Category Archives: Allogeneic

Caribou to Share FDA’s Feedback on Potential CB-010 Pivotal Trial by YE 2023; Caribou’s Q2 2023 Earnings Summary

On Tuesday, August 8, Caribou released their Q2 2023 results and business updates (press release) confirming plans to meet the FDA to discuss a potential pivotal trial for CB-010 (allogeneic CD19 CAR-T) in 2L LBCL and its hopes to share the FDA’s feedback by YE 2023. Moreover, the company highlighted the recent Pfizer investment in Caribou’s CB-011 (allogeneic BCMA CAR-T) program. Below, Celltelligence provides insights on how Caribou’s plans to run a potential trial in 2L LBCL may evolve and compares them to those of its main competitors.

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Thoughts on Astellas’s Strategic Investment in Poseida; Astellas Gains Rights over P-MUC1C-ALLO1 Program; First Patient in P-CD19CD20-ALLO1 Trial to Be Dosed in Early 2024; Gracell Announces Private Investment

On Monday, August 7, Poseida and Astellas announced (press release) a strategic investment to support the advancement of Poseida’s cell therapy assets in solid tumors with Astellas receiving the right of exclusive negotiation and first refusal to license P-MUC1C-ALLO1 (allogeneic MUC1C CAR-T). Additionally, Poseida provided (press release) a business update on its allogeneic CAR-T programs and Gracell reported (press release) up to $150M in private placement financing by a syndicate of premier healthcare investors. Below, Celltelligence provides insights on Astellas’s interest in allogeneic cell therapies, while discussing how Poseida and Gracell could benefit from these investments.

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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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Cellectis to Provide Updates of All Clinical Programs in 2023; Company to Advance FAP-Targeting UCART Program in Solid Tumors into the Clinic; Precision Actively Seeking Partners to Advance Azer-cel and PBCAR19B; Cellectis’s and Precision’s Q2 2023 Earnings Call Summary

On Friday, August 4, Cellectis held its Q2 2023 earnings call (press release) highlighting anticipated updates for the clinical programs of UCART22 (allogeneic CD22 CAR-T), UCART20x22 (allogeneic CD20xCD22 CAR-T) and UCART123 (allogeneic CD123 CAR-T) later in 2023. On the same day, Precision reported its Q2 2023 earnings call (press release) reiterating the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T), and the active discussions with potential partners for the development of its cell therapy assets. Below, Celltelligence provides insights on Cellectis’s updates of its UCAR-T assets, while discussing Precision’s active search for partnerships and azer-cel’s potential in LBCL.

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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’s BLA Submission on Track for YE 2023; New Obe-cel Ph1 Trial to Start for SLE; Two Assets Added to the Pipeline; Autolus’s Q2 2023 Earnings Call Summary

On Thursday, August 3, Autolus held its Q2 2023 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) BLA submission in r/r ALL is still expected by YE 2023. Of note, the company plans to start a new obe-cel trial in SLE in 2024 and added two new assets to its pipeline, including an allogeneic version of obe-cel. Below, Celltelligence provides insights on obe-cel’s pathway towards commercialization, while discussing its entry into the autoimmune 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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ALLO-501A’s ALPHA2 Trial to Start Enrollment Ex-US; EXPAND Continues Recruiting Slowly; ALPHA3 Trial Redefined; Allogene’s Q2 2023 Earnings Call Summary

On Wednesday, August 2, Allogene held its Q2 2023 earnings call (press release) highlighting the progress of ALLO-501A’s (allogeneic CD19 CAR-T) Ph1/2 ALPHA2 trial in ≥3L LBCL and the EMA Clinical Trial Application approval to expand the study to Europe. Below, Celltelligence provides insights on ALPHA2 and Ph2 EXPAND trial timelines, while discussing the company’s potential strategy for the Ph3 ALPHA3 trial in LBCL.

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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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Precision Receives Feedback from the FDA on Azer-cel’s Registrational Pathway

On Thursday, July 27, Precision Biosciences announced (press release) the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T). Moreover, the company disclosed discussions with multiple potential strategic partners for the development of its cell therapy assets. Below, Celltelligence provides insights on azer-cel’s potential in LBCL, while comparing the asset with its main allogeneic competitors.

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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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Caribou Shares Positive Data from ANTLER Trial in B-NHL; Pfizer Invests in Caribou’s BCMA-targeting Cell Therapies

On Thursday, July 13, Caribou held a virtual event to report follow-up data from CB-010’s (allogeneic CD19 CAR-T) Ph1 ANTLER trial for patients with ≥2L B-NHL (press release / presentation). Notably, the news came a week after Pfizer made a $25M equity investment in Caribou to advance CB-011 (allogeneic BCMA CAR-T) program (press release, Jul 6, 2023). Below, Celltelligence provides insights on CB-010’s clinical results and Caribou’s plans to discuss with the FDA the initiation of a pivotal trial in 2L LBCL, while discussing Pfizer’s investment in Caribou’s allogeneic asset for MM.

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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 FDA Clears Poseida’s P-CD19CD20-ALLO1 IND in B-Cell Malignancies

On Wednesday, July 5, Poseida announced (press release) that the FDA has approved the IND for P-CD19CD20-ALLO1 (allogeneic CD19 x CD20 dual CAR-T) in B-cell malignancies. Below, Celltelligence provides insights on P-CD19CD20-ALLO1’s IND clearance while discussing the potential competition that P-CD19CD20-ALLO1 could face.

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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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GC012F Demonstrates a Promising Profile in ≥3L DLBCL Patients; ALYCANTE Trial Confirms Yescarta’s Excellent Efficacy in TI 2L LBCL Patients; NKX019 Shows Potential in NHL Patients; EHA 2023 Analysis 3

EHA 2023 Analysis 3: Gracell and Nkarta presented clinical updates from their programs in B-cell malignancies. Moreover, the French Lymphoma Academic Research Organisation (LYSARC) provided the final results of Yescarta’s (Gilead’s (Kite) CD19 CAR-T) ALYCANTE trial. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

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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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Promising Preliminary GC007g Efficacy Data in B-ALL Patients that Relapsed Post-Allo-HSCT; Prior CD19-Targeting Treatments Could Affect Tecartus Efficacy in R/R ALL; UCART22 Shows 50% CR in r/r B-ALL Patients Failing Previous CD19 CAR-T Therapy; EHA 2023 Analysis 1

EHA 2023 Analysis 1: Gracell, Gilead (Kite), and Cellectis presented clinical updates from their programs in B-ALL. Below, Celltelligence provides insights and context for key selected presentations. 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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