Tag Archives: Lupus

Obe-cel BLA Submission Remains on Track for YE 2023; YTB323 and Obe-cel to Compete on Safety in SLE; AUTO6NG’s Trial in Neuroblastoma to Be Initiated by YE 2023; Clinical Results of AUTO8 at ASH; Autolus’s Q3 2023 Earnings Call Summary

On Thursday, November 2, Autolus held its Q3 2023 earnings call (press release / presentation) highlighting that the obe-cel (CD19 CAR-T) BLA in r/r ALL remains on track to be submitted by YE 2023. The company also disclosed the initiation of an obe-cel Ph1 trial in pediatric ALL by YE 2023 to support its MAA with the EMA, while disclosing MHRA’s approval for the evaluation of AUTO6NG (GD2 CAR-T) in the Ph1 MAGNETO trial in pediatric r/r neuroblastoma. Additionally, Novartis will present initial safety data of YTB323’s (CD19 T-Charge CAR-T) Ph1/2 trial in SLE at ACR 2023. Below, Celltelligence provides insights on the regulatory pathway of Autolus’s leading cell therapy while discussing the potential of obe-cel and AUTO8 (BCMA x CD19 CAR-T) in the autoimmune disease space compared with Novartis’s YTB323.

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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’s Cell Therapy Franchise Sales Decrease; KarMMa-9 Initiated; The FDA Clears BMS-986353’s IND in MS; First Patients in SLE Trial Dosed; BMS’s Q3 2023 Earnings Call Summary

On Thursday, October 26, BMS held its Q3 2023 earnings call (press release / presentation) disclosing a significant revenue decrease for Abecma (BCMA CAR-T) and a decline in Breyanzi (CD19 CAR-T) sales. Additionally, BMS confirmed the dosing of the first patient in the Ph1 trial evaluating BMS-986353 (CC-97540; CD19 NEX-T CAR-T) in severe refractory systemic lupus erythematosus (SLE), while announcing IND clearance from the FDA to start a trial in multiple sclerosis (MS). Below, Celltelligence provides insights on the potential causes behind the Abecma and Breyanzi sales drops while discussing the initiation of the Ph3 KarMMa-9 trial in NDMM and BMS’s fast progress in the autoimmune disease space.

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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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Obe-cel Trial in SLE on Track to Be Initiated in Early 2024; Obe-cel’s Development in Oncology Could Accelerate its Path to Market in SLE; Autolus to Leverage Infrastructure Established for ALL in Autoimmune Diseases

On Tuesday, October 24, Autolus held a virtual event (press release / presentation) highlighting its intention to initiate a Ph1 trial evaluating obe-cel (CD19 CAR-T) in systemic lupus erythematosus (SLE) in early 2024, while disclosing the company’s strategy in the autoimmune disease space. Below, Celltelligence provides insights on Autolus’s plans for autoimmune diseases and discusses how obe-cel’s previous development in oncology could be a potential advantage versus its competitors in the space.

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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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The FDA Clears NKX019’s IND in Lupus Nephritis; Nkarta Partners With Lupus Tx; Company Amends NKX019’s Trial in B-Cell Malignancies

On Tuesday, October 17, Nkarta held a conference call (webcast) highlighting the IND clearance from the FDA to evaluate NKX019 (CD19 CAR-NK) in refractory lupus nephritis (rLN) (press release) and providing clinical updates and anticipated milestones for its CAR-NK programs in hematologic malignancies. On the same day, Lupus Tx announced a partnership with Nkarta to support the early development of NKX019 in lupus (press release). Below, Celltelligence provides insights on the clinical advantages of the use of CAR-NKs in the autoimmune disease setting while discussing Nkarta’s amendments to the Ph1 trial evaluating NKX019 in B-cell malignancies.

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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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You May Have Missed: Gilead to Collaborate in the Development of TmCD19-IL18; Celularity Partners with Regeneron; Mustang Bio Presents First Data from MB-106’s Multicenter Trial; Anticipated Enrollment of YTB323’s SLE Trial Increased- August 2023 Recap (Blast 2/2)

In August 2023, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. Celltelligence decided to publish a two-part series discussing the news and providing insights about their importance in the cell therapy space. In this second summary, the following topics are covered:

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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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