Tag Archives: Legend

Cilta-cel on Track to Gain FDA Approval in Q4 2021; JNJ Q3 2021 Earnings Call Summary

On Tuesday, October 19, JNJ held their Q3 2021 earnings presentation (press release / presentation) highlighting cilta-cel’s (BCMA CAR-T) anticipated FDA approval by YE 2021. Below, Celltelligence provides insights on cilta-cel’s potential US and EU regulatory timelines.

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Cilta-cel’s Potential Off-Label Use in the US; Could BMS’s KarMMa-3 Trial Design Limit Abecma’s Targetable Population? Legend / JNJ Pivot to Earlier Lines; Legend Explores Allogeneics, CAR-NKs, and Novel Solid Tumor Targets; Legend’s R&D Day

On Monday, October 18, Legend held an R&D day (presentation) detailing preclinical and clinical assets across their BCMA, allogeneic, and solid tumors programs. Below, Celltelligence provides insights on Legend’s LCM strategy for cilta-cel (BCMA CAR-T) and possible ‘off-label’ usage in the US, while discussing the company’s allogeneic and solid tumors platforms.

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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 the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional 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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Adaptimmune’s ADP-A2M4CD8 Has a Best Response With Ovarian Cancer Patients; Legend’s LB1901 Ph1 Trial Initiated in the US

On Monday, September 13, Adaptimmune reported (press release / presentation) updated data from ADP-A2M4CD8’s (MAGE-A4 SPEAR-T) Ph1 SURPASS study for multiple solid tumors. Of note, Adaptimmune highlighted ADP-A2M4CD8’s safety profile and compared initial efficacy data to the company’s first-generation MAGE-A4 SPEAR-T therapy (afami-cel; formerly ADP-A2M4). On the same day, Legend announced (press release) the start of LB1901’s (CD4 CAR-T) Ph1 trial in the US for r/r peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Below, Celltelligence provides insights on which indications Adaptimmune could prioritize, while discussing Legend’s clinical development of LB1901 in the TCL setting.

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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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Cilta-cel’s Review Progresses in the US and EU; Legend Continues Expanding their CARTITUDE Program; Legend Q2 2021 Earnings Call Summary

On Monday, August 23, Legend released their Q2 2021 results (press release) highlighting the initiation of cilta-cel’s (BCMA CAR-T) review processes for r/r MM in the US and Europe. Furthermore, management noted the expansion of the CARTITUDE program with the initiation of a Ph3 CARTITUDE-5 trial for newly diagnosed MM (NNMM) patients. Below, Celltelligence provides insights on likely US and EU approvals for cilta-cel, while commenting on Legend’s aggressive strategy to move cilta-cel into earlier lines of therapy.

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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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Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and 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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New Legend Ph1 Trial for LCAR-T2C (CD4 CAR-T) in R/R T Cell Lymphoma Posted

On Thursday, July 22, a new Legend-sponsored Ph1 trial in China evaluating LCAR-T2C (CD4 CAR-T) for r/r T cell lymphoma (TCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing Legend’s CD4 CAR-T global clinical development, and how LCAR-T2C compares to Autolus’s AUTO4 program.

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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 Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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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Cilta-cel Demonstrates Improved Efficacy in Matched Analyses vs SoC; Cilta-cel’s New CARTITUDE-5 Trial in NDMM; Anakinra Prophylaxis Fails to Improve Orva-cel’s Safety Profile; Initial Clinical Data from Celyad’s CYAD-211 BCMA CAR-T; Gracell’s Investor Event: Will MRD Negativity Become a New Surrogate Marker? Updated Clinical Data from IASO’s CT103A; EHA 2021 Day 2

On the second day of EHA 2021, six key clinical updates were presented from JNJ / Legend, BMS, Celyad, Gracell, and IASO Biotherapeutics. Of note, Celyad and Gracell held two EHA-related investor events, while a new clinical trial for cilta-cel was observed on CT.gov. Below, Celltelligence provides insights and context for each presentation.

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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 Continues to Demonstrate Best-in-Class Efficacy With an Improved Safety Profile; Abecma’s Efficacy in Hard-to-Treat Subgroups; Could Gracell’s FasTCAR GC012F (BCMA x CD19) Further Decrease TATs? Thoughts on Arcellx’s Initial Results From CART-ddBCMA; ASCO 2021 Day 4

On the final day of ASCO 2021, eight key clinical updates were presented from JNJ / Legend, BMS, Gracell, and Arcellx. Below, Celltelligence provides insights and context for each presentation.

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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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