Tag Archives: Autolus

Autolus’s Obe-cel US Regulatory Filing Planned for Early 2023; BMS Invests in Clade Therapeutics; New Gracell CD19 UCAR-T Ph1 Trial in R/R B-ALL and B-NHL Posted; Autolus Q3 2021 Earnings Call Summary

On Wednesday, November 3, Autolus held their Q3 2021 earnings call (press release / presentation) highlighting updates from obe-cel (CD19 CAR-T; formerly AUTO1) and their next-generation candidates. On the same day, Clade Therapeutics announced (press release) that they have secured $87M in Series A financing with participation from BMS. Finally, a new Gracell early Ph1 trial evaluating an allogeneic CD19 UCAR-T in r/r B-ALL and B-NHL was observed on CT.gov.

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Autolus Announces Progress with New UK Manufacturing Site

On Thursday, September 16, Autolus announced (press release) planning approval for a new manufacturing facility in Stevenage, UK. Of note, the manufacturing facility will initially provide ~2,000 doses a year of obe-cel (CD19 CAR-T; formerly AUTO1). Below, Celltelligence provides insights into Autolus’s manufacturing strategy, while discussing whether the new facility could enhance Autolus’s potential to be acquired.

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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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Autolus Appoints John Johnson to Their Board of Directors

On Wednesday, September 15, Autolus announced (press release) John Johnson’s appointment as non-executive chairman of their Board of Directors. Additionally, Martin Murphy, who previously served as chairman, will continue to serve as a non-executive board member. Below, Celltelligence provides insights on Autolus’s leadership strategy to prepare for obe-cel’s (CD19 CAR-T, formerly AUTO1) commercial launch, while commenting on the potential acquisition of Autolus.

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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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bluebird’s Oncology Newco on Track to Launch in Q4 2021; Autolus’s obe-cel Granted PIM Designation by the MHRA; bluebird bio Q2 2021 Earnings Call Summary

On Monday, August 9, bluebird bio held their Q2 2021 earnings call (press release / presentation) highlighting Abecma’s successful US launch and providing updates on bluebird’s upcoming business separation. Additionally, management commented on bluebird’s recent manufacturing alliance with Resilience. On the same day, Autolus announced (press release) that obe-cel (CD19 CAR-T) has received Promising Innovative Medicine (PIM) designation from the MHRA in r/r adult ALL.

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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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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 Legend Ph1 Trial for LCAR-T2C (CD4 CAR-T) in R/R T Cell Lymphoma Posted

On Thursday, July 22, a new Legend-sponsored Ph1 trial in China evaluating LCAR-T2C (CD4 CAR-T) for r/r T cell lymphoma (TCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing Legend’s CD4 CAR-T global clinical development, and how LCAR-T2C compares to Autolus’s AUTO4 program.

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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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Autolus Appoints Edgar Braendle as Chief Development Officer

On Thursday, July 15, Autolus announced (press release) the appointment of Edgar Braendle as Chief Development Officer (CDO). Below, Celltelligence provides insights on how Edgar Braendle’s vast oncology experience could accelerate the development and commercialization of Autolus’s lead asset, obe-cel (CD19 CAR-T, formerly AUTO1).

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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 Tmunity’s Decision to Drop TmPSMA-01: Will Companies Opt for More CAR-T Engineering or Better Drugs to Manage MAS?

Tmunity recently disclosed that the FDA enforced the termination of their TmPSMA-01 (PSMA CAR-T) Ph1 trial in prostate cancer following the death of two patients (press release). Below, Celltelligence provides insights on how Tmunity’s PSMA CAR-T compares with key competitors Poseida (P-PSMA-101) and Autolus (AUTO7), while discussing how additional engineering or pharmacological intervention could be needed to improve CAR-T safety in solid tumors.

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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 Next-Generation Modules be Enough to Differentiate Autolus’s Products? Ziopharm Deprioritizes Several Programs; What Targets and Indications Could Cellectis Pursue Next? Autolus, Ziopharm, and Cellectis Q1 2021 Earnings Call Summaries

On Thursday, May 6, Autolus held their Q1 2021 earnings call (press release / presentation) highlighting several anticipated AUTO1 data updates in 2021 while providing details on their next-generation programs and manufacturing strategy. On the same day, Ziopharm presented their Q1 2021 results (press release / presentation) announcing the deprioritization of their controllable IL-12 gene therapy and their allogeneic CD19 RPM programs. Furthermore, Cellectis reported their Q1 2021 financial results (press release) commenting on the progress of their clinical program and a series of R&D events to be held between May 24 — 28.

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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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