Category Archives: Topics

Interim Results from PBCAR0191’s Ph1/2a Trial; Updated Clinical Strategies to Improve Response; New Details Disclosed for PBCAR19B Stealth CAR-T; Precision’s Pre-ASH Investor Call Summary

On Friday, December 4, Precision reported interim results from their PBCAR0191 Ph1/2a trial, an allogeneic CD19 CAR-T in r/r NHL and ALL, and held an investor webcast (press release / presentation). Management confirmed that PBCAR19B, a next generation CD19 “stealth cell” CAR-T, is expected to enroll patients in H1 2021. Below, Celltelligence provides insights into PBCAR0191’s lymphodepletion regimens and how their approach differs from key allogeneic competitor Allogene.

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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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A New Ph1 Trial for Precision’s CD19 Allogeneic CAR-T PBCAR19B; Could PBCAR19B Knock Down B2M Expression to Enhance Persistence?

On Wednesday, December 2, a new Precision Biosciences-sponsored Ph1 trial has been detected on CT.gov for the allogeneic CD19 CAR-T, PBCAR19B, in ≥3L r/r NHL. Below, Celltelligence provides insights on this new trial and how PBCAR19B could use Precision’s B2M “stealth” vector to increase allogeneic CAR-T persistence, while avoiding NK cell activation.

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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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UPDATED: Novartis on Track to File Kymriah in R/R FL and 2L DLBCL in 2021; Meet the Management Investor Call Summary

New content: The Celltelligence team has included and updated its CAR-T indications table for estimated approvals and submissions (see below for download) and made a small clarification that BELINDA trial results for Kymriah are expected at ASH 2021.

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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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Will FDA Virtually Inspect for Liso-cel US Approval? Celgene CVR Hangs in the Balance

On Wednesday, November 18, 2020, BMS stated at the Wolfe Research Healthcare Conference (transcript available from Seeking Alpha) that they are open to the possibility of a FDA virtual inspection for liso-cel’s Texas facility. As a reminder, the FDA missed their anticipated PDUFA date for liso-cel (Nov 16, 2020), due to an incomplete site inspection. Below, Celltelligence provides thoughts on the possible scenarios for the Texas facility’s inspection and how this may impact BMS’s CVR milestone.

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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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FDA Lifts Clinical Hold for Cellectis’s UCARTCS1 Ph1 MELANI-01 Trial; No Update on Protocol Changes

On Tuesday, November 17, Cellectis announced (press release) that the FDA has lifted the clinical hold on their UCARTCS1 (CS1 allogeneic CAR-T) Ph1 MELANI-01 trial in r/r MM. Below, Celltelligence provides insights on the trial’s FDA mandated clinical hold and possible protocol changes.

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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 Liso-cel’s Incomplete FDA Review; PDUFA Analysis may have Possible Implications for CAR-T CMOs and Manufacturing Partnerships

Yesterday, November 16, 2020, BMS announced (press release) that the FDA informed the company that its BLA review for liso-cel (CD19 CAR-T) in ≥3L r/r LBCL will not be completed by the PDUFA action date of November 16, 2020. Management confirmed that the FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Below, Celltelligence provides thoughts on the missed PDUFA action date, how liso-cel’s progress compares with other CAR-T PDUFA dates, and the risk associated with using a CMO (clinical manufacturing organization) for commercially manufacturing CAR-T products.

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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 ASH 2020 Clinical Updates; Global Regulatory Filings Remain on Track; Allogeneic BCMA CAR-T Enters into Ph1 Trial; Legend’s Q3 2020 Earnings Call Summary

On Monday, November 16, Legend Biotech released their Q3 2020 earnings and financial results (press release), highlighting upcoming ASH 2020 presentations for their BCMA CAR-T cilta-cel (Ph1b/2 CARTITUDE-1 and Ph2 LEGEND-2 trials). Furthermore, management confirmed that cilta-cel’s submission to the FDA and EMA are anticipated by YE 2020 and early 2021, respectively. Finally, Legend commented that in 2021 they anticipate to file cilta-cel with the Chinese NMPA. Below, Celltelligence provides insights on cilta-cel’s global regulatory updates and the potential impact to BMS’s BCMA CAR-T ide-cel.

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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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Ziopharm’s TCR-T Program at the NCI Continues to Face Delays; MD Anderson Hotspot TCR-T IND Filing on Track for 2021; Q3 2020 Earnings Call Summary

On Thursday, November 5, Ziopharm held their Q3 2020 earnings call (press release / presentation) highlighting that their TCR-T and RPM CAR-T programs remain on track. Of note, management commented that in Q1 2021 they anticipate filing an IND application for their MD Anderson, library TCR-T program. Below, Celltelligence provides insights on Ziopharm’s TCR-T and CAR-T programs, as well as the potential risk associated with further clinical delays.

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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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UCART22 and UCART123 Clinical Updates to be Presented at ASH 2020; UCARTCS1 Remains on Clinical Hold; Cellectis Q3 2020 Earnings Call Summary

On Friday, November 6, Cellectis held their Q3 2020 earnings call (press release). No significant updates were provided about the FDA hold for the Ph1 MELANI-01 trial in r/r MM. Furthermore, management stated that preliminary data from the UCART22 Ph1 BALLI-01 study (in r/r ALL) and UCART123 Ph1 AMELI-01 (in r/r AML) trial will be presented at ASH 2020. Below, Celltelligence provides thoughts on Cellectis’s CAR-T programs and the possible impact of alemtuzumab lymphodepletion.

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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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Legend Appoints a New CEO and Chairperson; New Ph1 Pipeline Updates Including an Allogeneic BCMA CAR-T

On Monday, November 9, Legend announced (press release) the appointment of Ms. Ye (Sally) Wang as Chairwoman of the Board of Directors and Dr. Ying Huang (previous CFO) as Chief Executive Officer. Of note, Legend added three Ph1 trials to their clinical pipeline, including an allogeneic BCMA CAR-T. Below, Celltelligence provides additional context for the new leadership appointments and how Legend’s allogeneic BCMA CAR-T could impact the multiple myeloma landscape.

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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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