RG6540 / Roche, Genentech - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Withdrawn | N=162 ➔ 0

Enrollment change • Trial withdrawal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

P-CD19CD20-ALLO1-001: P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Poseida Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Genentech, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Genentech, Inc. | Initiation date: Feb 2026 ➔ Jun 2026

Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting CD19 and CD20 with Superior Efficacy over Single-Target Products (ASH 2024) - P1 | "Clinical data from Poseida and others have demonstrated safety and efficacy advantages associated with TSCM CAR-T, including for P-BCMA-ALLO1, our BCMA-targeting allogeneic CAR-T for Relapsed/Refractory Multiple Myeloma (NCT04960579). P-CD19CD20-ALLO1 CAR-T cells were superior to the CD19-targeting CAR-T product. P-CD19CD20-ALLO1, a dual-targeting, fully allogeneic TSCM-rich CAR-T product for CD19 and CD20-positive B-cell malignancies, demonstrates robust antigen-specific activity against DLBCL and CLL models and outperforms its single-targeting counterparts even in the presence of only a single antigen on target cells."

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Multiple Myeloma • Oncology • B2M • CD19 • FASLG • GZMA • IFNG

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2032 ➔ Aug 2032 | Trial primary completion date: Feb 2032 ➔ Aug 2032

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

P-CD19CD20-ALLO1: A TSCM-PREDOMINANT ALLOGENEIC CAR-T THERAPY TARGETING CD19 and CD20 FOR B-CELL MALIGNANCIES DEMONSTRATES ADVANTAGES BEYOND PREVENTING ANTIGEN ESCAPE (ICML 2025) - P1 | "Clinical data from TSCM-rich CAR-T P-BCMA-ALLO1, our BCMA-targeting allogeneic CAR-T for R/R multiple myeloma (NCT04960579), have demonstrated favorable safety and efficacy, likely related at least in part to the undifferentiated CAR-T. P-CD19CD20-ALLO1, a dual-targeting, fully allogeneic TSCM-rich CAR-T product for CD19 and CD20-positive B-cell malignancies, demonstrates robust antigen-specific activity against diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL) models as well as the phenotype and function associated with TSCM. P-CD19CD20-ALLO1 is currently being investigated in an open-label, multicenter Phase 1 study in subjects with R/R B cell malignancies (NCT06014762) and for autoimmune diseases."

IO biomarker • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • B2M • CD19

A MULTICENTER, OPEN-LABEL, Ph 1 STUDY TO ASSESS THE SAFETY OF P-CD19CD20-ALLO1, AN ALLOGENEIC CAR-T CELL THERAPY, IN SUBJECTS WITH RELAPSED/REFRACTORY B CELL MALIGNANCIES (ICML 2025) - P1 | "Several lymphodepletion (LD) dosing regimens with cyclophosphamide and fludarabine are also being evaluated for expansion of P-CD19CD20-ALLO1. After receiving LD for 3 days followed by a 2-day break, patients receive a single infusion of P-CD19CD20-ALLO1 and are followed for safety and efficacy. The dose escalation portion of the study is actively enrolling patients, and an expansion phase will follow."

CAR T-Cell Therapy • Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • B2M • CD19 • CD20

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Genentech, Inc.

New P1 trial • CNS Disorders • Multiple Sclerosis

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1 | N=162 | Not yet recruiting | Sponsor: Genentech, Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Poseida Therapeutics Highlights…Preclinical Data for Dual CAR-T P-CD19CD20-ALLO1 at the 66th American Society of Hematology (ASH) Annual Meeting (PRNewswire) - "New preclinical data included in the poster presentation show that compared to CD19-single targeting or CD20-single targeting CAR-T cells, P-CD19CD20-ALLO1: Achieved higher and more durable killing of tumor cells over three rechallenges, even in the presence of only one tumor antigen. Exhibited higher cytotoxicity. Produced higher and more sustained levels of effector cytokines (IL-2, IFN-γ, sFasL, Granzyme A and Granulysin) that play an important role mediating the immune system response to cancers. Showed higher in vivo antitumor efficacy than the CD19-single targeting CAR-T cells."

