ALLO-501 / Allogene Therap, Cellectis, MaxCyte - LARVOL DELTA

Allogeneic CAR T Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase 1 Experience From the ALPHA2/ALPHA Clinical Studies. (PubMed, J Clin Oncol) - "Allogeneic CD19 CAR T cells demonstrated promising overall and durable complete response rates with a manageable safety profile in CD19 CAR T-naive patients with R/R LBCL, supporting additional evaluation of cema-cel in patients with LBCL."

Journal • P1 data • B Cell Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Announces Publication of Durable Response Data from Phase 1 ALPHA/ALPHA2 Trials of the Allogeneic CAR T Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma in the Journal of Clinical Oncology (GlobeNewswire) - P1 | N=74 | ALPHA | P1/2 | N=160 | ALPHA2 (NCT04416984) | Sponsor Allogene Therapeutics | "As of the data cutoff date (September 26, 2024), 87 heavily pretreated patients with R/R non-Hodgkin lymphoma (NHL) were treated in the ALPHA/ALPHA2 studies....Patients who achieved a CR had excellent outcomes with a median DOR, PFS (progression free survival) and OS of 23.1 months, 24 months, and not reached, respectively. For patients receiving the selected Phase 2 regimen, median DOR was 23.1 months and median OS was not reached.....ORR and CR rates in the ALPHA/ALPHA2 trials were consistent with those observed with approved autologous CD19 CAR T cell products for patients with R/R LBCL after two or more lines of systemic therapy. All treatment regimens studied demonstrated clinical benefit."

P1 data • Large B Cell Lymphoma

ALLO-647 for Lymphodepletion in the Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and Follicular Lymphomas (ASH 2023) - P1, P1/2 | "Updated phase 1 data for ALLO-501 (ALPHA; NCT03939026) and ALLO-501A (ALPHA2; NCT04416984) showed that administration of anti-CD19 allogeneic CAR T product following use of lymphodepletion that includes ALLO-647 plus fludarabine and cyclophosphamide provided durable responses and an acceptable safety profile in CAR T-cell–naive pts with r/r large B-cell lymphoma (LBCL; Locke FL, et al. These data suggest allogeneic CAR T-cell products administered following lymphodepletion consisting of FC and ALLO-647 can provide a safe and tolerable alternative to autologous CAR T-cell therapy."

Clinical • Anemia • CNS Disorders • Cytomegalovirus Infection • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Rare Diseases • Respiratory Diseases • Thrombocytopenia

DURABLES RESPONSES ACHIEVED WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF AUTOLOGOUS CAR T-NAÏVE PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL) (EHA 2023) - P1, P1/2 | "Conditioning with a regimen of fludarabine (F)/cyclophosphamide (C)/ALLO-647 (A, a humanized anti-CD52 monoclonal IgG1) targets host CD52+ immune cells for elimination while allowing subsequently infused CD52-knock-out ALLO-501/501A cells to persist. A single dose of AlloCAR T therapy following FCA90 conditioning provided durable responses with a manageablesafety profile in autologous CAR T-naïve pts with r/r LBCL. Among 8 pts who received FCA90 and ALLO-501/501A and had the opportunity to be evaluated for 6 months, 50% maintained that response for at least 6 months, with a median DOR of 23.1 months. These findings support broader evaluation of ALLO-501A/ALLO-647 in the ongoing, first potentially pivotal phase 2 trial (ALPHA2) of AlloCAR T therapy."

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase 1 results with anti-CD19 allogeneic CAR T ALLO-501/501A in relapsed/refractory large B-cell lymphoma (r/r LBCL). (ASCO 2023) - P1, P1/2 | " In these two multicenter, single-arm, open-label, phase 1 trials, a cohort of autologous CAR T-naïve pts with r/r LBCL underwent 3-day lymphodepletion (LD) with FCA90, fludarabine (F, 30 mg/m2/day), cyclophosphamide (C, 300 mg/m2/day), and ALLO-647 (A [anti-CD 52 mAb] 30 mg/day; total dose: 90 mg) followed by a single dose of ALLO-501 or ALLO-501A produced by the Alloy manufacturing process. A one-time dose of allogeneic CAR T therapy following LD with FCA90 provided durable responses with a manageable safety profile in patients with r/r/ LBCL comparable to those treated with autologous CAR T cells. This treatment enables rapid access to off-the-shelf treatment with a median time from trial enrollment to treatment of 3 days. These findings support broader evaluation of ALLO-501A in the ongoing, first potentially pivotal phase 2 trial (ALPHA2) of off-the-shelf allogeneic CAR T cells."

