

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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