Tag Archives: Abecma

JNJ / Legend Files Carvykti in Japan for R/R MM

On Monday, December 6, Legend announced (press release) that they have submitted Carvykti’s NDA (cilta-cel; BCMA CAR-T) to Japan’s Ministry of Health Labour and Welfare (MHLW) for the treatment of r/r MM. Below, Celltelligence provides insights on a likely approval timeline for Carvkyti in Japan.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Will 2seventy’s Novel Pipeline Assets be Innovative Enough? 2seventy’s Research Deep Dive Investor Event Summary

On September 21 – 22, 2seventy bio (bluebird bio’s oncology business) held two Research Deep Dive sessions (Day 1 presentation / Day 2 presentation) detailing their novel pipeline assets across liquid and solid tumors. Below, Celltelligence provides insights on how 2seventy’s novel assets compare with key competitors, while discussing innovative manufacturing options for 2seventy.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

No Mention of Breyanzi or Cilta-cel in July’s CHMP Agenda; Will Abecma be Approved Before September?

On Monday, July 19, the CHMP agenda for July was released. Of note, no major updates were observed for Breyanzi (BMS), or cilta-cel (JNJ / Legend). Below, Celltelligence provides likely EU approval timelines for Abecma, Breyanzi, and cilta-cel.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

CHMP Adopts Positive Opinion for BMS’s Abecma in ≥4L r/r MM

On Friday, June 25, the CHMP adopted (press release) a positive opinion for Abecma (idecabtagene vicleucel; BCMA CAR-T) in ≥4L relapsed/refractory multiple myeloma (MM). The Celltelligence team will provide a detailed analysis in the coming days about Abecma’s positive CHMP opinion and BMS’s potential launch strategy within Europe.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Will Abecma Receive a Positive CHMP Opinion on June 24? BMS Seeks a Clock-Stop Extension for Breyanzi; CHMP Agenda June 2021

On Monday, June 21, the CHMP agenda for June was released. Of note, Abecma (BMS’s BCMA CAR-T) has been listed under the Opinions section, while the CHMP appears to require further information in relation to BMS’s clock-stop extension request for Breyanzi (BMS’s CD19 CAR-T). Below, Celltelligence provides updated likely EU approval timelines for Abecma and Breyanzi.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.