Tag Archives: CAR-T

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 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 BMS’s New Abecma Ph1/2 KarMMa-7 Basket Combination Trial

On Thursday, April 22, a new Abecma (BCMA CAR-T) Ph1/2 combinational trial (KarMMa-7) for the treatment of r/r MM was observed on CT.gov. Below, Celltelligence provides insights on how BMS could strategically leverage the Ph1/2 KarMMa-7 trial to improve Abecma’s efficacy while investigating several fully owned compounds to disrupt the current SOC regimens for 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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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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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 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 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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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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First BCMA CAR-T Approved in the US for Multiple Myeloma; Will Abecma’s 33-day TAT and High Price Prevent Wide-Spread Adoption?

On Friday, March 26, BMS and bluebird bio announced (press release) that the FDA approved Abecma (idecabtagene vicleucel) for the treatment of ≥5L r/r MM (i.e. after completing at least 4 lines of prior therapy). Below, Celltelligence provides thoughts on Abecma’s higher list price and longer TAT vs. approved CD19 CAR-Ts, while discussing Abecma’s potential messaging strategy.

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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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Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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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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No Major Updates Presented at Ziopharm’s R&D Day

On Thursday, March 11, Ziopharm held their R&D day (presentation) where they presented no major updates for their CD19 rapid manufacturing (RPM) CAR-T program or their personalized / library TCR-T approach. Nevertheless, management reiterated that their CD19 RPM cells could potentially cost $10,000, with a dose x100 lower than traditional autologous CAR-Ts. Finally, Ziopharm presented initial results from the CD19 RPM CAR-T investigator-initiated trials, highlighting the CAR-T’s acceptable tolerability profile (see image 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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New Gilead KITE-222 (CLL-1 CAR-T) Ph1 Trial in R/R AML Posted

On Tuesday, March 9, a new Gilead (Kite) sponsored Ph1 trial was observed on CT.gov for a first-in-human study of KITE-222 (autologous CLL-1 CAR-T) in r/r acute myeloid leukemia (AML). Below, Celltelligence provides insights on the significance of Gilead expanding their pipeline into the AML setting and the potential competitors within the space.

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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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