Tag Archives: CD19

Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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 Oncology Deep Dive 2022: Celltelligence Analysis – Part 1

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event, highlighting their differentiated pipeline, with key updates to their cell therapy platforms, including several new clinical trials (Presentation). Below, Celltelligence provides insights on Gilead / Kite’s expansion of Yescarta and Tecartus (CD19 CAR-Ts) into earlier lines of therapy / additional indications.

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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 Yescarta’s FDA Approval in 2L LBCL

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA has approved Yescarta (CD19 CAR-T) in 2L LBCL. Of note, Yescarta is now approved for adult patients with LBCL that are refractory or have relapsed within 12 months of 1L chemoimmunotherapy, independent of their eligibility for ASCT. Below, Celltelligence provides insights on how Yescarta could become the CAR-T of choice for 2L LBCL while discussing Gilead’s (Kite) potential strategy to increase patient referrals for Yescarta over ASCT.

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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 Becomes the First Approved CAR-T for 2L LBCL in the US

On Friday, April 1, Gilead (Kite) announced (press release) that the FDA approved Yescarta (CD19 CAR-T) in 2L LBCL based on results from the Ph3 ZUMA-7 trial. Of note, Yescarta has become the first CD19 CAR-T to move into an earlier line of therapy for LBCL. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days.   

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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 Yescarta Study in R/R DLBCL for Outpatient Administration

On Friday, November 5, a new investigator-initiated study evaluating Gilead (Kite)’s Yescarta (CD19 CAR-T) in the outpatient setting for r/r DLBCL was observed on CT.gov. Below, Celltelligence provides details for this trial, while discussing how this Yescarta outpatient study compares to key competitor Breyanzi (BMS’s CD19 CAR-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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Will Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus and cilta-cel.

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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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BMY: Q1 2021 Earnings Call Summary

On Thursday, April 29, BMS held their Q1 2021 earnings call (press release / presentation), highlighting the rapid onboarding of ATCs for Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T) in the US. Below, Celltelligence provides insights on how BMS may leverage Breyanzi and Abecma onboarding as a package for centers hesitant to offer a third CD19 CAR-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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BMS Announces New EU Manufacturing Site in the Netherlands; AUTO4 (TRBC1 CAR-T) Receives Innovation Passport and ILAP Designation; Allogene’s ALLO-715 Receives RMAT Designation by the FDA; No Major Updates in April’s CHMP Agenda

On Thursday, April 22, BMS announced (press release) that they plan to build a new cell therapy manufacturing site in Europe. Furthermore, Autolus confirmed (press release) that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted AUTO4 an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) evaluating the TRBC1-targeting CAR-T in a Ph1/2 trial for peripheral T cell lymphoma (PTCL). Allogene announced (press release) that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 (BCMA CAR-T) for the Ph1 UNIVERSAL trial in r/r MM. Finally, no major regulatory updates were observed for Abecma, Breyanzi, or cilta-cel from this week’s April CHMP Agenda (publication). Below, Celltelligence provides insights into BMS’s potential manufacturing strategy in Europe. Moreover, Celltelligence will provide thoughts on AUTO4’s ILAP designation and how this may accelerate approvals compared to the EMA’s PRIME designation, while discussing ALLO-715’s RMAT designation.

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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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Precision Regains Control of Their Allogeneic CAR-T Pipeline and Shifts Focus to their Stealth Cell Program; Alan List Joins Precision as CMO

On Thursday, April 15, Precision BioSciences announced (press release / presentation) that they have entered into a Program Purchase Agreement to reacquire all global rights for their allogeneic CAR-T program. Furthermore, Alan List was appointed (press release) as the company’s new Chief Medical Officer (CMO) and a member of the senior leadership team. Below, Celltelligence provides insights on Precision’s decision to fully control their allogeneic pipeline and how Precision’s new senior leadership could potentially accelerate stealth cell clinical development.

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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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