Tag Archives: LEADING COMPANIES

Kymriah Sales Decrease; Prioritization of CAR-T Therapies for Immunology over LBCL and MM; Novartis Strategy for Contract Manufacturing; Novartis’s Q1 2023 Earnings Call Summary

On Tuesday, April 25, Novartis held their Q1 2023 earnings call (press release / presentation) reporting $135M in Kymriah’s (CD19 CAR-T) WW sales. Of note, the company disclosed the prioritization of CAR-T programs in immunology over LBCL and MM indications. Below, Celltelligence provides insights on Kymriah’s Q1 2023 revenue, while discussing YTB323’s (T-Charge CD19 CAR-T) potential in the immunologic space and Novartis’s contract manufacturing strategy.

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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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No Cell Therapy-Related Updates in April’s CHMP Agenda

On Monday, April 24, the CHMP Agenda for April was released. Of note, no cell therapy-related updates were observed. Recall that Abecma’s (BMS’s BCMA CAR-T) indication extension to ≥3L MM patients could potentially be included in May’s CHMP agenda (see previous insight).

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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 CARTITUDE-4’s EHA Abstract Being Prematurely Posted; Carvykti Demonstrates an Impressive Efficacy Profile in 2-4L MM

On Tuesday, April 18, Carvykti’s (JNJ / Legend’s BCMA CAR-T) topline results of its Ph3 CARTITUDE-4 trial were reported after its abstract was unintentionally posted on EHA’s website. The results suggest a superior efficacy profile of Carvykti over SOC therapy (news, Endpoints News, Apr 2023). Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC while discussing its potential to become the new SOC therapy in the 2L MM setting.

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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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UPDATED: Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Requirements; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary

UPDATED: On April 3, 2023, Celltelligence published a blast entitled “Carvykti’s CARTITUDE-6 Trial to Initiate Ex-US Due to FDA Safety Concerns; LB2102 IND Clearance in SCLC; Legend H2 2022 Earnings Call Summary”. Since then, Janssen reached out to Celltelligence to clarify that FDA’s safety “concern” is really more about meeting a “requirement” for re-filing the IND than anything else. The team has updated the April 3 blast to reflect the clarity provided by Janssen.

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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 Revenue Increases +31% QoQ; Novartis to Manufacture Carvykti; JNJ Q1 2023 Earnings Call Summary

(Celltelligence is aware of the CARTITUDE-4 abstract leak and will have a thoughts-on analysis after the team returns from AACR.)

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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 Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan

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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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CHMP Adopts Positive Opinion for Breyanzi in 2L LBCL; When Could Abecma Receive a CHMP Positive Opinion for ≥3L MM? March CHMP Highlights

On Friday, March 31, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted a positive opinion for Breyanzi (BMS’s CD19 CAR-T) in 2L LBCL. Below, Celltelligence provides insights on the March CHMP meeting with updated EU timelines for Breyanzi’s approval and Abecma’s (BMS’s BCMA CAR-T) regulatory pathway to gain an indication in ≥3L 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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Could Breyanzi Receive a CHMP Positive Opinion This Week? Abecma Starts EMA Assessment in ≥3L MM; March’s CHMP Agenda

On Monday, March 27, the CHMP agenda for March was released. Of note, Breyanzi (BMS’s CD19 CAR-T) was listed for the third time under the ‘Type II Variations – Opinion or Requests for Supplementary Information’ section in 2L DLBCL Transplant Intended (TI) patients. Additionally, Abecma (BMS’s BCMA CAR-T) was also listed as ‘Start of Procedure’ under ‘Type II Variations: Extension of Indications’ for ≥3L MM 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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Francesco Marincola Departs Kite as Head of Cell Therapy Research; Yescarta Significantly Improved OS in 2L LBCL

On Tuesday, March 21, Sonata Therapeutics announced (press release) the CSO appointment of Francesco Marincola, former SVP and Global Head of Cell Therapy Research at Gilead (Kite). On the same day, Gilead (Kite) reported (press release) the primary overall survival (OS) data analysis of Yescarta’s (autologous CD19 CAR-T) Ph3 ZUMA-7 trial in 2L DLBCL demonstrating a significant OS improvement for Yescarta versus SOC. Below, Celltelligence provides insights on Marincola’s departure from Kite, while discussing how OS data could further support Yescarta’s leading position in the 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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Breyanzi Absent from February’s CHMP Highlights

On Friday, February 24, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, Breyanzi (BMS’s CD19 CAR-T) was absent from the CHMP highlights implying that it has received a second RSI for its assessment in 2L LBCL. Below, Celltelligence provides updated EU approval timelines for Breyanzi.

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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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