Tag Archives: BMS

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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Thoughts on Abecma’s Positive CHMP Opinion for a Conditional Approval in ≥4L R/R MM

On Friday, June 25, BMS announced (press release) that the CHMP adopted a positive opinion for Abecma’s (idecabtagene vicleucel; BCMA CAR-T) conditional marketing authorization in ≥4L r/r multiple myeloma (MM). If approved by the EC, Abecma would become the first CAR-T treatment approved for r/r MM in Europe. Below, Celltelligence provides thoughts on Abecma’s positive CHMP opinion and its potential launch strategy within Europe, while comparing Abecma’s regulatory status between the EU and the UK.

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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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Will Abecma Receive a Positive CHMP Opinion by June 24? Breyanzi’s EU Regulatory Delay Continues; CAT Agenda June 2021

On Wednesday, June 16, the Committee for Advanced Therapies’s (CAT) agenda (June 16 – 18) was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed as ‘for opinion’ in June’s CAT agenda, while BMS has requested a clock-stop extension for Breyanzi (BMS; CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

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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 Reports Positive Topline Results From Breyanzi’s Ph3 TRANSFORM Trial in 2L DLBCL vs SoC: Will Breyanzi be the First Approved CAR-T in 2L DLBCL?

On Thursday, June 10, BMS reported positive topline results from Breyanzi’s (CD19 CAR-T) Ph3 TRANSFORM trial in 2L DLBCL (press release). Below, Celltelligence provides insights on how Breyanzi’s potential approval timeline in 2L DLBCL compares with key competitors Kymriah (Novartis) and Yescarta (Gilead / Kite).

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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 Continues to Demonstrate Best-in-Class Efficacy With an Improved Safety Profile; Abecma’s Efficacy in Hard-to-Treat Subgroups; Could Gracell’s FasTCAR GC012F (BCMA x CD19) Further Decrease TATs? Thoughts on Arcellx’s Initial Results From CART-ddBCMA; ASCO 2021 Day 4

On the final day of ASCO 2021, eight key clinical updates were presented from JNJ / Legend, BMS, Gracell, and Arcellx. Below, Celltelligence provides insights and context for each presentation.

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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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Taking BMS to Court: Will Ex-Celgene’s Shareholders Recover Anything From the Failed CVR?

On Thursday, June 3, Ex-Celgene shareholders filed a case against BMS for missing Breyanzi’s approval deadline and intentionally sinking a multi-billion dollar CVR deal (press release, FiercePharma, Jun 2021). Below, Celltelligence provides insights on potential arguments that ex-Celgene shareholders and BMS could put forward while discussing possible outcome scenarios.

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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 Reimbursement in Japan Matched to Kymriah’s and Yescarta’s

On Wednesday, May 19, Japan’s Ministry of Health, Labor, and Welfare (MHLW) listed Breyanzi (BMS) in the NHI’s reimbursement price list (publication, Nichiyaku, May 2021). Below, Celltelligence provides thoughts on Breyanzi’s lower price in Japan while discussing the potential impact on pricing for upcoming cell therapies.

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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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No Mention of Abecma, Breyanzi, or Cilta-cel in May’s CHMP Agenda

On Monday, May 17, the CHMP agenda for May was released. Of note, no major updates were observed for Abecma (BMS), Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides an update on likely EU approval timelines for Abecma, Breyanzi, and cilta-cel.

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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 BMS’s New Abecma Ph1/2 KarMMa-7 Basket Combination Trial

On Thursday, April 22, a new Abecma (BCMA CAR-T) Ph1/2 combinational trial (KarMMa-7) for the treatment of r/r MM was observed on CT.gov. Below, Celltelligence provides insights on how BMS could strategically leverage the Ph1/2 KarMMa-7 trial to improve Abecma’s efficacy while investigating several fully owned compounds to disrupt the current SOC regimens for r/r MM.

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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 Announces New EU Manufacturing Site in the Netherlands; AUTO4 (TRBC1 CAR-T) Receives Innovation Passport and ILAP Designation; Allogene’s ALLO-715 Receives RMAT Designation by the FDA; No Major Updates in April’s CHMP Agenda

On Thursday, April 22, BMS announced (press release) that they plan to build a new cell therapy manufacturing site in Europe. Furthermore, Autolus confirmed (press release) that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted AUTO4 an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) evaluating the TRBC1-targeting CAR-T in a Ph1/2 trial for peripheral T cell lymphoma (PTCL). Allogene announced (press release) that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 (BCMA CAR-T) for the Ph1 UNIVERSAL trial in r/r MM. Finally, no major regulatory updates were observed for Abecma, Breyanzi, or cilta-cel from this week’s April CHMP Agenda (publication). Below, Celltelligence provides insights into BMS’s potential manufacturing strategy in Europe. Moreover, Celltelligence will provide thoughts on AUTO4’s ILAP designation and how this may accelerate approvals compared to the EMA’s PRIME designation, while discussing ALLO-715’s RMAT designation.

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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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