Tag Archives: Gilead

Autolus Confirms Obe-cel’s Ph1b/2 FELIX Trial Readout in 2022; Could Obe-cel be Approved by Early 2023? Yescarta Gains Reimbursement Approval in Australia and Gilead (Kite) Continues Expanding to Novel Cell Platforms with Appia Bio’s Collaboration; Autolus Q2 2021 Earnings Call Summary

On Thursday, August 5, Autolus held their Q2 2021 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) Ph1b/2 FELIX study in r/r ALL readout is on track for 2022. On the same day, Gilead (Kite) announced Yescarta’s (CD19 CAR-T) reimbursement approval in Australia (press release) and a collaboration with Appia Bio for the development of CAR invariant natural killer T (CAR-iNKT) cells for hematological malignancies (press release).

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New Gilead KITE-363 (CD19 x CD20 CAR-T) Ph1 Trial in R/R BCL Posted

On Wednesday, August 4, a new Gilead (Kite) Ph1 trial evaluating KITE-363 (autologous CD19 x CD20 CAR-T) in r/r B cell lymphoma (BCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing the significance of Gilead (Kite) developing a dual-targeting CAR-T.

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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 Consolidates Their Position as Market Leader; Could Tecartus in R/R Adult ALL Receive A Positive CHMP Opinion By YE 2021? Gilead’s Q2 2021 Earnings Call Summary

On Thursday, July 29, Gilead held their Q2 2021 earnings call (press release / presentation) highlighting an increase in overall revenue for their cell therapy franchise, while discussing the benefits of a potential FDA approval for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Furthermore, management highlighted the submission of a Type II variation to the EMA for Tecartus (CD19 CAR-T) in r/r adult ALL. Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s and Tecartus’s expansion into new indications to consolidate their position as a cell therapy market leader, while discussing likely EU approval timelines for Tecartus.

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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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BioNTech Acquires Kite’s TCR-T Platform and Manufacturing Facility; Is Kite Pivoting Away from TCR-Ts?

On Monday, July 19, Gilead (Kite) announced (press release) that BioNTech will acquire Kite’s individualized TCR platform and manufacturing facility in Gaithersburg, MD. Below, Celltelligence provides insights on Gilead’s (Kite) potential approach to treat solid tumors while discussing how BioNTech’s acquisition may quickly advance their pipeline by expanding their US manufacturing footprint.

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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’s Ph3 ZUMA-7 Trial Demonstrates Improved Efficacy of Yescarta vs SoC in 2L DLBCL; Which CD19 CAR-T Treating DLBCL Will Move Into an Earlier Line of Therapy First? First Patient Dosed With Precision’s PBCAR269A + Nirogacestat Combination

On Monday, June 28, Gilead (Kite) reported (press release) topline results from the primary analysis of Yescarta (CD19 CAR-T) vs the SoC in the Ph3 ZUMA-7 trial for 2L r/r DLBCL patients. Furthermore, Precision BioSciences and SpringWorks announced (press release) that the first patient has been dosed with PBCAR269A (BCMA CAR-T) + nirogacestat (GSI) in the Ph1/2a trial for r/r MM patients. Below, Celltelligence provides insights on how Yescarta’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Breyanzi (BMS) while discussing Precision’s and key competitor Allogene’s clinical progress combining a GSI with their lead BCMA CAR-T assets.

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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 / FKC876 Approved in China for Adult Patients With ≥3L R/R DLBCL

On Wednesday, June 23, Gilead announced (press release) that Yescarta (FKC876 / Yikeilen) has been approved by the Chinese NMPA for adult patients in ≥3L r/r DLBCL. Of note, Yescarta has become the first approved CAR-T in China. Below, Celltelligence provides insights on Yescarta’s Chinese regulatory history including which CAR-T could be approved next, while discussing the potential hurdles facing CAR-T reimbursement in China.

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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 Gilead’s Collaboration with Shoreline to Develop iPSC-derived Allogeneic Cell Therapies

On Thursday, June 17, Gilead (Kite) announced (press release) a strategic collaboration with Shoreline Biosciences to develop novel allogeneic cell therapies. Of note, the partnership will focus on the development of iPSC-derived CAR-NK therapies for hematological malignancies, with Gilead (Kite) having the possibility to include an iPSC-derived CAR-macrophage (CAR-M) program. Below, Celltelligence provides insights on Gilead’s (Kite) latest collaboration and the potential advantages CAR-NKs and CAR-Ms may have over CAR-T therapies.

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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 More Cost-Effective Compared to Kymriah but With Higher CRS and NT Rates; Updated Results From Kymriah’s Ph1b PORTIA Trial; POC CD19 CAR-Ts Outperform OOS Kymriah; EHA 2021 Day 1

On the first day of EHA 2021, seven key clinical updates were presented from Novartis, Gilead, the Sheba Medical Center, and the Fred Hutchinson Cancer Center. 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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Results from Kymriah’s Ph2 ELARA Trial; When Could Kymriah Become Approved in FL? Is Retreatment With Yescarta Commercially Feasible? CBMG Highlights Results From C-CAR066 and C-CAR039; ASCO 2021 Day 3 Part II

On the third day of ASCO 2021, five key clinical updates were presented from Novartis, Gilead, and CBMG. 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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New Gilead-Sponsored Post-Marketing Trial for Tecartus (ZUMA-2 Cohort 3) in R/R MCL

On Monday, May 10, a new post-marketing Tecartus Ph2 ZUMA-2 Cohort 3 trial in r/r MCL was observed on CT.gov. Below, Celltelligence provides insights on the study’s design and how Gilead could leverage this trial to gain a full FDA approval for Tecartus.

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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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