ALLO-605 / Cellectis, Allogene Overland Biopharm, Overland Therapeutics - LARVOL DELTA

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Allogene Therapeutics | N=136 ➔ 6 | Trial completion date: Jul 2025 ➔ Oct 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Oct 2023; Terminated (Halted Prematurely)

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=136 | Active, not recruiting | Sponsor: Allogene Therapeutics | Trial completion date: Jan 2027 ➔ Jul 2025 | Trial primary completion date: Jan 2024 ➔ Jul 2025 | Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Universal Updated Phase 1 Data Validates the Feasibility of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma (ASH 2021) - P1 | "Several LD regimens are being evaluated: FCA39; FCA60; FCA90; and CA39; with fludarabine [F] 90 mg/m 2 , cyclophosphamide [C] 900 mg/m 2 , and ALLO-647 [A] 39, 60, or 90 mg divided over 3 days...CRS was treated with tocilizumab (21.3%) and corticosteroids (12.8%)...A study using the next generation anti-BCMA CAR (ALLO-605) which supplies cytokine signaling to the CAR bearing cells is ongoing (IGNITE). The current UNIVERSAL trial continues to enroll, including a cohort with consolidation, and updated data will be presented at the meeting."

P1 data • Anemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hepatology • Immune Modulation • Immunology • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR T Cell Product Candidate, for the Treatment of Multiple Myeloma (GlobeNewswire) - "BCMA Program Clinical Updates are Planned for Late 2022...Allogene Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-605, the Company’s next-generation AlloCAR T product candidate targeting BCMA for the treatment of multiple myeloma."

Clinical • Orphan drug • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=136 | Recruiting | Sponsor: Allogene Therapeutics | Active, not recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2; N=136; Active, not recruiting; Sponsor: Allogene Therapeutics; Recruiting ➔ Active, not recruiting

CAR T-Cell Therapy • Clinical • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2; N=136; Recruiting; Sponsor: Allogene Therapeutics

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR T Cell Therapy, for the Treatment of Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - "Allogene Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALLO-605, the Company’s next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021."

Fast track designation • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Cellectis Provides Business Update and Reports Financial Results for First Quarter 2021 (GlobeNewswire) - "BALLI-01 is currently enrolling patients with the FCA2 lymphodepletion regimen...Subject to study progress and data, Cellectis expects to present data on cohorts of patients treated with FCA lymphodepletion by end of 2021, at an upcoming medical conference....Allogene announced that data from the dose escalation Phase 1 ALPHA study of ALLO-501 in r/r NHL will be jointly presented with initial data from the ALPHA2 study of ALLO-501A at the American Society of Clinical Oncology (ASCO) annual meeting....Allogene plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021....The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021."

New P2 trial • P1 data • P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Allogene Therapeutics Reports First Quarter 2021 Financial Results (GlobeNewswire) - “The FDA cleared the Investigational New Drug (IND) application to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in relapsed/refractory MM...The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.”

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - "Allogene Therapeutics, Inc...announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study ALLO-605 for the treatment of patients with relapsed or refractory multiple myeloma. ALLO-605 is part of the company’s multi-faceted strategy to develop an allogeneic CAR T therapy targeting BCMA for the treatment of multiple myeloma. The Phase I IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021....As part of the Company’s anti-BCMA strategy, Allogene continues to enroll relapsed/refractory multiple myeloma patients in the Phase 1 UNIVERSAL study with the goal of optimizing dosing of ALLO-715 and ALLO-647."

Enrollment status • IND • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Allogene Therapeutics Presents Preclinical Research Highlighting a Novel TurboCAR T Cell Technology Designed to Overcome Immune Suppression in Solid Tumors at the American Association for Cancer Research (AACR) Virtual 2021 Meeting (GlobeNewswire) - “Allogene Therapeutics, Inc…announced preclinical data at the American Association for Cancer Research (AACR) Annual Meeting that expands the utility of its TurboCAR™ technology platform to address specific biology of solid tumor oncology….The data presented at AACR demonstrate the ability to engineer PD1 TurboCARs which confer cytokine signaling that is inducible upon binding to PDL1/2 in the tumor microenvironment or when stimulated with an anti-PD1 antibody. In addition to supplying cytokine signaling, these TurboCARs are designed to overcome the inherent challenges in solid tumors associated with the immuno-suppressive tumor microenvironment (TME) and turn the suppressive signals into positive signals.”

Preclinical • Oncology

Allogene Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Corporate Update (Allogene Therapeutics Press Release) - "Additional data from the Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and initial data from the Phase 1 ALPHA2 study of ALLO-501A are planned for Q2 2021. The Company intends to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021....An IND submission is planned for 1H 2021 for ALLO-605, the first anti-BCMA TurboCAR™ T cell therapy, for use in relapsed/refractory MM."

