Category Archives: Topics

Yescarta’s Sales Grow; Gilead Prepares for Increased Manufacturing Demands; Tecartus’s EU Approval in R/R Adult ALL Faces Delays; Gilead’s Q4 2021 Earnings Call Summary

On Tuesday, February 1, Gilead held their Q4 2021 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise and Yescarta’s anticipated approval in 2L r/r LBCL. Furthermore, management highlighted Tecartus’s (CD19 CAR-T) Type II variation in the EU for r/r adult ALL. Below, Celltelligence provides insights on how Gilead’s manufacturing strategy could position the company for success, while discussing likely US and EU approvals for Yescarta in 2L LBCL.

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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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FDA Approves an Updated Label for Yescarta to Include Prophylactic Corticosteroids Use

On Monday, January 31, Gilead (Kite) announced (press release) that the FDA has approved Yescarta’s (CD19 CAR-T) updated prescribing information to include the use of prophylactic corticosteroids across all approved indications. Of note, the label update is based on results from Cohort 6 of the Ph1/2 ZUMA-1 trial in r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s updated US label, while discussing how it could facilitate Yescarta’s administration in the outpatient 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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CHMP Adopts Positive Opinion for BMS’s Breyanzi in ≥3L R/R DLBCL

On Friday, January 28, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted (press release) a positive opinion for Breyanzi’s (liso-cel; BMS’s CD19 CAR-T) marketing authorization in ≥3L r/r DLBCL, PMBCL, and FL grade 3B. Below, Celltelligence provides thoughts on Breyanzi’s positive CHMP opinion, while comparing Breyanzi’s regulatory EU timeline with other commercialized CAR-Ts.

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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 Appoints Cintia Piccina as Chief Commercial Officer

On Wednesday, January 26, Adaptimmune announced (press release) the appointment of Cintia Piccina as Chief Commercial Officer (CCO), effective January 31, 2022. Below, Celltelligence provides insights on how Piccina’s experience may position afami-cel (MAGE-A4 SPEAR-T; formerly ADP-A2M4) for a successful commercial launch.

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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 FDA Approval Anticipated Around February 28, 2022; JNJ Q4 2021 Earnings Call Summary

On Tuesday, January 25, JNJ held their Q4 and FY 2021 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T; cilta-cel) anticipated FDA approval around February 28, 2022. Below, Celltelligence provides insights on how JNJ may leverage Carvykti’s best-in-class profile to quickly gain market share following launch.

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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 Positive CHMP Opinion This Week? Tecartus Continues to Experience Delays; January’s CHMP Agenda

On Monday, January 24, the CHMP agenda for January was released. Of note, Breyanzi (BMS’s CD19 CAR-T) is listed under the ‘Opinions’ section. No other key cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Breyanzi, while discussing regulatory timelines for Kymriah and Yescarta in r/r FL, Tecartus in r/r adult ALL, and Carvykti in r/r 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 Approved in Japan; Can BMS Meet the Increased Manufacturing Demand? Novartis and Pack Health Explore Digital Coaching to Improve Quality of Life Outcomes Following CAR-T Treatment

On Thursday, January 20, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Abecma (BCMA CAR-T) for the treatment of ≥4L r/r MM. Moreover, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with Novartis and Ohio State University Comprehensive Cancer Center appearing as collaborators. Below, Celltelligence provides insights on Abecma’s potential market access in Japan, while commenting on how the current viral vector shortage could limit BMS’s ability to deliver Abecma in 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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GSK Appoints Tony Wood as CSO

On Wednesday, January 19, GSK announced (press release) the appointment of Tony Wood as Chief Scientific Officer (CSO), effective August 1, 2022. Of note, Hal Barron will step down as GSK’s CSO and become a Non-Executive Director of the Board, with additional responsibilities to support R&D. Furthermore, Barron will become CEO and Board Co-Chair of Altos Labs effective August 1, 2022. Below, Celltelligence provides insights on how Wood’s appointment may impact GSK’s development of innovative therapies.

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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JPM 2022 Day 3 & 4: Precision and TCR2 Tx

On the third and fourth (final) day of JPM 2022, Celltelligence covered presentations by Precision BioSciences (presentation) and TCR2 Tx (press release / corporate presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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 to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been observed:

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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