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Obe-cel’s BLA Submission on Track for YE 2023; Launch Preparedness Activities Underway; Cardinal Health to Serve as Autolus’s US Commercial Distribution Partner; Autolus’s Q1 2023 Earnings Call Summary

Autolus has had a series of updates recently, including a Capital Markets Day, an earnings call, and other related news items. On Thursday, May 4, Autolus held its Q1 2023 earnings call (press release / presentation) highlighting that obe-cel’s BLA submission to the FDA remains on track for YE 2023. Below, Celltelligence provides summary and insight on the recent updates from Autolus, including obe-cel’s launch approach and the company’s US distribution agreement with Cardinal Health.

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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 Breyanzi Marketing Authorization in 2L LBCL

On Wednesday, May 3, BMS announced (press release) that the European Commission (EC) has granted Breyanzi (CD19 CAR-T) approval for the treatment of ≥2L LBCL patients that have relapsed within 12 months or that are refractory to 1L chemoimmunotherapy. Below, Celltelligence provides insights on Breyanzi’s approval in the EU, while comparing it with its key competitor Yescarta (Gilead’s CD19 CAR-T).

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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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JNJ to Invest in CAR-T Therapies for Lymphoma

On Tuesday, May 2, JNJ announced (press release) a WW agreement with Cellular Biomedicine Group (CBMG) for the development, manufacturing, and commercialization of two novel cell therapies, C-CAR039 (prizloncabtagene autoleucel; CD20 x CD19 CAR-T) and C-CAR066 (CD20 CAR-T) for the treatment of B-cell malignancies. Below, Celltelligence provides insights on JNJ’s cell therapy pipeline extension and new interest in the lymphoma space while discussing its potential direct competitors in the 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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Thoughts on Breyanzi Positive Results in R/R FL and MCL

On Monday, May 1, BMS announced (press release) positive topline results from Breyanzi’s (CD19 CAR-T) Ph2 TRANSCEND FL trial for patients with ≥3L FL and from its pivotal Ph1 TRANSCEND NHL 001 for ≥3L MCL. Below, Celltelligence provides insights on how Breyanzi compares to its key competitor CD19 CAR-Ts, Novartis’s Kymriah and Gilead’s Yescarta for ≥3L FL, and Gilead’s Tecartus for ≥3L MCL, while discussing its potential approval timelines for both indications in the US.

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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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Gilead’s Cell Therapy Revenues Continue to Grow; Arcellx and Tmunity Deals Completed; Yescarta and Tecartus NICE Recommendations in England; Gilead’s Q1 2023 Earnings Call Summary

On Thursday, April 27, Gilead (Kite) held its Q1 2023 earnings call (press release / presentation) highlighting the increased sales for Yescarta and Tecartus and the clinical milestones of its cell therapy franchise. Additionally, on April 27, NHS England announced an expansion of access for Yescarta and Tecartus (press release), following NICE recommendations for 2L LBCL and adult B-ALL respectively. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing the potential of recent approvals in several geographies to increase ex-US sales for Yescarta and Tecartus.

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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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Abecma and Breyanzi Sales Accelerate; Initiation of CAR-T Program in Immunology; Vector Manufacturing Facility Acquisition; Leadership Transition Plan; BMS’s Q1 2023 Earnings Call Summary

On Thursday, April 27, BMS held its Q1 2023 earnings call (press release / presentation) highlighting significant revenue increase from both Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Importantly, BMS disclosed its intention to initiate a Ph1 trial evaluating CD19 NEX-T CAR-T in severe refractory systemic lupus erythematosus (SLE). Additionally, on Wednesday, April 26, BMS announced that Giovanni Caforio, CEO and Chairman of the Board will retire on November 1, 2023 (press release). Finally, on the same day, BMS reported the acquisition of Novartis’s in-house viral vector production facility at Libertyville, Illinois, US (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed assets and its intention to enter the autoimmune field.

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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 April’s CHMP Highlights

On Wednesday, April 26, the CHMP meeting highlights were released. In line with Monday’s CHMP agenda (see previous insight), no cell therapy-related updates were observed in April’s CHMP highlights.

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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 Sales Decrease; Prioritization of CAR-T Therapies for Immunology over LBCL and MM; Novartis Strategy for Contract Manufacturing; Novartis’s Q1 2023 Earnings Call Summary

On Tuesday, April 25, Novartis held their Q1 2023 earnings call (press release / presentation) reporting $135M in Kymriah’s (CD19 CAR-T) WW sales. Of note, the company disclosed the prioritization of CAR-T programs in immunology over LBCL and MM indications. Below, Celltelligence provides insights on Kymriah’s Q1 2023 revenue, while discussing YTB323’s (T-Charge CD19 CAR-T) potential in the immunologic space and Novartis’s contract manufacturing strategy.

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

On Monday, April 24, the CHMP Agenda for April was released. Of note, no cell therapy-related updates were observed. Recall that Abecma’s (BMS’s BCMA CAR-T) indication extension to ≥3L MM patients could potentially be included in May’s CHMP agenda (see previous insight).

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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Thoughts on CARTITUDE-4’s EHA Abstract Being Prematurely Posted; Carvykti Demonstrates an Impressive Efficacy Profile in 2-4L MM

On Tuesday, April 18, Carvykti’s (JNJ / Legend’s BCMA CAR-T) topline results of its Ph3 CARTITUDE-4 trial were reported after its abstract was unintentionally posted on EHA’s website. The results suggest a superior efficacy profile of Carvykti over SOC therapy (news, Endpoints News, Apr 2023). Below, Celltelligence provides insights on Carvykti’s outstanding performance compared to SOC while discussing its potential to become the new SOC therapy in the 2L MM setting.

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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