Tag Archives: LEADING COMPANIES

No Cell Therapy-Related Updates in May’s CHMP Agenda; Abecma Likely to Be Included in June’s Agenda

On Monday, May 22, the CHMP Agenda for May was released. Of note, Abecma’s (BMS’s BCMA CAR-T) Type II Variation (T2V) for ≥3L MM was absent from the agenda, and no other cell therapy-related updates were observed. Therefore, based on the agenda, no updates are expected on the CHMP highlights to be published on Friday, May 26.

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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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SC-DARIC33 Shows Promising Preliminary Clinical Results; 2seventy Bio Reveals Next-Generation AML Program; ASGCT 2023 Analysis 2

ASGCT 2023 Analysis 2: 2seventy bio presented preliminary clinical results of SC-DARIC33’s (autologous drug-regulated CD33 CAR-T) Ph1 PLAT-08 trial and several updates on preclinical assets at ASGCT. Moreover, on Friday, May 19, the company held a virtual R&D Deep Dive event further detailing the data presented at ASGCT 2023, disclosing the main features of its new AML asset 27T32 (next-generation autologous drug-regulated CD33 x CLL1 dual CAR-T) and confirming anticipated milestones for the rest of their pipeline assets (presentation). Below, Celltelligence provides insights on the potential advantage that drug-regulated activation could confer to SC-DARIC33 over other cell therapies in the AML space while commenting on the novel asset, 27T32, disclosed by the company.

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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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Legend to Present Multiple Updates at ASCO and EHA 2023; Legend to Use Raised Funding for Carvykti’s Development; Legend’s Q1 2023 Earnings Summary

On Thursday, May 18, Legend reported its Q1 2023 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) upcoming clinical presentations at ASCO and EHA 2023, and its WW revenue during this period. Below, Celltelligence provides insights on CARTITUDE-4 data to be presented in the upcoming conferences and Carvykti’s future development.

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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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Why Kite’s New Leader Makes Strategic Sense for Gilead; Allogene’s CMO Pursues Other Opportunities

On May 16, Gilead (Kite) announced the appointment of Cindy Perettie as EVP of Kite (press release), overseeing the cell therapy business. Moreover, on May 18, Replay Bio announced (press release) the appointment of Allogene’s former CMO, Arun Balakumaran, as the company’s new CMO. Below, Celltelligence provides insights on how Perettie’s healthcare experience and background could benefit Gilead’s pursuit of bringing cell therapy to solid tumors.

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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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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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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 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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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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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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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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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

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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 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.

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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