Category Archives: Allogeneic

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 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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CB-012’s IND Cleared by the FDA; Caribou Joins the AML Race

On Wednesday, October 18, Caribou announced CB-012’s (allogeneic CLL-1 CAR-T; PD-1 KO + B2M KO + TCR KO + B2M-HLA-E KI) IND clearance by the FDA to start a trial in 2-4L AML. Below, Celltelligence provides insights on the trial design while discussing the potential advantages of Caribou’s AML program over its competitors.

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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 Terminates 2 Arms in ZUMA-25 Trial; UPenn Starts Trial in Prostate Cancer with Former Tmunity Asset; A2 Bio Publishes New Study in Solid Tumors; Cartesian to Initiate Trial in SLE

In the past few weeks, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. In this blast, Celltelligence will cover the following topics: 

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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AMT Designation Program and CDRP Pilot to Facilitate CMC Development of Products; ASGCT 2023 Policy Summit Analysis (Blast 2/2)

ASGCT 2023 Policy Summit Analysis 2: CMC information plays a fundamental role in the development and regulation of cell and gene therapies (CGTs), which has motivated the generation of new policies to facilitate and expedite its evaluation. Celltelligence is publishing a two-part series discussing the strategies the FDA is following to keep up with innovation in the CGT field and providing insights about their relevance in the cell therapy space. In this second blast, 2 new non-CGT-specific FDA policy initiatives focused on addressing CMC challenges are covered:

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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The Office of Therapeutic Products Bets on Communication; New Cell and Gene Therapy Access Model to Be Tested; ASGCT 2023 Policy Summit Analysis (Blast 1/2)

ASGCT 2023 Policy Summit Analysis 1: Cell and gene therapies (CGTs) have emerged as novel treatment options with unique characteristics that differ from previously approved therapies, which has motivated the generation of new regulatory processes and policies. The ASGCT 2023 Policy Summit delved into some of the strategies the FDA is following to keep up with innovation in the CGT field. Celltelligence will publish a two-part series discussing these new approaches and providing insights about their relevance in the cell therapy space. In this first blast, the following topics are covered:  

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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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:

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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You May Have Missed: CARsgen Partners with Moderna; AZ to Collaborate in the Development of a New CAR-T in Solid Tumors; Gilead to Evaluate Novel Dual CAR-T; Poseida and Roche Publish P-CD19CD20-ALLO1’s New Trial; Germany’s G-BA Completes Carvykti’s Reimbursement – August 2023 Recap (Blast 1/2)

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

About The Author

The Celltelligence Team

|
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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Precision and Imugene Agree on Terms for the Transfer of Azer-cel; Precision to Deprioritize its Cell Therapy Franchise

On Tuesday, August 15, Precision Biosciences announced (press release) a strategic transaction with Imugene for the exclusive WW licensing of azer-cel (PBCAR0191; allogeneic CD19 CAR-T) in oncology, which also included option to develop up to 3 other cancer programs. Additionally, Imugene disclosed (press release) its intention to continue azer-cel’s Ph1/2a trial in ≥3L NHL and r/r ALL, while planning the initiation of a potentially registrational trial in 2024. Below, Celltelligence provides insights on azer-cel’s transaction agreement, while analyzing the possible therapeutic potential of the combination of the licensed CD19 CAR-T with Imugene’s proprietary onCARlytics platform.

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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GC012F’s US Trial Initiated; GC012F to Be Evaluated in SLE in the US; Pipeline Reprioritization; Gracell’s Q2 2023 Earnings Call Summary

On Monday, August 14, Gracell held its Q2 2023 earnings call (press release) highlighting the initiation of GC012F’s (BCMA x CD19 FasTCAR-T) Ph1b/2 trial for ≥4L MM in the US, while disclosing the company’s intention to submit an IND to the FDA for the evaluation of GC012F for SLE. Additionally, Gracell announced a reprioritization of its pipeline and confirmed the closing of the private placement financing reported on August 7. Below, Celltelligence provides insights on GC012F’s clinical milestones in MM, while analyzing GC012F options in SLE and the company’s reprioritized pipeline.

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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