Tag Archives: bluebird bio

Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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Afami-cel’s BLA Filing on Track for 2022; Next-Gen MAGE-A4 SPEAR-T To Treat Ovarian Cancer; 2seventy Successfully Launched; Adaptimmune Q3 2021 Earnings Call Summary

On Thursday, November 4, Adaptimmune held their Q3 2021 earnings call (press release) highlighting that they are preparing the CMC documentation and analytical data for afami-cel’s (MAGE-A4 SPEAR-T; formerly ADP-A2M4) potential BLA filing in 2022. Furthermore, management announced a new ADP-A2M4CD8 (next-gen MAGE-A4 SPEAR-T) Ph2 SURPASS-3 trial in ovarian cancer and discussed the prioritization of ADP-A2M4CD8’s combination with pembrolizumab (PD1 inhibitor) over afami-cel. On the same day, bluebird bio announced (press release) the successful launch of 2Seventy bio.

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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 & 2seventy to Split in October; Marcela Maus Appointed to 2seventy’s Board of Directors; bluebird Receives $75M in Private Equity Financing Before Separation

On Tuesday, September 7, bluebird bio announced (press release) that the separation of their oncology business (2seventy bio) is anticipated to occur in mid-October 2021. Additionally, bluebird appointed Marcela Maus to their Board of Directors. Upon the separation of the two companies, Maus will transition to 2seventy’s Board of Directors. Furthermore, on Wednesday, September 8, bluebird announced (press release) that they have secured an additional $75M in private placement equity financing. Below, Celltelligence provides insights on bluebird’s decision to split into two companies, while discussing how Maus could help 2seventy achieve their clinical development goals.

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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’s Oncology Newco on Track to Launch in Q4 2021; Autolus’s obe-cel Granted PIM Designation by the MHRA; bluebird bio Q2 2021 Earnings Call Summary

On Monday, August 9, bluebird bio held their Q2 2021 earnings call (press release / presentation) highlighting Abecma’s successful US launch and providing updates on bluebird’s upcoming business separation. Additionally, management commented on bluebird’s recent manufacturing alliance with Resilience. On the same day, Autolus announced (press release) that obe-cel (CD19 CAR-T) has received Promising Innovative Medicine (PIM) designation from the MHRA in r/r adult ALL.

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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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Abecma’s Viral Vector Shortage; Could JNJ Take Advantage? BMS Q2 2021 Earnings Call Summary

On Wednesday, July 28, BMS held their Q2 2021 earnings call (press release / presentation), highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) strong demand following their recent US approval, while discussing Abecma’s manufacturing bottleneck due to a shortage of viral vector. On the same day, bluebird bio announced (press release) a strategic alliance with Resilience for the sale of bluebird’s lentiviral manufacturing facility in North Carolina. Below, Celltelligence provides insights on how Abecma’s upcoming approval in the EU could impact BMS’s viral vector shortage and if JNJ could take advantage for cilta-cel’s launch.

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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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First BCMA CAR-T Approved in the US for Multiple Myeloma; Will Abecma’s 33-day TAT and High Price Prevent Wide-Spread Adoption?

On Friday, March 26, BMS and bluebird bio announced (press release) that the FDA approved Abecma (idecabtagene vicleucel) for the treatment of ≥5L r/r MM (i.e. after completing at least 4 lines of prior therapy). Below, Celltelligence provides thoughts on Abecma’s higher list price and longer TAT vs. approved CD19 CAR-Ts, while discussing Abecma’s potential messaging strategy.

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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 New US Cell Therapy Manufacturing Site; bluebird bio Quiet on Earnings; Former Kite Head of Development Joins Daiichi Sankyo

On Tuesday, February 23, BMS announced (press release) the construction of a new cell therapy manufacturing facility in Devens, Massachusetts. On the same day, bluebird bio released their Q4 and FY 2020 results (press release) without an investor call. Finally, Daiichi Sankyo announced (press release) Ken Takeshita, former Kite global head of development, will join the company as global head of R&D. Below, Celltelligence provides insights on BMS’s possible manufacturing footprint strategy, as well as thoughts on how Takeshita’s cell therapy experience could influence Daiichi Sankyo’s R&D strategy.

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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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JPM 2021 Day 1: BMS, bluebird bio, Novartis, and JNJ

On the first day of JPM 2021, Celltelligence covered presentations by BMS, bluebird bio, Novartis, and JNJ. Below, Celltelligence provides a topline summary of key takeaways from each company followed by more in-depth coverage below.

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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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What is Behind Ide-cel’s mPFS and mOS Disparity? Thoughts on Ide-cel’s Launch Messaging and List Price; bb21217’s Manufacturing Updates; bluebird bio ASH Investor Event

On Monday, December 7, bluebird bio held an ASH-related investor event (press release / webcast) discussing recent advances to their BCMA CAR-Ts ide-cel (bb2121) and bb21217 in r/r MM. Below, Celltelligence provides thoughts on the significant differences in ide-cel’s mPFS and mOS data, how the data could influence launch messaging and list price, in addition to summarizing manufacturing updates for bb21217.

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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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ZUMA-12 Reports an 85% ORR in 1L DLBCL; Liso-cel’s Safety Profile vs Kymriah and Yescarta; Comparison of OOS Use of CD19 Commercial CAR-Ts; ASH Day 2

On the second day of ASH 2020, four key clinical updates were presented from Novartis, Gilead, and BMS / bluebird bio. Below, Celltelligence provides insights and context for each presentation.

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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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