BEAM-201 / Beam Therap - LARVOL DELTA

BEAM-201 for the Treatment of Relapsed and/or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL): Initial Data from the Phase (Ph) 1/2 Dose-Exploration, Dose-Expansion, Safety, and Efficacy Study of Multiplex Base-Edited Allogeneic Anti‑CD7 CAR-T-Cells (ASH 2024) - P1/2 | "Alemtuzumab (Alz), a CD52-targeting monoclonal antibody, has been used with allogeneic CAR-T-cells to facilitate robust expansion and persistence...BEAM-201 DE was performed across 4 dose levels (DLs; DL-1 60×106 cells; DL1 180×106 cells; DL2 360×106 cells; DL3 500×106 cells) in 2 parallel cohorts using either a fludarabine (30 mg/m2 ×4 days)/cyclophosphamide (500 mg/m2 ×3 days) (Flu/Cy) or Flu/Cy + Alz (20 mg ×1 day) lymphodepletion regimen at the investigator's discretion...Early evidence of efficacy with CAR-T-cell doses <200 million, as measured by CRi/CR in 2/3 Ps, is very encouraging. Updated data will be presented."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD52 • PD-1 • PD-L1

24CT015: Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Stephan Grupp MD PhD | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

24CT015: Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Stephan Grupp MD PhD

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P1/2 | N=5 | Active, not recruiting | Sponsor: Beam Therapeutics Inc. | N=102 ➔ 5

Enrollment change • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma • CD7

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P1/2 | N=102 | Active, not recruiting | Sponsor: Beam Therapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2031 ➔ Dec 2026 | Trial primary completion date: Dec 2031 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • T-cell Acute Lymphoblastic Lymphoma • CD7

BEAM-201 Poster Presentation (GlobeNewswire) - P1/2 | N=102 | NCT05885464 | Sponsor: Beam Therapeutics Inc. | "Key Highlights: Initial data as of a June 11, 2024, data cut in 3 patients treated with BEAM-201 show a safety profile consistent with underlying disease, lymphodepletion and AEs associated with CAR-T therapy; A complete response (CRi/CR) was demonstrated in 2 of 3 patients at CAR-T cell doses <200 million. Both patients achieving a CRi/CR were deemed suitable for stem cell transplant following therapy; The presentation at ASH will include additional data with more patients and longer follow-up."

P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma

Beam Therapeutics Reports Pipeline Updates and Second Quarter 2024 Financial Results (GlobeNewswire) - "Key Anticipated Milestones....Initial data from the Phase 1/2 clinical trial of BEAM-201, a multiplex-edited allogeneic CAR-T product candidate for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL), have been submitted for presentation at the ASH Annual Meeting."

P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Beam Therapeutics Highlights Progress Across Base Editing Portfolio and Outlines 2024 Anticipated Milestones (GlobeNewswire) - "Enrollment in the company’s Phase 1/2 clinical trial of BEAM-201, a multiplex-edited allogeneic CAR-T product candidate, is ongoing for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL). Beam expects to report an initial clinical dataset for BEAM-201 in the second half of 2024."

P1/2 data • Trial status • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Beam Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of BEAM-201 in Relapsed, Refractory T-ALL/T-LL (GlobeNewswire) - "Beam Therapeutics...announced that in August, the first patient was treated with BEAM-201, a quadruplex-edited allogeneic CAR-T cell investigational therapy. BEAM-201 is being evaluated in a Phase 1/2 clinical study for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL), a severe disease affecting children and adults."

Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma

Beam Therapeutics Reports Pipeline Updates and Second Quarter 2023 Financial Results (GlobeNewswire) - "Beam Therapeutics Inc...today reported second quarter 2023 financial results and provided an update on its clinical and pipeline progress...The first patient has consented and is expected to be dosed in the third quarter of 2023...The company plans to share updates on these efforts by year-end 2023...Submit a regulatory application for authorization to initiate clinical trials for BEAM-302 in the first quarter of 2024...Cash, cash equivalents and marketable securities were $1.1 billion as of June 30, 2023, as compared to $1.1 billion as of December 31, 2022....Beam expects that its cash, cash equivalents and marketable securities as of June 30, 2023, will enable the company to fund its anticipated operating expenses and capital expenditure requirements at least into 2025."

Commercial • IND • Trial status • Acute Lymphocytic Leukemia • Alpha-1 Antitrypsin Deficiency • Hematological Malignancies • Leukemia • Metabolic Disorders • Oncology • T Acute Lymphoblastic Leukemia

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Beam Therapeutics Inc. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • CD7

A Study Evaluating the Safety and Efficacy of BEAM-201 in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: Beam Therapeutics Inc.

CAR T-Cell Therapy • IO biomarker • New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T Cell Non-Hodgkin Lymphoma • CD7

"$BEAM just went through this exact process for $BEAM-201" (@GeneInvesting)

Beam Therapeutics Reports Progress Across Base Editing Portfolio and Outlines Key Anticipated Milestones (GlobeNewswire) - "The company has initiated a first-in-human Phase 1/2 clinical trial to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL) and expects to dose the first patient by mid-2023. The Phase 1 portion of the trial is expected to include up to 48 patients between the ages of 18 and 50, followed by a Phase 2 portion with approximately 48 patients....Beam believes that multiplex base editing, with its high potency, efficiency in editing and lack of double-strand breaks, is well suited for making such highly engineered cells, and anticipates providing additional updates on this research in 2023."

Commercial • New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Beam Therapeutics Announces FDA Has Lifted the Clinical Hold on the Investigational New Drug Application for BEAM-201 (GlobeNewswire) - "Beam Therapeutics...announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the Investigational New Drug (IND) application for BEAM-201 for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL). BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T-cell development candidate....'We look forward to providing updates on next steps for the program in 2023'."

IND • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

"$BEAM FDA Lifts Clinical Hold on BEAM-201 IND." (@BioStocks)

Clinical • FDA event

Beam Therapeutics Announces FDA Clinical Hold on BEAM-201 IND Application (GlobeNewswire) - "Beam Therapeutics...announced that on Friday, July 29, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the BEAM-201 Investigational New Drug (IND) application for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL) has been placed on clinical hold. BEAM-201 is a potent and specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate. The BEAM-201 IND was submitted at the end of June. The FDA indicated they will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending discussion with the FDA."

FDA event • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

Beam Therapeutics Reports Pipeline and Business Highlights, Planned 2022 Milestones and Fourth Quarter and Full Year 2021 Financial Results (GlobeNewswire) - "Key 2022 Anticipated Milestones: Ex Vivo HSC Programs - Enroll the first subject in the Phase 1/2 clinical trial of BEAM-101 for the treatment of SCD, which is referred to as the BEACON-101 trial, in the second half of 2022. Submit an investigational new drug (IND) application for BEAM-102 for the treatment of SCD in the second half of 2022; Ex Vivo T Cell Programs - Submit an IND application for BEAM-201 for the treatment of relapsed/refractory T cell acute lymphoblastic leukemia/T cell lymphoblastic lymphoma (T-ALL/TLL) in the second half of 2022. Nominate a second CAR T development candidate in 2022."

IND • Hematological Malignancies • Oncology • T Acute Lymphoblastic Leukemia