P1 data • Diffuse Large B Cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Announces Poster Presentations at the 65th Annual Meeting of the American Society of Hematology (GlobeNewswire) - "The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion....The second poster showcases translational results from ALPHA2 generated through a collaboration with researchers from The University of Texas MD Anderson Cancer Center."

P1 data • Review • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Provides Additional ALLO-501/501A Phase 1 Data in an Oral Presentation at the International Conference on Malignant Lymphoma (ICML) Lugano (GlobeNewswire) - P1/2 | N=160 | ALPHA2 (NCT04416984) | P1 | N=74 | ALPHA (NCT03939026) | Sponsor: Allogene Therapeutics | "Allogene Therapeutics...at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland presented updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in 33 CAR T naïve patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL)....The updated analysis (data cutoff April 20, 2023) of ALPHA/ALPHA2 examined data from all 33 CAR T-naïve patients with r/r LBCL....Seven of 12 (58%) patients receiving the Phase 2 regimen achieved a CR and five (42%) maintained a CR through Month 6. Of the five patients who were in CR at 6 months, four (80%) remained in CR. The fifth patient had disease progression at 24 months. The median duration of response was 23.1 months with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

DURABLES RESPONSES WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL) (ICML 2023) - P1, P1/2 | "New data document the durability of responses achieved with ALLO-501/501A following conditioning with fludarabine (F), cyclophosphamide (C), and ALLO-647 (A). ALLO-501/501A following FCA conditioning provided durable responses with a manageable safety profile in autologous CAR T-naïve pts with r/r LBCL. Durable complete remissions continue in 9 pts with the longest ongoing response at 29.6 months. These findings support broader evaluation of ALLO-501A/ALLO-647 in the ongoing, first, potentially pivotal phase 2 trial (ALPHA2) of allogeneic CAR T therapy."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-501/501A in Large B Cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) Lugano (GlobeNewswire) - "Allogene Therapeutics...announced it will present data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) in an oral presentation at the International Conference on Malignant Lymphoma (ICML) on June 13-17, 2023....Long-term follow up data from phase 1 ALPHA/ALPHA2 trials demonstrates potential of allogeneic CD19 CAR T to generate durable complete responses similar to approved autologous therapies. Presentation recaps 12 patients treated with phase 2 dose regimen and includes additional data on all 33 CAR T naïve patients treated with the Alloy™ manufacturing process. Potentially pivotal phase 2 ALPHA2 Trials ongoing in the US; Sites in Europe, Canada and Australia expected to enroll during 2023."

P1 data • Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Presents Updated ALLO-501/501A Phase 1 Data in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1/2 | N=160 | ALPHA2 (NCT04416984) | P1 | N=74 | ALPHA (NCT03939026) | Sponsor: Allogene Therapeutics | "Allogene Therapeutics, Inc...presented long-term follow up data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois....As of the data cutoff, 7 of 12 (58%) patients achieved a CR and five (42%) maintained a CR through Month 6. Of the five patients who were in CR at 6 months, four (80%) remained in CR. The fifth patient had disease progression at 24 months. The median duration of response was 23.1 months with three patients remaining in remission for over 24 months and the longest remaining in remission for over 31 months....Allogene is currently enrolling the potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in LBCL and expects to complete enrollment in 1H2024."

Enrollment status • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Announces Encore Presentation of Phase 1 Data from the ALLO-501/501A Trials in Large B Cell Lymphoma at the European Hematology Association (EHA) Hybrid Congress (GlobeNewswire) - "Allogene Therapeutics, Inc...today announced an encore presentation of data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the European Hematology Association (EHA) Hybrid Congress on June 8–11, 2023 in Frankfurt, Germany....Allogene is conducting ALPHA2 and EXPAND, two potentially pivotal Phase 2 trials of ALLO-501A in large B cell lymphoma (LBCL) in sites across the U.S. and is expected to extend its clinical research footprint to Europe, Canada and Australia in 2023."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Announces Presentation of Phase 1 Data from the ALLO-501/501A Trials in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Allogene Therapeutics, Inc...today announced it will present updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the American Society of Clinical Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois."

