Category Archives: Topics

New JNJ KLK2 CAR-T (JNJ-75229414) Ph1 Trial in mCRPC Posted; Priti Hegde Joins TCR2 Tx’s Board of Directors

On Thursday, August 26, a new Janssen-sponsored Ph1 trial evaluating JNJ-75229414 (KLK2 CAR-T) in metastatic castration-resistant prostate cancer (mCRPC) was observed on CT.gov. On the same day, TCR2 Tx announced (press release) the appointment of Priti Hegde to its Board of Directors. Below, Celltelligence provides further details on JNJ-75229414’s clinical trial, the potential challenges JNJ (Janssen) may encounter targeting a solid tumor indication, how a CAR-T product could fit into JNJ’s prostate portfolio, and how Priti Hegde’s appointment could accelerate TCR2 Tx’s development of TRuC-T cells.

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.

UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated US approvals and submissions following key Q2 2021 earnings presentations and recent press releases (see below for download).

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.

Novartis’s Ph3 BELINDA Trial Fails in 2L NHL; All Eyes on 2L Positive Data for Yescarta and Breyanzi

On Tuesday, August 24, Novartis announced (press release) an update on Kymriah’s (CD19 CAR-T) Ph3 BELINDA trial in 2L NHL. Of note, the BELINDA study did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis could use this opportunity to accelerate Kymriah’s indication in r/r FL, while prioritizing their more novel next-generation CAR-T programs.

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.

Cilta-cel’s Review Progresses in the US and EU; Legend Continues Expanding their CARTITUDE Program; Legend Q2 2021 Earnings Call Summary

On Monday, August 23, Legend released their Q2 2021 results (press release) highlighting the initiation of cilta-cel’s (BCMA CAR-T) review processes for r/r MM in the US and Europe. Furthermore, management noted the expansion of the CARTITUDE program with the initiation of a Ph3 CARTITUDE-5 trial for newly diagnosed MM (NNMM) patients. Below, Celltelligence provides insights on likely US and EU approvals for cilta-cel, while commenting on Legend’s aggressive strategy to move cilta-cel into earlier lines of therapy.

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 Accepts Gilead’s KITE-363 (CD19 x CD20 CAR-T) IND in LBCL

On Thursday, August 19, Gilead (Kite) announced (press release) that the FDA has accepted the IND for KITE-363 (CD19 x CD20 CAR-T) in LBCL. Below, Celltelligence provides details on KITE-363’s IND application while discussing potential competition KITE-363 may face upon approval.

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.

Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, 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.

Precision BioSciences Provides No Major Clinical Updates; Precision Q2 2021 Earnings Call Summary

On Thursday, August 12, Precision BioSciences reported their Q2 2021 results (press release) highlighting data presented at ASCO 2021 from PBCAR0191’s Ph1/2a trial in r/r NHL and ALL. Furthermore, management confirmed the dosing of the first patient in both PBCAR19B (stealth CD19 CAR-T) and PBCAR269A (BCMA CAR-T) programs. Below, Celltelligence provides details on Precision’s upcoming milestones.

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.

Ziopharm’s RPM CD19 CAR-T Ph1 Trial in Taiwan Paused; Clinical Programs Continue to Face Delays; Ziopharm Q2 2021 Earnings Call Summary

On Monday, August 9, Ziopharm held their Q2 2021 earnings call (press release / presentation) highlighting that their TCR-T Library program is anticipated to dose the first patient in Q4 2021. Furthermore, management disclosed that their RPM CD19 CAR-T Ph1 trial for lymphoid malignancies in Taiwan will be paused until the manufacturing process is optimized. Below, Celltelligence provides insights on how Ziopharm’s manufacturing strategy may strengthen their TCR-T Library program while discussing the significance of their RPM CD19 CAR-T program delay.

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.