Tag Archives: BCMA

Thoughts on Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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Carvykti’s Revenue Remains Flat; CARTITUDE-4 Readout Expected in 2023; JNJ Q4 2022 Earnings Call Summary

On Tuesday, January 24, JNJ held their Q4 and FY 2022 earnings call (press release / presentation) confirming that a data readout from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial for 2 – 4L MM is expected in 2023. On the same day, Legend disclosed (SEC filing, Jan 2023) that Carvykti’s preliminary WW sales for Q4 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s flat revenue, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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 Revenue Increases +20% QoQ Driven by ex-US Sales; KarMMa-2 Results to be Presented at ASH 2022; NEX-T Programs Deprioritized; BMS Q3 2022 Earnings Call Summary

On Wednesday, October 26, BMS held its Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management provided clinical updates for Abecma and noted the discontinuation of their NEX-T CAR-T programs. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact of BMS’s clinical updates in its strategy.

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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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Carvykti’s Revenue Increases to $55M; JNJ Expects Franchise to Generate $5B by 2025; Will Carvykti be Approved in 2L MM by Q3 2023? JNJ Q3 2022 Earnings Call Summary

On Tuesday, October 18, JNJ held their Q3 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) potential to generate $5B by 2025. Additionally, management confirmed that a data readout from Carvykti’s Ph3 CARTITUDE-4 trial in 2-4L MM is expected by YE 2022. On the same day, Legend disclosed (SEC filing, Oct 2022) that Carvykti’s preliminary WW sales for Q3 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s revenue increase, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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’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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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.

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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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Thoughts on Poseida’s Strategic Global Collaboration with Roche

On Wednesday, August 3, Poseida announced (press release / presentation) a strategic global collaboration with Roche to develop and commercialize existing and novel allogeneic cell therapies for hematologic indications. Of note, Poseida will receive $110M upfront and further milestone payments potentially exceeding $6B in aggregate value. Below, Celltelligence provides insights on Roche’s shift in interest regarding cell therapies, while discussing Poseida’s partnering strategy.

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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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Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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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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Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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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Legend Achieves Two Major Milestone Payments for Carvykti

On Friday, February 11, Legend announced that they have achieved two milestones under their collaboration with JNJ for the development of Carvykti (cilta-cel; BCMA CAR-T), resulting in an aggregate payment of $50M to Legend. Below, Celltelligence guesses which milestones the payments could be related to.

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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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