JPM 2024 Analysis Day 3: Allogene
On the third day of JPM 2024, Celltelligence covered Allogene’s event (presentation / webcast). Below, Celltelligence provides insights and context to the presentation covering the following topics:
On the third day of JPM 2024, Celltelligence covered Allogene’s event (presentation / webcast). Below, Celltelligence provides insights and context to the presentation covering the following topics:
On Wednesday, August 2, Allogene held its Q2 2023 earnings call (press release) highlighting the progress of ALLO-501A’s (allogeneic CD19 CAR-T) Ph1/2 ALPHA2 trial in ≥3L LBCL and the EMA Clinical Trial Application approval to expand the study to Europe. Below, Celltelligence provides insights on ALPHA2 and Ph2 EXPAND trial timelines, while discussing the company’s potential strategy for the Ph3 ALPHA3 trial in LBCL.
On Wednesday, May 3, Allogene held its Q1 2023 earnings call (press release / presentation) highlighting the progress made in ALLO-501A’s (allogeneic CD19 CAR-T) ALPHA2 trial while admitting that some clinical trial sites have declined to participate in the EXPAND trial due to its randomized design. Below, Celltelligence provides insights on the consequences of Allogene’s decision to include ALLO-647 (anti-CD52 mAb) in its lymphodepletion regimen for the administration of ALLO-501A and its other cell therapies while discussing potential plans to partner for the development of any of its cell therapy programs.
On Tuesday, February 28, Allogene held its Q4 and FY 2022 (press release) highlighting that their top priority for 2023 is ALLO-501A’s (allogeneic CD19 CAR-T) Ph2 ALPHA2 trial in ≥3L DLBCL, while the clinical development for ALLO-715 (allogeneic BCMA CAR-T) and ALLO-605 (allogeneic BCMA TurboCAR-T) is paused until 2024. Additionally, the company will focus on ALLO-316’s (allogeneic CD70 CAR-T) development in solid tumors with the possibility to expand into liquid tumors. Below, Celltelligence provides insights on Allogene’s decision to focus on ALLO-501A, while discussing ALLO-316’s combination with checkpoint inhibitors in solid tumors and its expansion in hematological tumors.
A series of cell therapy-related news items have been observed:
On Tuesday, November 29, Allogene held an R&D showcase (press release / presentation) providing updated clinical milestones and results from ALLO-501A (allogeneic CD19 CAR-T) and ALLO-715 (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on the new data presented by Allogene from its hematology franchise, while discussing potential regulatory timelines for ALLO-501A and how it could compete with approved autologous CAR-Ts.
On Wednesday, November 2, Allogene held its Q3 2022 earnings call (press release) highlighting the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) Ph2 ALPHA2 trial in r/r LBCL and its potential expansion into the EU. Furthermore, management announced an R&D showcase on November 29, 2022, to provide updates on the ALLO-501A and ALLO-715 (allogeneic BCMA CAR-T) programs, while results from ALLO-715’s Ph1 UNIVERSAL study will also be presented at ASH 2022. Below, Celltelligence provides insights on Allogene’s potential involvement in ALLO-501A’s ex-US development, while discussing its allogeneic BCMA CAR-T strategy.
On Thursday, October 6, Allogene announced (press release) the initiation of ALLO-501A’s (allogeneic CD19 CAR-T) potentially pivotal Ph2 ALPHA2 trial in patients with r/r LBCL. Additionally, management confirmed that they are in the process of initiating ALLO-647’s (anti-CD52 monoclonal antibody) EXPAND study. Below, Celltelligence provides insights on both trials, while discussing potential approval timelines for ALLO-501A.
On Wednesday, September 21, Allogene reported (SEC Filing) that Servier has discontinued its involvement in the development of allogeneic CD19-directed assets, including Allogene’s most advanced candidates such as ALLO-501, ALLO-501A, and UCART19. Below, Celltelligence provides insights on how the lack of an ex-US licensing partner could affect Allogene’s pipeline development.
On Tuesday, August 9, Allogene held their Q2 2022 earnings call (press release) highlighting an anticipated FDA clearance of ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial in ≥3L DLBCL, while announcing the deprioritization of ALLO-715’s (allogeneic BCMA CAR-T) combination with nirogacestat. Of note, no major updates were presented from ALLO-316’s (allogeneic CD70 CAR-T) clinical development. Below, Celltelligence provides insights on how Allogene could accelerate ALLO-501A’s regulatory pathway, while discussing Allogene’s upcoming clinical updates.