IND • New P2 trial • P1 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Preclinical Evaluation of ALLO-605, an Allogeneic BCMA Turbocar TTM Cell Therapy for the Treatment of Multiple Myeloma (ASH 2020) - "First, we tested the ability of a CD20-based off-switch incorporated within the CAR to sensitize cells to rituximab and found effective depletion of BCMA TurboCAR T™ cells by complement or effector cells in vitro and in vivo in the presence of the antibody. In addition, we confirmed rapid inhibition of BCMA TurboCAR T™ cells by the protein tyrosine kinase inhibitor dasatinib, which has been shown to interfere with LCK activity. The prolonged persistence and antitumor responses seen in preclinical models along with a favorable safety profile of BCMA TurboCAR™ T cells support clinical investigation of ALLO-605 in relapsed or refractory multiple myeloma."

IO Biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • CD20 • CD52 • MPL

"$ALLO ALLO-605, a BCMA "TurboCAR" providing a separate signal 3. Via Cesar Sommer #ASH20" (@JacobPlieth)

Allogene Therapeutics Presents Preclinical Findings Supporting ALLO-605, the First Anti-BCMA TurboCAR T Cell Therapy, at the 62nd Meeting of the American Society of Hematology (GlobeNewswire) - "Results from the preclinical studies demonstrated that ALLO-605 showed enhanced cytokine secretion, polyfunctionality, improved serial killing activity in vitro, and enhanced eradication of tumors in animal models of myeloma...We are eager to bring ALLO-605 into the clinic and anticipate filing our first IND utilizing this novel technology in the first half of 2021."

IND • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Allogene Therapeutics Reports Third Quarter 2020 Financial Results (Allogene Therapeutics Press Release) - “Enrollment Ongoing in Phase 1 Trials of ALLO-501 (ALPHA), ALLO-501A (ALPHA2) and ALLO-715 (UNIVERSAL); Initial Phase 1 Results from the UNIVERSAL Trial in Relapsed/Refractory Multiple Myeloma to be Presented at a Medical Meeting in Q4 2020; In 1H 2021, Initial ALLO-501A Data and Updated ALLO-501 Results in Non-Hodgkin Lymphoma are Planned in Preparation for a Potential Pivotal Study Initiation of ALLO-501A in 2021; Three Investigational New Drug (IND) Applications to be Submitted; Two in Q4 2020 with ALLO-316, an Anti-CD70 AlloCAR T™, in Renal Cell Carcinoma and ALLO-715 in Combination with Nirogacestat in Relapsed/Refractory Multiple Myeloma, and One in 2021 with ALLO-605, the First TurboCAR™ Targeting BCMA.”

IND • New trial • P1 data • Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma

Allogene Therapeutics Announces Oral Presentation of Initial Results from its Phase 1 Dose Escalation Study of ALLO-715 in Relapsed/Refractory Multiple Myeloma at the 62nd Annual Meeting of the American Society of Hematology (GlobeNewswire) - "Preclinical Data Will Also be Presented on ALLO-605, a BCMA TurboCAR T™ Cell Therapy and ALLO-316 Targeting CD70 in Acute Myeloid Leukemia"

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Allogene Therapeutics Reports Second Quarter 2020 Financial Results (GlobeNewswire) - "Anti-BCMA AlloCAR T Program…ALLO-715 UNIVERSAL Phase 1 Trial…The trial continues to enroll patients with initial data anticipated in Q4 2020. ALLO-715 + nirogacestat: An Investigational New Drug (IND) application is expected to be submitted in the second half of 2020 to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM. ALLO-605 (TurboCAR™): In 2021, an IND is expected to be submitted for the Company’s first TurboCAR candidate, ALLO-605, an investigational BCMA-directed AlloCAR T therapy for MM."

IND • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Allogene Therapeutics reports first quarter 2020 financial results (GlobeNewswire) - "The ALLO-715 Phase 1 UNIVERSAL trial in patients with relapsed/refractory MM, which utilizes ALLO-647 as part of the lymphodepletion platform, is enrolling patients with initial data anticipated in Q4 2020; A trial to evaluate ALLO-715 in combination with SpringWorks’ investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed/refractory MM is on track to begin in the second half of 2020; The Company plans to submit an Investigational New Drug (IND) application for its first TurboCAR candidate, ALLO-605, a BCMA-directed AlloCAR T therapy for MM, in 2021."

Enrollment status • IND • New P2 trial • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology