Tag Archives: AUTO1

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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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 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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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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Autolus Pivots Manufacturing Away from the US; TCR2 Takes Over Autolus’s Rockville Facility; Is Confidence in AUTO1 Wavering?

On Monday, March 29, Autolus announced (press release) an update to their manufacturing strategy for the commercial supply of AUTO1 (CD19 CAR-T). Autolus aims to expand existing operations in the UK while terminating the lease for their US manufacturing facilities in Rockville, MD. Moreover, on the same day, TCR2 Therapeutics announced (press release) that they are seeking to accelerate commercial-scale manufacturing timelines by leasing a new manufacturing facility in Rockville, MD. Below, Celltelligence provides thoughts on Autolus’s manufacturing strategy, while contrasting Autolus’s possible headwinds with TCR2’s potential opportunities.

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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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Five New Autolus CAR-T Products to Enter the Clinic in 2021; AUTO1’s ALL Market Opportunity; Autolus Q4 2020 Earnings Call Summary

On Thursday, March 4, Autolus held their Q4 2020 earnings presentation (press release / slides). Management presented AUTO1’s possible market strategy in adult ALL and updated several clinical milestones. Of note, Autolus’s cash runway has been extended from 2022 to H1 2023. Below, Celltelligence provides insights into Autolus’s pipeline diversification and AUTO1’s commercial 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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Clinical Updates and Market Opportunities for AUTO1 and AUTO3; ASH Day 3 Autolus Investor Event

On Monday, December 7, 2020, Autolus held an investor event (presentation / webcast) discussing recent advances to their AUTO1 (CD19 CAR-T) in ALL and AUTO3 (CD19/CD22 CAR-T) in DLBCL programs. Below, Celltelligence provides insights into AUTO3’s potential use in the outpatient setting and AUTO1’s market opportunity in adult and pediatric ALL.

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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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Kymriah Demonstrates a Favorable Safety Profile in FL; Updated Results for AUTO1’s Ph1 ALLCAR19 Trial in ALL and iNHL; Initial Data from Cellectis’s UCART22 Ph1 BALLI-01 Study; ASH Day 1 Encore

On the first day of ASH 2020, three key clinical updates were presented from Novartis, Autolus, and Cellectis. 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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AUTO1 and AUTO3 Clinical Updates to be Presented at ASH 2020; AUTO3 Pivotal Trial Likely in H1 2021; Autolus Q3 2020 Earnings Call Summary

On Thursday, November 5, Autolus held their Q3 2020 earnings call (press release/ presentation). Management highlighted that updated data from the AUTO1 Ph1 ALLCAR19 and AUTO3 Ph1/2 ALEXANDER studies will be presented at ASH 2020. Additionally, Autolus noted that AUTO3 may move to a pivotal trial in H1 2021. Below, Celltelligence provides insights into Autolus’s clinical updates at ASH 2020 and how AUTO3 could disrupt the increasingly crowded ≥3L DLBCL space.

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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 Autolus AUTO1 Pivotal Trial in Adult ALL Posted

A new Autolus-sponsored AUTO1 Ph1b/2 AUTO1-AL1 trial in r/r adult ALL has been observed on CT.gov. Of note, the trial uses a split dosing regimen. Below, Celltelligence provides insights on this new pivotal trial and how a split dose could differentiate Autolus’s position compared to CAR-T leaders Novartis and Gilead in r/r adult ALL.

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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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