Category Archives: Topics

Updated Guidance for Lete-cel; GSK / Haleon Business Separation Completed; GSK’s Q2 2022 Earnings Call Summary

On Wednesday, July 27, GSK held their Q2 2022 earnings call (presentation / press release) providing updated guidance for their lead cell therapy asset lete-cel (NY-ESO-1 TCR-T) and confirming the successful separation of the consumer healthcare business (Haleon). Below, Celltelligence provides insights on lete-cel’s potential approval while comparing with key competitor afami-cel (Adaptimmune’s MAGE-A4 SPEAR-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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CHMP Adopts Positive Opinion for Tecartus; Yescarta Absent From July’s CHMP Highlights

On Friday, July 22, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Tecartus (Gilead / Kite’s CD19 CAR-T) in r/r adult B-ALL. Additionally, Yescarta (Gilead / Kite’s CD19 CAR-T) was absent from the CHMP highlights. Below, Celltelligence provides thoughts on Tecartus’s positive opinion, while discussing updated EU timelines for Yescarta.

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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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UPDATE: Legend Discloses Carvykti’s Q2 2022 Revenue of $24M

On Thursday, July 21, Legend Biotech reported (6-K SEC) that Carvykti (JNJ / Legend’s BCMA CAR-T) generated approximately $24M in “net trade sales” in Q2 2022. Of note, during JNJ’s Q2 2022 earnings call, management highlighted that the first Carvykti sales had been recorded, but did not disclose its Q2 2022 revenue (see previous insight). The Celltelligence team will analyze how Carvykti’s revenue compares with key competitor Abecma (BMS’s BCMA CAR-T) after BMS releases its Q2 2022 financial results on July 27, 2022.

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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Are Cell Therapy Leaders Losing Their Innovative Edge? Final Analysis

In our previous six-part series, the Celltelligence team discussed the pipeline, manufacturing technology, novel platforms, and potential strategy to maintain an innovative clinical program for Novartis, BMS, and Gilead (Kite):

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Gilead (Blast 6/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1-2 and 3-4, the Celltelligence team discussed Novartis’s and BMS’s pipeline, manufacturing technology, novel platforms, and potential strategy for maintaining an innovative clinical program:

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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Kymriah’s Sales Remain Flat After US and EU Approvals in ≥3L FL, PHE885’s Submission Delayed to 2025; YTB323’s Development Strategy Being Updated; Novartis Q2 2022 Earnings Call Summary

On Tuesday, July 19, 2022, Novartis held their Q2 2022 earnings call (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) approval in ≥3L FL, both in the US and EU. Additionally, PHE885’s (T-Charge BCMA CAR-T) submission has been delayed to 2025, while YTB323’s (T-Charge CD19 CAR-T) Ph3 trial development strategy is under review. Below, Celltelligence provides insights on Novartis’s potential strategies to increase Kymriah’s revenue, while discussing if the company could use their recently acquired Priority Review Voucher to accelerate their T-Charge programs.

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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Gracell Appoints Samuel Zhang as Chief Business Officer

On Tuesday, July 19, Gracell announced (press release) the appointment of Samuel Zhang as Chief Business Officer (CBO). Below, Celltelligence provides insights on how Gracell could leverage Zhang’s vast biopharma experience.

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 Carvykti Revenue Disclosed; JNJ Q2 2022 Earnings Call Summary

On Tuesday, July 19, JNJ held their Q2 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) US launch in April 2022, and subsequent EC conditional approval for ≥4L MM in May 2022. Below, Celltelligence provides insights on Carvykti’s potential US and EU launch strategy, while comparing it with key competitor Abecma (BMS’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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Gilead (Blast 5/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1-2 and 3-4, the Celltelligence team discussed Novartis’s and BMS’s pipeline, manufacturing technology, novel platforms, and potential strategy for maintaining an innovative clinical program:

About The Author

The Celltelligence Team

|
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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Type II Variations for Yescarta and Tecartus Listed in July’s CHMP Agenda

On Monday, July 18, the CHMP agenda for July was released. Of note, Yescarta and Tecartus (Gilead / Kite’s autologous CD19 CAR-Ts) have been listed as ‘For adoption’ under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section for 2L LBCL and r/r adult B-ALL, respectively.

About The Author

The Celltelligence Team

|
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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