Tag Archives: CD19

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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Thoughts on Autolus’s New Dual BCMA x CD19 CAR-T Ph1 Trial in Multiple Myeloma

On Friday, March 12, a new Autolus Ph1 trial named MCARTY was observed on CT.gov for a first-in-human study of a BCMA and BCMA x CD19 dual CAR-T in r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Autolus could differentiate themselves from competitors with BCMA CAR-T products closer to approval, while discussing engineering and dosing differences between BCMA x CD19 dual CAR-Ts from Autolus and Gracell.

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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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Thoughts on Heidi Hagen’s Appointment as Interim Ziopharm CEO; Allogene Anticipates Two New Clinical Trials in 2021; Ziopharm and Allogene Q4 2020 Earnings Call Summaries

On Thursday, February 25, Ziopharm (press release / slides) and Allogene (press release) held their Q4 2020 earnings presentations. Ziopharm announced that Heidi Hagen will act as Interim CEO replacing Laurence Cooper, while Allogene presented several clinical and regulatory updates. Below, Celltelligence provides insights into Allogene’s pipeline strategy and their efforts to target the solid tumor setting in the mid- to long-term, while providing thoughts on the appointment of Heidi Hagen as Ziopharm’s Interim CEO.

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Ide-cel Reverts to Standard Assessment; Liso-cel’s Potential Scenarios for Approval; CHMP February Agenda and Highlights

On Friday, February 26, CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, regulatory updates for BMS’s liso-cel (CD19) and ide-cel (BCMA) CAR-T products were observed, including ide-cel’s start of standard review following its loss of accelerated assessment (AA) in December 2020. No updates for cilta-cel were provided. Below, Celltelligence provides insights on possible EC approval dates for liso-cel and ide-cel.

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Spain Approves the First Potentially Low-Cost Academically Manufactured CD19 CAR-T for Adult ALL Patients; Could EMA Approval be Next?

On Wednesday, February 10, the Spanish Agency of Medicines and Medical Devices (AEMPS) announced (press release) the approval of ARI-0001 (autologous CD19 CAR-T) for the treatment of ≥3L adult r/r ALL. ARI-0001 has become the first academically manufactured CD19 CAR-T approved by a regulatory agency. The approval was based on data from the Ph1 CART19-BE-01 trial. Below, Celltelligence provides insights on how ARI-0001’s point-of-care manufacturing model and competitive price could impact commercially available CAR-Ts.

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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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No Regulatory Updates for Liso-cel; Orva-cel Discontinued; BMS Q4 2020 Earnings Call Summary

On Thursday, February 4, BMS held their Q4 2020 results (press release / presentation). Management discussed liso-cel’s possible imminent approval and their strategy for rapid ATC onboarding. Of note, BMS’s humanized BCMA CAR-T orva-cel has been discontinued. Below, Celltelligence provides insights on BMS’s potential strategy for liso-cel and thoughts on orva-cel’s discontinuation.

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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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NICE Recommends Tecartus in MCL; First Full Access Deal for Tecartus in Europe

On Tuesday, January 19, NICE announced (press release) that they have agreed to a managed access agreement with Gilead (Kite) for Tecartus (brexucabtagene autoleucel, formerly KTE-X19). Below, Celltelligence provides thoughts on Tecartus’s timely approval by NICE and which EU country could next approve Tecartus for reimbursement.

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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 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).

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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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Celgene’s CVR Payment Vanishes As Liso-cel Is Not Approved Before Dec 31, 2020

As of January 1, 2021, the FDA has not yet approved BMS’s CD19 CAR-T liso-cel, and BMS’s press release today confirmed the termination of the Celgene CVR. Below, Celltelligence provides insights on the potential for litigation following liso-cel’s missed approval deadline for Celgene’s CVR shareholders.

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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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