Category Archives: Topics

Spain Approves the First Potentially Low-Cost Academically Manufactured CD19 CAR-T for Adult ALL Patients; Could EMA Approval be Next?

On Wednesday, February 10, the Spanish Agency of Medicines and Medical Devices (AEMPS) announced (press release) the approval of ARI-0001 (autologous CD19 CAR-T) for the treatment of ≥3L adult r/r ALL. ARI-0001 has become the first academically manufactured CD19 CAR-T approved by a regulatory agency. The approval was based on data from the Ph1 CART19-BE-01 trial. Below, Celltelligence provides insights on how ARI-0001’s point-of-care manufacturing model and competitive price could impact commercially available CAR-Ts.

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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 Breyanzi’s (liso-cel) Label, Price, Manufacturing, and TAT Compared to Kymriah and Yescarta

On Friday, February 5, BMS announced (press release) that the FDA approved Breyanzi (lisocabtagene maraleucel) for the treatment of r/r LBCL after ≥2L systemic therapy, which is essentially ≥3L r/r DLBCL. The application was based on data from the Ph1 TRANSCEND NHL 001 trial. Below, Celltelligence provides insights on Breyanzi’s approval, the higher DLBCL list price vs. Kymriah and Yescarta, how BMS may position Breyanzi in the CD19 CAR-T setting, why supplying Breyanzi in vials is strategically important, and a look at the Breyanzi mobile app.

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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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Liso-cel Approved by FDA as Breyanzi

Late today, BMS announced US approval of liso-cel in r/r LBCL after >2L of systemic therapy. The press release states that the target turnaround time is 24 days from its manufacturing facility in Bothell, Washington, USA. The Celltelligence team will be conducting a full thoughts-on label review in the coming days (link to Breyanzi PI here).

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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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Yescarta’s Q4 2020 Sales Decline and Kymriah Takes a QoQ Sales Lead for the First Time; Gilead Q4 2020 Earnings Call Summary

On Thursday, February 4, Gilead (Kite) held their Q4 2020 earnings (press release / presentation). Management highlighted the overall increase in revenue for their cell therapy franchise. However, Yescarta’s WW QoQ sales decreased as a result of weak US sales. Below, Celltelligence provides insights on the potential causes for Yescarta’s reduced US revenue and how Gilead may recover market share in the short- to mid-term.

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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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No Regulatory Updates for Liso-cel; Orva-cel Discontinued; BMS Q4 2020 Earnings Call Summary

On Thursday, February 4, BMS held their Q4 2020 results (press release / presentation). Management discussed liso-cel’s possible imminent approval and their strategy for rapid ATC onboarding. Of note, BMS’s humanized BCMA CAR-T orva-cel has been discontinued. Below, Celltelligence provides insights on BMS’s potential strategy for liso-cel and thoughts on orva-cel’s discontinuation.

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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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JNJ / Legend Granted EU Accelerated Assessment for Cilta-cel; Can Cilta-cel’s MAA Submission Occur Before March 8, 2021?

On Monday, February 1, JNJ and Legend announced (press release) that the EMA granted cilta-cel (BCMA CAR-T) accelerated assessment for r/r MM. Management confirmed that they intend to file cilta-cel’s MAA during H1 2021. In case you missed it from January 25, Celltelligence revisits the likelihood of JNJ submitting an MAA by March 8, 2021 and cilta-cel’s potential regulatory timeline compared to ide-cel’s (BMS / bluebird).

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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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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.

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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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.

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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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.

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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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).

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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