Category Archives: Autologous

Autolus’s Obe-cel US Regulatory Filing Planned for Early 2023; BMS Invests in Clade Therapeutics; New Gracell CD19 UCAR-T Ph1 Trial in R/R B-ALL and B-NHL Posted; Autolus Q3 2021 Earnings Call Summary

On Wednesday, November 3, Autolus held their Q3 2021 earnings call (press release / presentation) highlighting updates from obe-cel (CD19 CAR-T; formerly AUTO1) and their next-generation candidates. On the same day, Clade Therapeutics announced (press release) that they have secured $87M in Series A financing with participation from BMS. Finally, a new Gracell early Ph1 trial evaluating an allogeneic CD19 UCAR-T in r/r B-ALL and B-NHL was observed on CT.gov.

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Thoughts on Cilta-cel US Delay

Yesterday’s PDUFA delay for JNJ/Legend’s BCMA CAR-T product cilta-cel was unexpected (see previous insight), and it brings up some potentially relevant questions. Below, Celltelligence discusses if the benefit to BMS is as obvious as one may think.

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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 US Delay to February 28, 2022

After market close today, November 1, 2021, Legend announced the PDUFA delay for cilta-cel to February 28, 2022, a delay of 3 months from the original action date of November 29, 2021. The news comes on the heels of bullish commentary from Legend’s October 18 R&D day (see previous insight) and JNJ’s Q3 2021 earnings on October 21 (see previous insight).

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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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Yescarta’s Sales Decline; Gilead’s (Kite) New Manufacturing Facility in Maryland to Be Operational By Mid-2022; Health Canada Approves Tecartus in MCL; Gilead’s Q3 2021 Earnings Call Summary

On Thursday, October 28, Gilead held their Q3 2021 earnings call (press release / presentation) highlighting Yescarta’s (CD19 CAR-T) sales decline and the anticipated opening of their new manufacturing facility in Frederick County, Maryland. On the same day, Gilead announced (press release) that Health Canada has approved Tecartus (CD19 CAR-T) in r/r mantle cell lymphoma (MCL), based on results from the Ph2 ZUMA-2 trial. Below, Celltelligence provides insights on the potential impact of increased ATC competition on Yescarta’s Q3 sales revenue, while outlining likely US and EU approval timelines for Yescarta in 2L r/r DLBCL and Tecartus in r/r adult ALL. Finally, Celltelligence discusses Tecartus’s approval and reimbursement in Canada.

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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’s Breyanzi and Abecma Sales Increase; Could Abecma’s Continued Viral Vector Shortage Favor Cilta-cel’s Upcoming Launch? No Updates on GSK’s Cell Therapy Assets; BMS and GSK Q3 2021 Earnings Call Summaries

On Wednesday, October 27, BMS held their Q3 2021 earnings presentation (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) continued revenue growth. Furthermore, management commented that Abecma’s vector supply issues may not be fully resolved before H2 2022. On the same day, GSK presented their Q3 2021 financial results (press release / presentation). However, the company did not provide any updates on their cell therapy assets in development.

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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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Novartis Receives Priority Review for Kymriah in R/R FL

On Wednesday, October 27, Novartis announced (press release) that the FDA has granted Kymriah (CD19 CAR-T) Priority Review in r/r FL. Below, Celltelligence provides insights on Kymriah’s anticipated US approval in ≥3L r/r FL.

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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’s Sales Continue to Decline; Novartis Files Kymriah for R/R FL in the US and EU; Why is Novartis Prioritizing YTB323 in 2L DLBCL? Novartis Q3 2021 Earnings Call Summary

On Tuesday, October 26, Novartis held their Q3 2021 earnings presentation (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) continued sales decline and the US + EU regulatory submissions for Kymriah in r/r FL. Of note, management announced that in 2022, they intend to initiate a registrational trial for YTB323 (next-gen CD19 CAR-T) in 2L r/r DLBCL. Below, Celltelligence provides insights on Kymriah’s Q3 2021 sales revenue, while discussing likely US and EU approval timelines for Kymriah in r/r FL. Finally, Celltelligence outlines why declining Kymriah revenue doesn’t matter for a committed Novartis.

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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 TCR2 Tx’s Collaboration With BMS

On Monday, October 25, TCR2 Therapeutics announced (press release) a clinical trial collaboration with BMS to evaluate gavo-cel (TC-210; mesothelin TRuC-T) with Opdivo (nivolumab; PD1 inhibitor) ± Yervoy (ipilimumab; CTLA-4 inhibitor) in a Ph2 trial for refractory mesothelin-expressing solid tumors. Below, Celltelligence provides insights on why TCR2 Tx may have chosen BMS’s checkpoint inhibitors and how BMS could leverage this collaboration for their own solid tumor programs.

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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 Prepares for Cilta-cel’s Upcoming Approval; Could JNJ’s / Legend’s New Patient-Focused Digital Platform and Sales Force Strategy Position Cilta-cel for a Successful Launch?

On Thursday, October 21, FiercePharma published an article (publication) discussing cilta-cel’s launch strategy with Serge Messerlian, Janssen’s US Oncology President. Messerlian commented on JNJ’s / Legend’s plan to develop a digital platform for cilta-cel (BCMA CAR-T) while confirming that cilta-cel and Darzalex (JNJ’s CD38 antibody for r/r MM; daratumumab) will have separate sales teams. Below, Celltelligence provides insights on how JNJ / Legend could leverage Darzalex’s patient-focused digital platform and sales force team to increase patient referrals for cilta-cel upon 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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TCR2 Tx Pivots Away from Liquid Tumors; Will Enhanced TRuC-Ts Improve Efficacy in Solid Tumors? TCR2 Tx Explores New Targets and Allogeneic Candidates; TCR2 Tx’s R&D Day

On Wednesday, October 20, TCR2 Therapeutics held an R&D Day (press release / presentation) highlighting the reprioritization of their pipeline to solely focus on solid tumors. Additionally, management reported updated safety data from gavo-cel’s (TC-210; mesothelin TRuC-T) Ph1/2 trial and additional details on the design of the Ph2 portion. TCR2 Tx presented their strategy for TRuC-T enhancements, new targets in development, and their allogeneic program. Finally, on Tuesday, October 19, a change in TCR2 Tx’s website and logo was observed.

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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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