Category Archives: CAR-T

BMS and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.

This content is for Read Less members only.
Register
Already a member? Log in here

JNJ BCMA CAR-T, JNJ-4528, US filing on track for YE 2020, but EU delayed to H1 2021; JNJ Q2 2020 earnings call

Thursday, 16 July, JNJ held their Q2 2020 earnings call (press release / slides). The company confirmed that filing of their BCMA CAR-T for multiple myeloma, JNJ-4528 (cilta-cel), remains on track for YE 2020 in the US. However, EU filing has been pushed back slightly to early 2021 (from YE 2020). Meanwhile, despite the impact of COVID-19, JNJ reported double-digit QoQ growth of its multiple myeloma blockbuster, Darzalex (US +33%; WW +16%). Below, Celltelligence provides further context on JNJ-4528 and how Darzalex’s sales resilience could help support continued CAR-T development and future commercialization.

This content is for Read Less members only.
Register
Already a member? Log in here

Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

This content is for Read Less members only.
Register
Already a member? Log in here

Two New Gracell Early Ph1 Trials in MM and NHL Posted

Two new early Ph1 trials from Gracell have been observed on CT.gov: a BCMA/CD19 dual CAR-T in ≥4L R/R MM and another trial evaluating GC022F, a CD22 CAR-T rapidly manufactured <24 hours in ≥2L R/R NHL. Interestingly, both trials are being conducted at the same hospital. Below, FENIX provides insights on these new trials, particularly around how a BCMA/CD19 dual CAR-T could differentiate Gracell within the crowded BCMA MM space.

This content is for Read Less members only.
Register
Already a member? Log in here

Autolus Ph1/2 ALLCAR19 Results and EHA 2020 Investor Call Summary

On Friday, June 12, Autolus held an investor call (press release/ presentation), highlighting updated clinical data from the AUTO1 (CD19 CAR-T) Ph1/2 ALLCAR19 study in ≥2L adult ALL. The data was also presented at EHA (Claire Roddie et al, June 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and Cellectis (UCART19).

This content is for Read Less members only.
Register
Already a member? Log in here

Ziopharm Appoints Carl June as Chairman of Scientific Advisory Board

On Monday, June 15, Ziopharm announced (press release) the appointment of Carl June as chairman to the company’s newly formed scientific advisory board (SAB). Below, FENIX provides thoughts on this appointment, particularly around June’s experience pioneering the initial CAR-T studies leading to the commercialization of Kymriah.

This content is for Read Less members only.
Register
Already a member? Log in here

Thoughts on Ziopharm’s CAR-T And TCR-T Program Updates, Including Their Rapid Personalized Manufacturing Technology; Q1 2020 Call

On May 7, 2020, Ziopharm held their Q1 2020 earnings call (press release/slides), highlighting their clinical and regulatory milestones for both TCR-T and CAR-T programs. Below, FENIX provides thoughts on Ziopharm’s CD19 CAR-T and TCR-T pipeline, particularly within the context of COVID-19.

This content is for Read Less members only.
Register
Already a member? Log in here

Novartis Discusses Their Activated Rapid Manufacturing Program and Kymriah in the Community Setting

On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).

This content is for Read Less members only.
Register
Already a member? Log in here