P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

"Bullish for lifileucel and ALLO-501!!" (@retailbiotech)

Allogene Therapeutics R&D Showcase Features Hematologic and Solid Tumor Advances Across its AlloCAR T Platform (GlobeNewswire) - P1 | N=74 | ALPHA (NCT03939026) | P1/2 | N=60 | ALPHA2 (NCT04416984) | Sponsor: Allogene Therapeutics | "Data from the Phase 1 trials of ALLO-501 and ALLO-501A support the ability of a single administration of CAR T cells to generate deep and durable responses similar to approved autologous CAR T therapies. As of the October 25, 2022 data cutoff, 33 autologous CAR T naïve patients with relapsed/refractory (r/r) LBCL were treated with Alloy process material....Responses in the ALPHA trials were overall durable. Of the nine patients treated with Alloy process material who achieved a complete response (CR) at six months, eight remain in remission with the longest complete response ongoing at 26+ months. Among 12 patients treated with the Single Dose FCA90 regimen, the overall response rate (ORR) was 67% and 58% achieved CRs."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ALPHA Study: ALLO-501 Produced Deep and Durable Responses in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma Comparable to Autologous CAR T (ASH 2021) - P1 | "Pts with donor specific antibodies and baseline rituximab >15 ng/mL were excluded. Following LD with ALLO-647 (39, 60, or 90 mg), fludarabine 30 mg/m 2 /d x 3d (F), and cyclophosphamide 300 or 500 mg/m 2 /d x 3d (C), escalating doses of ALLO-501 (40, 120, or 360 x 10 6 viable CAR T cells [DL1, DL2 and DL3]) were given...NEJM 2019;380:45-56). Consolidation dosing demonstrated similar safety and improved efficacy vs single dosing with ORR of 100% and CR of 75% in pts who had tumor evaluation after consolidation."

Clinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases

Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates (FierceBiotech) - "CAR-T therapies targeting CD19 might be considered a hot ticket in biotech, but that hasn’t stopped French pharmaceutical research company Servier from scrapping its collaboration with Allogene Therapeutics. Servier notified the South San Francisco-based company Sept. 15 that it is pulling out of developing the CD19 CAR-Ts the two companies were working on. Of these drugs, UCART19 is in a phase 2 trial for hematological malignancies, while two other candidates-ALLO-501 and ALLO501A-reached phase 1 trials for relapsed/refractory large B-cell lymphoma....With Servier out of the picture, Allogene said in its Securities and Exchange Commission (SEC) filing that it will now pursue licensing these therapies outside the U.S., with potentially an additional 46 million euros ($54.4 million) to come in milestone payments for ALLO-501A."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ALPHA: Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma (clinicaltrials.gov) - P1 | N=74 | Active, not recruiting | Sponsor: Allogene Therapeutics | Trial completion date: Sep 2024 ➔ Aug 2026 | Trial primary completion date: Jan 2022 ➔ Dec 2022

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cellectis Provides Business Update and Reports 4th Quarter and Full Year 2021 Financial Results (GlobeNewswire) - "Enrollment in the Phase 1 ALLO-501 ALPHA trial in r/r NHL has completed accrual. Allogene disclosed that its focus remains on preparing for the pivotal Phase 2 ALPHA2 trial of ALLO-501A in R/R Large B Cell Lymphoma (LBCL), which Allogene reports to be on track to begin mid-year 2022 subject to ongoing discussions with the FDA....Allogene intends to launch a separate registrational trial for ALLO-647, Allogene’s anti-CD52 monoclonal antibody, at the time of the ALLO-501A pivotal Phase 2 trial. This trial is intended to demonstrate the safety of ALLO-647 along with its contribution to the overall benefit of the lymphodepletion regimen."

