Tag Archives: Autologous

Celgene’s CVR Payment Vanishes As Liso-cel Is Not Approved Before Dec 31, 2020

As of January 1, 2021, the FDA has not yet approved BMS’s CD19 CAR-T liso-cel, and BMS’s press release today confirmed the termination of the Celgene CVR. Below, Celltelligence provides insights on the potential for litigation following liso-cel’s missed approval deadline for Celgene’s CVR shareholders.

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Cilta-cel Submitted in US; Could Approval be Earlier than August 2021?

On Monday, December 21, JNJ announced (press release) the US rolling submission of cilta-cel’s (BCMA CAR-T) BLA in ≥4L r/r Multiple Myeloma (MM). Below, Celltelligence provides insights on cilta-cel’s potential approval date and how this could reduce ide-cel’s first-to-market advantage.

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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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Could Cilta-cel Become the BCMA CAR-T of Choice in 2021? ASH Day 3 Legend Investor Event

On the third day of ASH 2020, Legend held an investor event to discuss the recent data presented at ASH 2020 from the Ph1b/2 CARTITUDE-1 study. Below, Celltelligence provides a summary of the call, JNJ’s / Legend’s possible messaging for cilta-cel, and regulatory updates in the US and EU.

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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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AUTO3 Outpatient Data in the Ph1/2 ALEXANDER Study; Updated Results for Liso-cel in the TRANSCEND CLL 004 Trial; ZUMA-5 Primary Analysis and Re-treatment; ASH Day 3

On the third day of ASH 2020, four key clinical updates were presented from Autolus, BMS and Gilead. Below, Celltelligence provides insights and context for each presentation.

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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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Kymriah Demonstrates a Favorable Safety Profile in FL; Updated Results for AUTO1’s Ph1 ALLCAR19 Trial in ALL and iNHL; Initial Data from Cellectis’s UCART22 Ph1 BALLI-01 Study; ASH Day 1 Encore

On the first day of ASH 2020, three key clinical updates were presented from Novartis, Autolus, and Cellectis. Below, Celltelligence provides insights and context for each presentation.

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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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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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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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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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AUTO1 and AUTO3 Clinical Updates to be Presented at ASH 2020; AUTO3 Pivotal Trial Likely in H1 2021; Autolus Q3 2020 Earnings Call Summary

On Thursday, November 5, Autolus held their Q3 2020 earnings call (press release/ presentation). Management highlighted that updated data from the AUTO1 Ph1 ALLCAR19 and AUTO3 Ph1/2 ALEXANDER studies will be presented at ASH 2020. Additionally, Autolus noted that AUTO3 may move to a pivotal trial in H1 2021. Below, Celltelligence provides insights into Autolus’s clinical updates at ASH 2020 and how AUTO3 could disrupt the increasingly crowded ≥3L DLBCL 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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No FDA Updates for Liso-cel or Ide-cel; New GPRC5D CAR-T in MM; BMS Q3 2020 Earnings Call Summary

On Thursday, November 5, BMS held their Q3 2020 results (press release / presentation). No updates were provided for liso-cel’s or ide-cel’s regulatory approval. Of note, BMS added a new CAR-T targeting GPRC5D in ≥4L r/r multiple myeloma (MM) to their portfolio. Below, Celltelligence provides thoughts on liso-cel’s anticipated PDUFA November date and how a GPRC5D CAR-T could disrupt the MM 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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