Category Archives: Autologous

Kymriah Sales Remain Flat Despite Japan Approval in ≥3L FL; Kymriah’s LCM Initiatives Deprioritized; YTB323’s Plans Under Review; Novartis Q3 2022 Earnings Call Summary

On Tuesday, October 25, 2022, Novartis held their Q3 2022 earnings call (press release / presentation) reporting $134M in Kymriah’s WW sales. Of note, Kymriah’s pivotal Ph2 CASSIOPEIA trial in 1L HR ALL was removed from Novartis’s pipeline and YTB323’s (T-Charge CD19 CAR-T) Ph3 trial initiation has been delayed. Below, Celltelligence provides insights on Kymriah’s Q3 2022 revenue, while discussing Kymriah’s LCM initiative deprioritization and YTB323’s delayed development strategy.

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Carvykti’s Revenue Increases to $55M; JNJ Expects Franchise to Generate $5B by 2025; Will Carvykti be Approved in 2L MM by Q3 2023? JNJ Q3 2022 Earnings Call Summary

On Tuesday, October 18, JNJ held their Q3 2022 earnings call (press release / presentation) highlighting Carvykti’s (JNJ / Legend’s BCMA CAR-T) potential to generate $5B by 2025. Additionally, management confirmed that a data readout from Carvykti’s Ph3 CARTITUDE-4 trial in 2-4L MM is expected by YE 2022. On the same day, Legend disclosed (SEC filing, Oct 2022) that Carvykti’s preliminary WW sales for Q3 2022 were $55M. Below, Celltelligence provides insights on Carvykti’s revenue increase, while discussing potential US regulatory timelines for Carvykti in 2L MM.

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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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The EC Grants Yescarta Marketing Authorization in 2L LBCL

On Monday, October 17, Gilead (Kite) announced (press release) that the European Commission (EC) has granted Yescarta approval (CD19 CAR-T) for the treatment of DLBCL and high-grade B-cell lymphoma (HGBL) refractory patients or that have relapsed within 12 months of 1L chemoimmunotherapy (2L LBCL). Below, Celltelligence provides insights on Yescarta’s approval in the EU, while comparing it with key competitor Breyanzi (BMS’s CD19 CAR-T).

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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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No Cell Therapy-Related Updates in October’s CHMP Agenda

On Monday, October 10, the CHMP agenda for October was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that Breyanzi’s (BMS’s CD19 CAR-T) indication extension to 2L LBCL transplant-intended (TI) patients could potentially be included in November’s CHMP agenda (see previous insight).

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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 Carvykti be Approved in 2L MM by 2023? Legend Introduces New γδ CAR-T Program; Updates to Solid Tumor Programs; Thoughts on Legend’s R&D Day 2022

On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.

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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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BMS to Leverage Autolus’s Safety Switch

On Tuesday, October 4, Autolus announced (press release) that it has entered into an agreement with BMS. Under the agreement, BMS will be granted access to Autolus’s proprietary RQR8 safety switch, while Autolus will receive upfront and milestone payments. Below, Celltelligence provides insights on Autolus’s safety switch, while discussing how BMS could leverage RQR8.

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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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TCR2 Tx Completes Gavo-Cel’s Ph1 Trial; Dosing Started in Gavo-cel’s Pivotal Ph2 Study; Gilead’s KITE-222 Receives Orphan Drug Designation

On Wednesday, September 28, 2022, TCR2 Tx held an investor event highlighting positive topline results from gavo-cel’s (TC-210; autologous mesothelin TRuC-T) Ph1 portion of the Ph1/2 trial (press release / presentation). On Tuesday, September 27, Gilead’s (Kite) KITE-222 (autologous CLL-1 CAR-T) was granted Orphan Drug Designation (ODD) by the FDA (FDA Designation). Below, Celltelligence provides insights on gavo-cel’s positive clinical results and future pivotal development as well as discusses KITE-222’s ODD in AML.

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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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Carvykti Approved in Japan for ≥4L r/r MM

On Tuesday, September 27, Legend announced (press release) that Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved Carvykti (BCMA CAR-T) for the treatment of ≥4L r/r MM. Below, Celltelligence provides insights on how Carvykti’s approval may challenge Abecma’s (BMS’s BCMA CAR-T) first-to-market advantage in Japan, while discussing Carvykti’s potential pricing.

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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 Novartis Deprioritize T-Charge? Novartis to Focus Exclusively on Innovative Medicines; Thoughts on Novartis Meet the Management Investor Event 2022

On Thursday, September 22, Novartis held its “Meet Novartis Management” investor event (press release / presentation), highlighting an organizational restructuring, while noting uncertainty regarding its rapid cell therapy manufacturing platform, T-Charge. Below, Celltelligence provides insights on the potential deprioritization of the T-Charge platform, while discussing what novel cell therapy technologies Novartis could leverage for its next wave of cell therapy assets.

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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 JNJ Change the Treatment Paradigm in MM? Spotlight on JNJ’s MM Franchise

During 2022, JNJ’s (Janssen) MM franchise achieved major regulatory milestones that have positioned the company as a key player in the MM landscape. Carvykti’s (cilta-cel; BCMA CAR-T) US approval, EU approval, and Tecvayli’s (teclistamab; BCMA x CD3 bispecific antibody) recent conditional marketing authorization in the EU could potentially allow JNJ to change the treatment paradigm in MM. Below, Celltelligence provides insights on how JNJ could leverage its large MM portfolio and pipeline to disrupt the current SOC regimens for MM, as well as what may be going on with Tecvayli’s US regulatory delay.

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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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