Category Archives: Topics

ALLO-501A’s ALPHA2 Trial Expands to Europe and Australia; EXPAND Study to Open Enrollment in Europe; ALLO-316’s Initial Results Postponed to Early 2024; Allogene’s Q3 2023 Earnings Call Summary

On Thursday, November 2, Allogene held its Q3 2023 earnings call (press release), highlighting the expansion of the Ph1/2 ALPHA2 trial, evaluating ALLO-501A (allogeneic CD19 CAR-T) in ≥3L LBCL, into Europe and Australia and the opening of recruitment in the Ph2 EXPAND trial, studying the use of ALLO-647 (anti-CD52 mAb) as part of the lymphodepletion regimen, in Europe. Additionally, the company delayed the data readout from ALLO-316’s (allogeneic CD70 CAR-T) Ph1 TRAVERSE trial for r/r ccRCC to early 2024 and noted the upcoming presentation of 2 analyses from the ALPHA2 study at ASH 2023. Below, Celltelligence provides insights on Allogene’s difficulties in the onboarding process for the EXPAND study, while discussing the potential development of the Ph3 ALPHA3 trial in earlier line LBCL and the initial interest of the company in non-oncology indications. 

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Adaptimmune Presents Positive Lete-cel and Afami-cel Data in SS and MRCLS

On Tuesday, October 31, Adaptimmune updated its corporate deck and published 2 press releases announcing clinical updates from lete-cel (NY-ESO1 TCR-T) and afami-cel (MAGE-A4 SPEAR-T) to be presented at CTOS 2023 (November 1-4):

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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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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

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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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Kite to Collaborate with Epic Bio to Develop New Therapies for Cancer

On Tuesday, October 31, Gilead (Kite) announced a research collaboration and license agreement with Epicrispr Biotechnologies (Epic Bio) for the use of Epic Bio’s proprietary gene regulation platform to develop next-generation cancer cell therapies (press release). Below, Celltelligence provides insights on how Gilead could leverage Epic Bio’s platform to develop better cell therapies for hematological diseases.

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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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AstraZeneca and Cellectis Enter into Collaboration to Develop up to 10 Novel Cell and Gene Therapy Candidates Leveraging Cellectis’s Gene Editing Technologies and Manufacturing Capabilities

On Wednesday, November 1, AstraZeneca (press release) and Cellectis (press release) announced they entered into a strategic collaboration and investment agreement for the development of up to 10 novel cell and gene therapy candidate products in areas of high unmet need, including oncology, immunology, and rare diseases. Below, Celltelligence provides insights on the partnership, analyzes Cellectis’s TALEN-based gene-editing platform, and discusses how both companies could benefit from the collaboration.

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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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An ARI-0003 Trial to Be Initiated by Hospital Clinic; Mustang’s MB-109 Receives IND Clearance from the FDA

On Tuesday, October 24, a new early Ph1 CARTD-BG-1 trial evaluating ARI-0003 (BCMA x CD19 CAR-T), an academic CAR-T developed by the Hospital Clinic of Barcelona, Spain, in r/r B-cell aggressive lymphoma was posted on CT.gov. Moreover, on Thursday, October 26, Mustang Bio announced FDA acceptance of the IND application to evaluate MB-109 [MB‐101 (IL13Rα2 CAR-T) + MB-108 (HSV1 oncolytic virus)] in recurrent glioblastoma (GBM) and high-grade astrocytoma (press release). Below, Celltelligence provides insights on both cell therapies, discussing their potential advantages.

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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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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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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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Kymriah’s Revenue Continues to Decrease; No Updates on Cell Therapy Programs; Novartis’s Q3 2023 Earnings Call Summary

On Tuesday, October 24, Novartis held its Q3 earnings call (press release / presentation) reporting $124M in Kymriah (CD19 CAR-T) WW sales, while the company did not provide any update on its cell therapy programs. Below, Celltelligence provides insights on Kymriah’s Q3 2023 revenue while discussing changes observed in the company’s trial evaluating YTB323 in systemic lupus erythematosus (SLE).

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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ADP-A2M4CD8 Maintains its Efficacy in MAGE-A4+ Solid Tumors; BNT211 Continues to Impress in Solid Tumors; IM96 Demonstrates Excellent Safety Profile but Modest Preliminary Efficacy in mCRC; ESMO 2023 Analysis 2

ESMO 2023 Analysis 2: Adaptimmune, BioNTech, and Immunochina presented clinical updates from their CAR-T programs in solid tumors. Below, Celltelligence provides insights and context on key selected presentations: 

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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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