Tag Archives: BMS

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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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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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 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 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 Bets on Digital Health Coaching Following CAR-T Treatment to Improve Quality of Life Outcomes

On Friday, October 1, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with BMS and the MD Anderson Cancer Center appearing as collaborators. Below, Celltelligence provides insights on BMS’s use of digital tools as a potential strategy to facilitate CAR-T reimbursement, while discussing BMS’s recently launched marketing campaign.

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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 the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional CAR-Ts.

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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 Files an sBLA for Yescarta in 2L R/R DLBCL

On Thursday, September 30, Gilead (Kite) announced (press release) that they have submitted an sBLA to the FDA for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Of note, Yescarta’s sBLA application is supported by data from the Ph3 ZUMA-7 trial in 2L r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s estimated FDA approval timeline for 2L r/r DLBCL, while discussing how Breyanzi (BMS) and Kymriah (Novartis) compare in the 2L 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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JW Tx’s Relma-cel (JWCAR029; CD19 CAR-T) Approved in China as Benoda for ≥3L R/R LBCL

On Friday, September 3, the Chinese NMPA announced (press release) the approval of JW Therapeutic’s relma-cel (relmacabtagene autoleucel / JWCAR029; CD19 CAR-T) in ≥3L r/r LBCL. Of note, relma-cel will be commercialized under the brand name Benoda. Below, Celltelligence provides insights on potential reimbursement hurdles JW Tx may face in China, while discussing Kymriah’s (Novartis’s CD19 CAR-T) delayed Chinese 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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The EC Grants Abecma (BCMA CAR-T) Conditional Marketing Authorization for ≥4L R/R MM

On Thursday, August 19, BMS announced (press release) that the European Commission (EC) granted Conditional Marketing Authorization for Abecma (BCMA CAR-T) in ≥4L r/r MM. Below, Celltelligence provides insights on Abecma’s conditional approval in the EU while discussing how BMS’s manufacturing strategy could impact Abecma’s TATs in Europe.

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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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Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and cilta-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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