Tag Archives: Gilead

GILD: Q1 2021 Earnings Call Summary; JNJ: Cilta-cel MAA Submitted

On Thursday, April 29, Gilead held their Q1 2021 earnings call (press release / presentation), highlighting the rapid recovery of their cell therapy sales revenue, while discontinuing several Yescarta and Tecartus programs. Furthermore, on Friday, April 30, JNJ announced (press release) cilta-cel’s (BCMA CAR-T) MAA submission to the EMA for r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s European expansion to recover and grow market share, while discussing cilta-cel’s potential EU approval timelines.

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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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Humanigen Cancels Collaboration with Gilead (Kite) to Test Lenzilumab with Other Commercial CD19 CAR-Ts; FDA Accepts Allogene’s TurboCAR ALLO-605 (BCMA CAR-T) IND; First Patient Dosed with Ziopharm’s RPM CD19 CAR-T in Taiwan; No Regulatory Updates for Cilta-cel in JNJ’s Q1 2021 Earnings Call

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

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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 Reports Innovative Biomarkers Associated with Clinical Outcomes in the Ph2 ZUMA-5 Trial; Carl June Explores Novel Approaches to Improve CAR-T Function; IL-2 Makes a Comeback with OrthoCARs; AACR 2021 Day 3

On the third day of AACR 2021 Week I, key clinical / preclinical updates were reported from Gilead (Kite) and Synthekine, while Carl June presented an overview of CAR-T engineering tools to improve efficacy and safety outcomes. Below, Celltelligence provides insights and context for each presentation.

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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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Novel In-depth Product Characteristics for Kymriah and Yescarta Correlate with Patient Outcomes; Gracell’s Clinical Update for GC027 TruUCAR in T-ALL; Preliminary Results for TCR2’s Gavo-cel in Mesothelin Overexpressing Solid Tumors; AACR 2021 Day 1

On the first day of AACR Week I 2021, four key clinical updates were presented from Novartis, Gilead (Kite), Gracell, and TCR2 Therapeutics. Below, Celltelligence provides insights and context for each presentation.

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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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Gilead Files Tecartus’s sBLA in Adult R/R ALL; AUTO1 Receives PRIME Designation by the EMA; JNJ / Legend Complete Cilta-cel’s Rolling BLA in the US; BMS Files Abecma in Japan for R/R MM; Precision’s New CEO Transition Plan

Ahead of AACR, a series of cell therapy-related news items have been observed:

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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) Partners with COTA to Accelerate Clinical Development Using Real-World Data

On Tuesday, March 16, Gilead (Kite) announced a collaboration with COTA (press release), a real-world data (RWD) analytics company, to accelerate Gilead’s oncology CAR-T pipeline. Of note, COTA could provide valuable insights into clinical trial design and perhaps future therapeutic applications. Below, Celltelligence provides insights on how Gilead (Kite) could leverage COTA’s data to strategically accelerate promising clinical assets, as well as similar RWD partnerships for BMS, Novartis, and Tmunity.

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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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Yescarta’s Median Time to CRS Improved by Prophylactic Corticosteroid Use; Thoughts on Frank Neumann Joining Kite as Worldwide Head of Clinical Development

On Wednesday, February 10, Gilead (Kite) announced (press release / abstract) updated results from cohort 6 of the Ph1/2 ZUMA-1 trial. The analysis showed that prophylactic use of corticosteroids has the potential to delay Yescarta’s CRS onset. Additionally, Gilead announced (press release) that Frank Neumann has joined Kite as Senior Vice President and Global Head of Clinical Development. Below, Celltelligence provides insights on how Yescarta’s improved safety profile could bring CRS onset parity with Breyanzi and if Kite’s recent senior management appointments could suggest a reprioritization towards solid tumors.

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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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Yescarta’s Q4 2020 Sales Decline and Kymriah Takes a QoQ Sales Lead for the First Time; Gilead Q4 2020 Earnings Call Summary

On Thursday, February 4, Gilead (Kite) held their Q4 2020 earnings (press release / presentation). Management highlighted the overall increase in revenue for their cell therapy franchise. However, Yescarta’s WW QoQ sales decreased as a result of weak US sales. Below, Celltelligence provides insights on the potential causes for Yescarta’s reduced US revenue and how Gilead may recover market share in the short- to mid-term.

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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Yescarta Approved in Japan; Early Reimbursement Likely by March; UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated approvals and submissions following presentations from JPM 2021 (see below for download).

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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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FDA Accepts Precision’s PBCAR19B IND in R/R NHL; Francesco Marincola Joins Kite as Worldwide Head of Cell Therapy Research

On Tuesday, January 19, Precision BioSciences announced (press release) that the FDA has accepted the IND for PBCAR19B (an allogeneic CD19 CAR-T) in ≥3L r/r NHL. Additionally, Gilead announced (press release) that on February 1, 2021, Francesco Marincola will join Kite as Senior Vice President and Global Head of Cell Therapy Research. Below, Celltelligence provides insights into PBCAR19B’s dosing and anticipated clinical milestones, with thoughts on how Francesco Marincola’s vast healthcare experience could drive cell therapy innovation at Gilead (Kite).

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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