Category Archives: Topics

Could Yescarta in 2L LBCL Receive a CHMP Positive Opinion This Week?

On Monday, May 16, the CHMP agenda for May was released. Of note, Yescarta in 2L LBCL has been listed as for adoption under ‘Type II variations – variation of therapeutic indication’.

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.

TCR2 Tx, Poseida, 2seventy bio, and Cellectis Q1 2022 Earnings

A series of cell therapy-related news items were observed:

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.

Afami-cel’s BLA Filing Remains On Track for Q4 2022; ADP-A2M4N7X19’s IND Submission Planned by YE 2022; Precision’s Clinical Updates Expected in June 2022; Adaptimmune and Precision Q1 2022 Earnings Summaries

On Monday, May 9, Adaptimmune held their Q1 2022 earnings call (press release / webcast) highlighting afami-cel’s (autologous MAGE-A4 SPEAR-T; formerly ADP-A2M4) anticipated BLA filing in Q4 2022, while discussing anticipated milestones for their MAGE-A4 franchise. On the same day, Precision BioSciences reported their Q1 2022 financial results (press release) confirming multiple planned clinical updates for June 2022. Below, Celltelligence provides insights on Adaptimmune’s vector supply strategy, while discussing at which conference Precision may present their clinical updates.

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.

Autolus to Evaluate MRD Status in Obe-cel’s FELIX Trial; First Patient Dosed in AUTO8’s MCARTY Study; Autolus Q1 2022 Earnings Call Summary

On Thursday, May 5, Autolus held their Q1 2022 earning call (press release / presentation) highlighting obe-cel’s (CD19 CAR-T; formerly AUTO1) clinical progress, while confirming multiple clinical updates to be presented EHA 2022 (June 9 – 12). Of note, management confirmed the initiation of AUTO8’s (BCMA x CD19 CAR-T) Ph1 MCARTY trial in r/r MM. Below, Celltelligence provides insights on how Autolus may leverage MRD status to improve obe-cel’s efficacy and safety profile in r/r adult ALL, while discussing AUTO8’s trial initiation.

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.

Allogene Plans to Evaluate ALLO-501A in 2L DLBCL; No Updates for Allogene’s BCMA Programs; ALLO-316’s Initial Data Likely Delayed to 2023; CF1 to Produce ~20,000 Doses Annually; Allogene Q1 2022 Earnings Call Summary

On Wednesday, May 4, Allogene held their Q1 2022 earnings call (press release) highlighting their plans to evaluate ALLO-501A (allogeneic CD19 CAR-T) in 2 DLBCL, while noting that ALLO-316’s (allogeneic CD70 CAR-T) initial clinical data may be delayed until 2023. Of note, no major updates were provided for ALLO-501A’s pivotal study or Allogene’s BCMA programs. Below, Celltelligence provides insights on how ALLO-501A could compete with autologous CAR-Ts in the 2L setting, while discussing Allogene’s upcoming clinical updates and manufacturing capabilities.

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.

Breyanzi’s Sales Increase While Abecma’s Remain Flat; BMS Prepares for an Increase in Cell Therapy Demand; No Clinical Milestone Updates for Breyanzi or Abecma; BMS’s Q1 2022 Earnings Call Summary

On Friday, April 29, BMS held their Q1 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) revenue increase and anticipated US approval in 2L LBCL. Of note, no updated clinical milestones for Breyanzi and Abecma (BCMA CAR-T) were observed. Below, Celltelligence provides insights on how Breyanzi’s revenue increase compares with Kymriah (Novartis’s CD19 CAR-T) and Yescarta (Gilead/Kite’s CD19 CAR-T).

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.

Gilead’s Cell Therapy Sales Continue to Grow; Gilead’s New Manufacturing Facility Could Accelerate Yescarta’s Launch in 2L LBCL; Gilead’s Q1 2022 Earnings Call Summary

On Thursday, April 28, Gilead (Kite) held their Q1 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing new clinical developments for Yescarta (CD19 CAR-T). Additionally, management noted the FDA approval of their state-of-the-art manufacturing site in Frederick, MD. Below, Celltelligence provides insights on how Gilead’s new cell therapy facility could assist Yescarta’s expected increase in demand, while discussing Yescarta’s expansion into 2L LBCL.

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.

Gilead’s Oncology Deep Dive 2022: Celltelligence Analysis – Part 2

On Thursday, April 14, Gilead / Kite held their Oncology Deep Dive event (presentation) highlighting a rapid manufacturing process, while discussing strategies to remain innovative in the cell therapy space via robust collaborations and novel technologies. Below, Celltelligence provides a second round of insights on Gilead / Kite’s rapid manufacturing and off-the-shelf cell therapy candidates.

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 Updates for GSK’s Cell Therapy Assets; New GSK Expected to Launch in July 2022; GSK’s Q1 2022 Earnings Call Summary

On Wednesday, April 27, GSK held their Q1 2022 earnings call (press release / presentation) highlighting that their business separation is anticipated to occur in July 2022. Of note, GSK did not provide any updates on their cell therapy assets. Below, Celltelligence provides insights on how lete-cel’s (NY-ESO-1 TCR-T) potential approval timeline compares with Adaptimmune’s afami-cel (MAGE-A4 SPEAR-T), while discussing GSK’s business separation.

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.

Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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.