Tag Archives: ALLO-605

ALLO-501A’s ALPHA2 Trial to Start Enrollment Ex-US; EXPAND Continues Recruiting Slowly; ALPHA3 Trial Redefined; Allogene’s Q2 2023 Earnings Call Summary

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.

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.

ALLO-501’s ALPHA2 Trial Progresses but EXPAND Study Might Experience Difficulties to Enroll; ALLO-316’s AACR Results Highlighted; Allogene Ready for Partnerships to Advance its Programs; Allogene’s Q1 2023 Earnings Call Summary

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.

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.

ALLO-501A’s Pivotal Trial in ≥3L DLBCL Top Priority for 2023; Clinical Development of BCMA CAR-Ts Postponed Until 2024; Allogene’s Q4 2022 Earnings Call Summary

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.

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’s R&D Showcase 2022: Celltelligence Analysis – Part 1

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.

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 Expand ALLO-501A’s Pivotal Trial to Europe; Clinical Updates Ahead of ASH 2022; New Manufacturing Facility in China; Allogene’s Q3 2022 Earnings Call Summary

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.

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 to Potentially Clear ALLO-501A’s Pivotal Study in Q3 2022; Nirogacestat Combo Deprioritized; Data from ALLO-316 Delayed to 2023; Allogene Q2 2022 Earnings Call Summary

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.

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.

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.

Gracell to Open an R&D Facility in the US; JPM 2022 Days 2 & 3: Legend, Allogene, and Autolus

A series of cell therapy-related news items have been 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.

When Will the FDA Lift Allogene’s Clinical Hold on AlloCAR-T Programs? Allogene to Present Major Clinical Updates at ASH 2021; Could ALLO-501A’s Pivotal Trial Include Consolidation Dosing? Allogene Q3 2021 Earnings Call Summary

On Thursday, November 4, Allogene held their Q3 2021 earnings call (press release) highlighting their interactions with the FDA to resolve the clinical hold on their AlloCAR-T clinical programs and preparation for ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial. Moreover, management outlined the clinical data expected from their CD19 and BCMA CAR-T programs at ASH 2021. Below, Celltelligence will discuss Allogene’s clinical hold and the potential impact to their joint venture with Overland Pharma, while providing insights on the likelihood of ALLO-501A’s pivotal trial, including consolidation dosing.

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.