Tag Archives: Autolus

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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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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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 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 Autolus Suitors for AUTO3

On Wednesday, January 13, Autolus disclosed at JPM 2021 their intention to develop and commercialize AUTO3 through a partnership with another company (see previous insight). Below, Celltelligence provides thoughts on the likelihood of Autolus partnering with companies such as Merck, AZ, Pfizer, Takeda, Roche, GSK, and JNJ.

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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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JPM 2021 Day 3: Allogene, Autolus, and Tmunity

On the third day of JPM 2021, Celltelligence covered presentations by Allogene (presentation), Autolus (presentation), and Tmunity (presentation). Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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 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 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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Updated AUTO3 Ph1/2 ALEXANDER Results; ESMO 2020 Investor Call Summary

On Friday, September 18, Autolus held an investor call (press release / presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 ALEXANDER study in ≥3L DLBCL. The data was also presented at ESMO (E.Tholouli et al, Sep 2020). Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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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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