Category Archives: CAR-T

ALLO-501A Pivotal Trial on Track to Initiate in Mid-2022; Which BCMA Program Will Be Prioritized? New Registrational ALLO-647 Trial Anticipated for Mid-2022; Allogene Q4 2021 Earnings Call Summary

On Wednesday, February 23, Allogene held their Q4 2021 earnings call (press release) highlighting that their AlloCAR-T studies have resumed enrollment following the removal of the clinical hold in January 2022. Furthermore, Allogene confirmed that ALLO-501A’s pivotal trial is anticipated to start by mid-2022, and the company is preparing CMC data for the BLA submission. Below, Celltelligence provides insights on Allogene’s upcoming clinical updates while discussing how Allogene’s preparation of CMC data could position the company for a successful regulatory review.

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.

Could Yescarta Receive a CHMP Positive Opinion for ≥4L FL This Week? Yescarta’s Evaluation for 2L DLBCL Listed in February’s CHMP Agenda

On Monday, February 21, the CHMP agenda for February was released. Of note, Yescarta’s (Gilead /Kite’s CD19 CAR-T) Type II Variations in ≥4L FL and 2L DLBCL are listed under ‘Type II Variations – Opinions or Requests for Supplementary Information’. No other cell therapy-related updates were observed. Below, Celltelligence provides insights on the potential EU approval timeline for Yescarta in ≥4L FL.

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 Receives Priority Review for Breyanzi in 2L LBCL; Breyanzi’s PDUFA Date Set for June 24, 2022

On Thursday, February 17, BMS announced (press release) that the FDA has granted a Priority Review for Breyanzi (CD19 CAR-T) in 2L LBCL, with a PDUFA date of June 24, 2022. Below, Celltelligence provides additional thoughts on how Breyanzi’s anticipated US approval in the 2L setting compares with Yescarta (Gilead / Kite; 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.

Legend’s CD4 CAR-T Trial in TCL is Placed on Clinical Hold by the FDA

On Tuesday, February 15, Legend announced (press release) that the FDA has placed a clinical hold on LB1901’s (LCAR-T2C; autologous CD4 CAR-T) Ph1 trial in r/r TCL. Below, Celltelligence provides insights on plausible causes of the clinical hold and how competitors may achieve a better safety profile.

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.

2seventy Appoints Steven Bernstein as Their New CMO; Susan Abu-Absi Appointed as 2seventy’s Chief Technology and Manufacturing Officer

On Monday, February 14, 2seventy bio announced (press release) the appointment of Steven Bernstein as Chief Medical Officer (CMO) and Susan Abu-Absi as Chief Technology and Manufacturing Officer. Below, Celltelligence provides insights on how 2seventy could leverage Bernstein’s translational clinical background to bring novel assets into the clinic, while discussing the company’s decision to create a Chief Technology and Manufacturing Officer position. 

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; How Will BMS Meet CAR-T Manufacturing Demand? Breyanzi On Track for EU Approval in 2L LBCL; BMS’s Q4 2021 Earnings Call Summary

On Friday, February 4, BMS held their Q4 2021 earnings call (press release / presentation) highlighting their manufacturing supply strategy for the anticipated increase in demand of Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T). Below, Celltelligence provides insights on the potential challenges BMS may encounter expanding into earlier lines of therapy and additional geographies.

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 Sales Continue to Decline; Could an Approval in FL Offset Kymriah’s Revenue Loss in DLBCL? Novartis’s Q4 2021 Earnings Call Summary

On Wednesday, February 2, Novartis held their Q4 2021 earnings call (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) quarterly sales decline and regulatory submission in Japan for r/r FL. Below, Celltelligence provides insights on Kymriah’s Q4 2021 revenue, while discussing if Kymriah’s upcoming approvals in r/r FL will be enough to offset declining sales.

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.

Yescarta’s Sales Grow; Gilead Prepares for Increased Manufacturing Demands; Tecartus’s EU Approval in R/R Adult ALL Faces Delays; Gilead’s Q4 2021 Earnings Call Summary

On Tuesday, February 1, Gilead held their Q4 2021 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise and Yescarta’s anticipated approval in 2L r/r LBCL. Furthermore, management highlighted Tecartus’s (CD19 CAR-T) Type II variation in the EU for r/r adult ALL. Below, Celltelligence provides insights on how Gilead’s manufacturing strategy could position the company for success, while discussing likely US and EU approvals for Yescarta in 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.

FDA Approves an Updated Label for Yescarta to Include Prophylactic Corticosteroids Use

On Monday, January 31, Gilead (Kite) announced (press release) that the FDA has approved Yescarta’s (CD19 CAR-T) updated prescribing information to include the use of prophylactic corticosteroids across all approved indications. Of note, the label update is based on results from Cohort 6 of the Ph1/2 ZUMA-1 trial in r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s updated US label, while discussing how it could facilitate Yescarta’s administration in the outpatient setting.

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 Breyanzi in ≥3L R/R DLBCL

On Friday, January 28, the CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, the CHMP adopted (press release) a positive opinion for Breyanzi’s (liso-cel; BMS’s CD19 CAR-T) marketing authorization in ≥3L r/r DLBCL, PMBCL, and FL grade 3B. Below, Celltelligence provides thoughts on Breyanzi’s positive CHMP opinion, while comparing Breyanzi’s regulatory EU timeline with other commercialized CAR-Ts.

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.