Tag Archives: Autolus

Obe-cel’s Data Update Expected in Q4 2022; Afami-cel’s BLA Remains on Track for Q4 2022; Adaptimmune to Slow Down ADP-A2M4N7X19’s Development; Autolus and Adaptimmune Q2 2022 Earnings Summaries

On Thursday, August 4, Autolus held their Q2 2022 earnings call (press release / presentation) highlighting that initial data from obe-cel’s (CD19 CAR-T) Ph2 FELIX trial will be reported in Q4 2022. Additionally, multiple data updates from AUTO1/22 (CD19 x CD22 CAR-T) and AUTO4 (TRBC1 CAR-T) are expected at ASH 2022. On the same day, Adaptimmune reported their Q2 2022 financial results (press release) confirming afami-cel’s (MAGE-A4 SPEAR-T) anticipated BLA filing in Q4 2022, and a delayed IND submission for ADP-A2M4N7X19 (next-generation MAGE-A4 SPEAR-T). Below, Celltelligence provides insights on obe-cel’s potential approval, while discussing afami-cel’s BLA filing.

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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated its CD19 CAR-T indications table for estimated US approvals and submissions following key Q1 2022 earnings presentations and recent press releases (see below for download).

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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 Presents Updated Results for Obe-cel, AUTO1/22, and AUTO4; Autolus’s EHA 2022 Investor Event; Academic BCMA CAR-T ARI0002h Reports Encouraging Efficacy in R/R MM; EHA 2022 Final Analysis

EHA 2022 Final Analysis: Autolus presented clinical results for obe-cel, AUTO1/22, and AUTO4, while Hospital Clinic Barcelona reported data from ARI0002h. Moreover, Autolus held an investor call following updated clinical data presented at EHA 2022. Below, Celltelligence provides insights and context for key selected presentations and highlights from the call. The following topics are covered below:

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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’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

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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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Obe-cel’s US Filing Delayed to H2 2023; Stevenage Manufacturing Site to be Operational by Mid-2023; Autolus Q4 2021 Earnings Call Summary

On Thursday, March 10, Autolus held their Q4 2021 earnings call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) regulatory delays, while confirming multiple clinical updates at EHA 2022. Furthermore, Autolus provided further manufacturing and executive updates. Below, Celltelligence provides insights on how Autolus may try to offset obe-cel’s delayed potential US approval, while discussing Autolus’s manufacturing strategy and AUTO1/22’s market opportunity.

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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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Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

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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Autolus’s Industrialized Manufacturing Process for Obe-cel; Updated Results From Autolus’s Ph1 ALLCAR19 and Ph1 CARPALL Trials; ASH 2021 Day 3 Autolus Investor Event

On Monday, December 13, Autolus held their investor event (press release / presentation) comparing obe-cel’s (CD19 CAR-T; formerly AUTO1) Ph1 ALLCAR19 study and Ph1b/2 FELIX trial in r/r B-ALL. Moreover, management provided updated preclinical and clinical data for obe-cel’s ALLCAR19 iNHL cohort and AUTO1/22 (CD19 x CD22 CAR-T) in r/r pediatric ALL. Below, Celltelligence provides insights on obe-cel’s industrialized manufacturing process, while discussing Autolus’s AUTO1/22 indication 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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Could Autolus’s AUTO1/22 Novel CD22 Binder Avoid Antigen-Related Relapse in ALL? Updated Results from Cellectis’s UCART22 Ph1 BALLI-01 Trial; Yescarta’s Ph2 ZUMA-5 Trial Continues to Demonstrate Positive Long-Term Results; ASH 2021 Day 1 Part 1

On the first day of ASH 2021, 3 clinical updates were presented by Autolus, Cellectis, and Gilead. Below, Celltelligence provides insights and context for each presentation. In a subsequent blast, the Celltelligence team will provide insights from Precision’s PBCAR0191 (allogeneic CD19 CAR-T) clinical update and results from both Ph3 2L DLBCL studies from BMS (Breyanzi; CD19 CAR-T) and Gilead (Yescarta; CD19 CAR-T).

About The Author

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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William Young Appointed as a Non-Executive Director of Autolus’s Board of Directors

On Monday, November 15, Autolus announced (press release) that William Young, Senior Advisor to Blackstone Life Sciences, has been appointed as a non-executive director to their Board of Directors, effective immediately. Of note, Young’s appointment follows Autolus’s recent collaboration with Blackstone. Below, Celltelligence provides insights on how Autolus could leverage Young’s operational experience to facilitate obe-cel’s (CD19 CAR-T, formerly AUTO1) launch.

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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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Why Blackstone’s $250M Investment in Autolus Is Necessary for Obe-cel’s Clinical Development

On Monday, November 8, Autolus announced (press release) that they have entered into a collaboration and financing agreement with Blackstone Life Sciences for the development of obe-cel (CD19 CAR-T, formerly AUTO1) and obe-cel’s next-generation therapies in B cell malignancies. Below, Celltelligence provides insights on how Autolus’s collaboration with Blackstone could secure obe-cel’s clinical development while giving the company flexibility to develop other assets within their pipeline.

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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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