Tag Archives: CAR-T

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 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-715 Ph1 UNIVERSAL Initial Data to be Presented at ASH 2020; Redosing Strategy Confirmed for ALLO-501 Ph1 ALPHA Trial; Allogene Q3 2020 Earnings Call Summary

On Wednesday, November 4, Allogene held their Q3 2020 earnings call (press release). Allogene highlighted data from their ALLO-715 Ph1 UNIVERSAL trial in ≥4L r/r multiple myeloma (MM) due to be presented at ASH 2020. Moreover, management confirmed the redosing strategy for their ALLO-501 (CD19 CAR-T) Ph1 ALPHA trial study. Below, Celltelligence provides insights into the significance of the UNIVERSAL data and how Allogene may approach redosing for their other clinical 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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Continued Kymriah Sales Growth Despite COVID-19; Kymriah’s LCM Initiatives Remain on Track; Q3 2020 Earnings Call Summary

On Tuesday, October 27, Novartis held their Q3 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales grew +51% WW YoY, and +3% WW QoQ. Below, Celltelligence provides thoughts on Kymriah’s reduced growth rate and potential implications for Yescarta’s Q3 2020 results.

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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 Ziopharm’s TCR-T Programs; Ziopharm at Jefferies Cell Therapy Summit Call Summary

On Monday, October 5, Ziopharm participated in the Jefferies Cell Therapy Summit (press release). Management highlighted advances to their library TCR-T and personalized TCR-T programs. Below, Celltelligence provides thoughts on the potential market opportunities for Ziopharm’s TCR-T and CD19 CAR-T therapies.

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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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Allogene and MD Anderson Announce a 5-Year Collaboration to Develop Allogeneic CAR-Ts

On Thursday, October 15, Allogene announced (press release) a five-year collaboration with the MD Anderson Cancer Center for the preclinical and clinical development of Allogene’s AlloCAR-T candidates. Below, Celltelligence provides insights on the significance of this collaboration for Allogene’s clinical pipeline.

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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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CHMP Adopts Positive Opinion for Gilead’s Tecartus in r/r Mantle Cell Lymphoma

On Friday, October 16, Gilead announced (press release) that the CHMP has adopted a positive opinion for Tecartus (brexucabtagene autoleucel, formerly KTE-X19) in ≥3L r/r mantle cell lymphoma (MCL). If approved by the EC, Tecartus would become the first and only CAR-T treatment approved for r/r MCL in Europe. Below, Celltelligence provides thoughts on Tecartus’s positive CHMP opinion and the likelihood of Gilead onboarding EU centers within 30 days of EC approval.

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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 BioSciences Wins Patent Challenge Relating to CAR-T Engineering

On Thursday, October 15, Precision BioSciences announced (press release) that the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) has ruled in favor of Precision. The ruling resulted from two patent interference proceedings that challenged nine U.S. patents owned by Precision. Below, Celltelligence provides brief thoughts on the patent win for Precision.

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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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JNJ-4528 US Filing Anticipated in Q4 2020; JNJ Q3 2020 Earnings Summary

On Tuesday, October 13, JNJ held their Q3 2020 earnings call (press release / presentation). Management reported a +13.3% WW sales growth for their oncology division, driven by their multiple myeloma product Darzalex (US +46%; WW +43.8%). Of note, JNJ confirmed that JNJ-4528 (BCMA CAR-T) is anticipated to be filed with the FDA in Q4 2020. Below, Celltelligence provides insights on a JNJ-4528 approval in 2021 and the potential impact on ide-cel (BMS) sales in the US and EU.

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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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Ziopharm´s RPM Allogeneic CD19 CAR-T Trial Started Enrollment; Q2 2020 Earnings Summary

On Thursday, August 6, Ziopharm held their Q2 2020 earnings call (press release / presentation), highlighting the initiation of their allogeneic CD19 CAR-T Ph1 trial post allo-SCT. Management confirmed that the IND submission in Greater China (China and Taiwan) for autologous CD19 CAR-Ts is anticipated by YE 2020. In Q1 2021, Ziopharm expects to submit CMC data for their personalized and library TCR-T IND application. Below, Celltelligence provides thoughts on Ziopharm’s global CD19 CAR-T initiatives and the potential challenges and opportunities for their TCR-T programs.

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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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Thoughts on Gilead’s sBLA Submission for Yescarta in r/r iNHL (ZUMA-5)

On Friday, September 4, Gilead announced (press release) the submission of an sBLA to the FDA for Yescarta in r/r ≥3L iNHL (follicular lymphoma and marginal zone lymphoma). The sBLA application is based upon positive results from the Ph2 ZUMA-5 trial. Below, Celltelligence provides insights on Yescarta’s sBLA timeline and the potential impact from competitors Novartis (Kymriah) and BMS (liso-cel).

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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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