Enrollment closed • New P2 trial • New trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Reports Positive Phase 1 Data from the ALPHA Trials in Non-Hodgkin’s Lymphoma at the 63rd Annual Meeting of the American Society of Hematology (GlobeNewswire) - P1, N=74; ALPHA (NCT03939026); Sponsor: Allogene Therapeutics; “'Results from the ALPHA study presented at the 2021 ASH Annual Meeting confirm that ALLO-501 can be safely, effectively and conveniently delivered to LBCL and FL patients, with durable responses observed in both lymphoma subtypes. These data are on par with autologous CAR T therapy and suggest that an off-the-shelf product could be a promising option for patients with relapsed/refractory NHL,'....”

P1 data • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics to Showcase Clinical Data from the ALPHA, ALPHA2 and UNIVERSAL AlloCAR T Trials at the 63rd Annual Meeting of the American Society of Hematology (GlobeNewswire) - P1, N=74; ALPHA (NCT03939026); Sponsor: Allogene Therapeutics; "As of the July 9, 2021 ASH abstract data cutoff, five additional patients were treated relative to the data previously reported at the 2021 ASCO Annual Meeting. ORR and CR rates remain at 75% and 50%, respectively. In patients with LBCL (n=13), the ORR was 62% and the CR rate was 46%. In patients with FL (n=23), the ORR was 83% and the CR rate was 52%. Four of the seven patients (all FL) enrolled in the consolidation cohort were evaluable for assessment after consolidation dosing at the time of the data cutoff with an ORR and CR rate of 100% and 75%, respectively."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

ALPHA: Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma (clinicaltrials.gov) - P1; N=74; Active, not recruiting; Sponsor: Allogene Therapeutics; Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Clinical • Enrollment closed • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Safety and PK/PD of ALLO-647, an anti-CD52 antibody, with fludarabine (Flu)/cyclophosphamide (Cy) for lymphodepletion in the setting of allogeneic CAR-T cell therapy. (ASCO 2021) - P1 | "ALLO-501 (anti-CD19; uses Cellectis technologies) and ALLO-715 (anti-BCMA) are allogeneic CAR T cell products whose a) disrupted TCRα constant gene may reduce GvHD risk, and b) edited CD52 gene may permit use of ALLO-647 (a humanized anti-CD52 mAb) to selectively deplete host T cells . ALLO-647/Flu +/- Cy had a tolerable safety profile and produced a deep and durable window of lymphocyte depletion . ALLO-647 exhibited target-mediated drug disposition; clearance increased with higher baseline LC . HD was associated with higher IL15 levels and better CAR T expansion, suggesting dose responses ."

CAR T-Cell Therapy • Clinical • PK/PD data • Anemia • Follicular Lymphoma • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • CD52 • IL15

[VIRTUAL] First-in-human data of ALLO-501 and ALLO-647 in relapsed/refractory large cell or follicular lymphoma (R/R LBCL/FL): ALPHA study. (ASCO 2020) - "Embargoed. Will be released on: May 13, 2020"

P1 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

Allogene Therapeutics Reports Second Quarter 2021 Financial Results (GlobeNewswire) - "ALLO-501 and ALLO-501A demonstrated a manageable safety profile with no dose limiting toxicities or graft-vs-host disease, limited immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) observed. Next readout from this program is expected in late 2021....The Company plans to collect additional data from the consolidation arms of the ALPHA and ALPHA2 studies, finalize a dose and schedule of ALLO-501A and lymphodepletion for a pivotal Phase 2 trial, and discuss the Phase 2 trial design with regulatory authorities. Pending regulatory feedback, the Company plans to move to the Phase 2 Pivotal ALPHA2 trial at the end of 2021."

Clinical protocol • P1 data • P1/2 data • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Moffitt Cancer Center experts to present new clinical research data (Eurekalert) - "Moffitt Cancer Center...is presenting new data from dozens of clinical research studies at this year's American Society of Clinical Oncology (ASCO) Annual Meeting, the world's largest clinical cancer research meeting. Moffitt investigators will lead 25 abstract presentations, five education sessions, two cancer-based panels and two clinical science symposia. The virtual meeting is June 4-8."

Clinical data • Acute Lymphocytic Leukemia • Breast Cancer • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology