Category Archives: Uncategorized

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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New Academic CD19 CAR-T ARI-0001 Ph2 Trial in R/R ALL Posted

On Wednesday, March 3, a new ARI-0001 (autologous CD19 CAR-T) Ph2 trial (CART19-BE-02) was observed on CT.gov for the treatment of adult r/r ALL. Below, Celltelligence provides details for this trial and how ARI-0001’s point-of-care (PoC) model could potentially be replicated in other countries if proven successful.

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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 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

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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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Could Kymriah Have Become the CAR-T Market Leader in Q4 2020? PORTIA Deprioritized; No Updates on Cilta-cel’s Regulatory Submissions; Novartis and JNJ Q4 2020 Earnings Call Summaries

On Tuesday, January 26, Novartis (press release / presentation) and JNJ (press release / presentation) held their Q4 2020 earnings calls. Novartis highlighted Kymriah’s FY 2020 WW growth of 68% YoY, while JNJ confirmed the rolling submission of cilta-cel’s BLA in December 2020. Below, Celltelligence provides insights on how Kymriah could become the CAR-T market leader, Novartis’s reprioritization of the Ph1b PORTIA trial (Kymriah + pembrolizumab), and the possibility of an August US approval for cilta-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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CHMP Agenda Includes Hidden Request for Cilta-cel Accelerated Assessment; Precision Issued with a Notice of Allowance for PBCAR19B’s Patent

On Monday, January 25, the CHMP indirectly announced (CHMP agenda) that JNJ / Legend have requested an accelerated assessment for cilta-cel (BCMA CAR-T) in r/r MM, although the documentation only lists the code number for cilta-cel. Additionally, Precision BioSciences announced (press release) that the USPTO has issued a notice of allowance for PBCAR19B, a next-generation CD19 CAR-T. Below, Celltelligence provides insights on how a 1-month delay in filing cilta-cel could result in a 2-month delay for EC approval, an update on ide-cel’s estimated EU approval lead, and the significance of Precision’s latest patent milestone.

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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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Yescarta Approved in Japan; Early Reimbursement Likely by March; UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated approvals and submissions following presentations from JPM 2021 (see below for download).

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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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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

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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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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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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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JPM 2021 Day 1: BMS, bluebird bio, Novartis, and JNJ

On the first day of JPM 2021, Celltelligence covered presentations by BMS, bluebird bio, Novartis, and JNJ. 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

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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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Cilta-cel Submitted in US; Could Approval be Earlier than August 2021?

On Monday, December 21, JNJ announced (press release) the US rolling submission of cilta-cel’s (BCMA CAR-T) BLA in ≥4L r/r Multiple Myeloma (MM). Below, Celltelligence provides insights on cilta-cel’s potential approval date and how this could reduce ide-cel’s first-to-market advantage.

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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