Category Archives: CAR-T

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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Precision Biosciences Highlights First Patient Dosed with BCMA CAR-T PBCAR269A; PBCAR0191 Clinical Updates Delayed to YE; Q2 2020 Earnings Summary

On Thursday, August 13, Precision Biosciences released their Q2 2020 financial results (press release). While no new data was presented, Precision highlighted that the first patient was dosed with PBCAR269A (an allogeneic BCMA CAR-T) for the Ph1/2 trial in r/r MM. Moreover, management confirmed that interim data from the PBCAR0191 (an allogeneic CD19 CAR-T) Ph1 study in ≥3L r/r NHL and r/r ALL will be delayed due to the COVID-19 pandemic. Below, Celltelligence provides thoughts on key competitors Precision and Allogene’s position within the allogeneic BCMA CAR-T setting and the possibility for a PBCAR0191 presentation at ASH 2020.

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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 Biotech Highlights FDA Filing of Cilta-Cel by YE 2020; Q2 2020 Earnings Summary

On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.

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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 Cellectis’s CAR-T Program; Potential UCARTCS1 Protocol Changes; Q2 2020 Earnings Call

On Wednesday, August 5, Cellectis held their Q2 2020 conference call (press release). As expected, the company discussed the recent FDA hold on the UCARTCS1 Ph1 MELANI-01 trial in r/r MM. Management also stated that interim data will be presented for either UCART22 or UCART123 in Q4 2020, and that the Paris and Raleigh manufacturing sites remain on track to open later in 2020 and in 2021, respectively. Below, Celltelligence provides key takeaways from the call, and thoughts on Cellectis’s CAR-T program, particularly around the anticipated next steps for UCARTCS1.

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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 Autolus’s CAR-T Program; Q2 2020 Earnings Call

On Thursday, August 6, Autolus held their Q2 2020 earnings call (press release/ presentation). The company announced that updated data from the AUTO3 Ph1/2 ALEXANDER study in ≥3L DLBCL will be presented at ESMO on September 18, 2020. In addition, management stated that they have experienced minimal interruption to their clinical program from COVID-19, except for the Ph1 AUTO4 trial (≥2L r/r TRBC1+ TCL) where data readout has been delayed from Q4 2020 to H1 2021. Below, Celltelligence provides key takeaways from the call, and thoughts on how Autolus’s CAR-T program, particularly in ALL (AUTO1) and DLBCL (AUTO3), may be able to compete with CAR-T leaders Novartis, Gilead, and BMS.

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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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Gilead Highlights No Impact of COVID-19 on Yescarta Sales; Two New LCM Initiatives for Yescarta; Q2 2020 Earnings Call Summary

On Thursday, July 30, Gilead held their Q2 2020 earnings call (press release / financial report / presentation). The company highlighted resilient Yescarta sales despite the COVID-19 pandemic, growing 11% QoQ and 37% YoY WW. Of note, Gilead highlighted the recent approval of Tecartus and ongoing LCM efforts for both approved CAR-T’s. Below Celltelligence highlights key LCM initiatives for 2021 and the significance of a synergistic authorized treatment center (ATC) onboarding protocol for Gilead.

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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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bluebird bio Highlights Ide-cel Resubmission; Q2 2020 Earnings Call

On Wednesday, August 5, bluebird bio released their Q2 2020 financial results (press release). No new data was reported; however, the company highlighted the successful resubmission of their ide-cel BLA application. Below, Celltelligence provides insights on ide-cel’s potential approval date in the EU and a possible alternative messaging strategy for the CAR-T in earlier lines of therapy.

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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 Allogene’s AlloCAR Program; Q2 2020 Earnings Call Summary

On Wednesday, August 5, Allogene held their Q2 2020 conference call (press release / company presentation). The company highlighted presented ASCO data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study in ≥3L NHL (DLBCL or FL) (Sattva Neelapu et al, May 2020). Management confirmed that the pivotal Ph1/2 ALPHA-2 study of ALLO-501A is underway, with no reported DLTs in the dose level 1 (DL1) cohort. Below, Celltelligence provides key takeaways about Allogene’s CAR-T clinical program, and thoughts on potential hurdles the company may face re-treating patients that have already received Gilead and Novartis’s CAR-Ts in earlier lines of therapy.

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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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BMS Highlights Ide-cel FDA Re-submission; Q2 2020 Earnings Call

On Thursday, August 6, BMS held their Q2 2020 results (press release / presentation). The company briefly discussed their CAR-T program, highlighting that the BLA for ide-cel in ≥4L RRMM has been re-submitted. In addition, management stated that they look forward to the November PDUFA date for liso-cel in ≥3L DLBCL. Below, Celltelligence provides thoughts on BMS’s two leading CAR-Ts, both of which have experienced delays to their FDA reviews.

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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 Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

On Friday, July 24, Gilead announced (press release) FDA accelerated approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional 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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