Preclinical • Hematological Malignancies

Poseida Therapeutics Hosts Cell Therapy R&D Day Highlighting Its Innovative...Preclinical Pipeline (PRNewswire) - "...the Company will highlight its emerging pipeline programs for hematologic malignancies: P-CD19CD20-ALLO1 is the Company's first dual CAR-T program targeting CD19 and CD20 for the treatment of B-cell malignancies in collaboration with Roche. New preclinical data demonstrate that P-CD19CD20-ALLO1 delivers high in vitro potency and strong in vivo antitumor activity for either CD19 or CD20 single-positive target cells, as well as double-positive targets....New preclinical data demonstrate P-CD70-ALLO1's robust anti-AML effect, with no toxicity to hematopoietic stem cells. In addition, there is a growing body of clinical and preclinical evidence that targeting CD70 with cell therapy may be an effective treatment for solid tumors."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Poseida Therapeutics to Present Clinical and Preclinical Data on Investigational Allogeneic CAR-T Cell Therapies at SITC 2024 and ASH 2024 (PRNewswire) - "Poseida Therapeutics...announced new preclinical data on allogeneic CAR+TCR-T cells rich in stem cell memory T cells (T_SCM), along with platform enhancements aimed at enhancing potency and improving targeting of solid tumors, will be presented at the Society for Immunotherapy of Cancer (SITC)...Additionally, the Company announced presentations at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, which will be held December 7-10 in San Diego. To further characterize compelling emerging P-BCMA-ALLO1 clinical data, additional profiling of patient responses from the optimized lymphodepletion arm (Arm C) of the P-BCMA-ALLO1 Phase 1 study, along with data first presented at the 21st International Myeloma Society (IMS) Annual Meeting will be highlighted as a poster presentation. In addition, preclinical data from the ongoing Phase 1 trial of P-CD19CD20-ALLO1 in patients with B-cell malignancies will be delivered as a poster presentation."

Clinical data • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Poseida Therapeutics Hosts Cell Therapy R&D Day Highlighting Its Innovative Clinical…Pipeline (PRNewswire) - "Poseida Therapeutics...announced plans to share progress across its clinical- and earlier-stage pipeline of differentiated T stem cell memory cells (TSCM)-rich allogeneic CAR-T therapies in oncology and autoimmune diseases during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT....Poseida will provide an overview of recently reported interim Phase 1 results for P-BCMA-ALLO1, its lead CAR-T program targeting BCMA for the treatment of multiple myeloma. New preclinical data suggest that P-BCMA-ALLO1 effectively targets mutations that are known to arise in patients with relapse after prior anti-BCMA therapies. P-BCMA-ALLO1 is part of Poseida's collaboration with Roche and is currently enrolling a Phase 1b dose expansion study, which will be outlined in the presentation...P-CD19CD20-ALLO1 is the Company's first dual CAR-T....A Phase 1 clinical trial is enrolling patients with selected B-cell malignancies, with initial clinical data anticipated in 2025."

Clinical data • Hematological Malignancies • Multiple Myeloma • Oncology

Roche enters into a definitive agreement to acquire Poseida Therapeutics, including cell therapy candidates and related platform technologies (GlobeNewswire) - "Roche...announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc....Based in San Diego, California, Poseida’s R&D portfolio includes pre-clinical and clinical-stage off-the-shelf (also referred to as allogeneic) CAR-T therapies across several therapeutic areas including haematological malignancies, solid tumours, and autoimmune disease, as well as manufacturing capabilities and technology platforms....Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of Poseida common stock at a price of US $9.00 per share in cash at closing plus a non-tradeable CVR to receive certain milestone payments of up to an aggregate of US $4.00 per share in cash, representing a total equity value of approximately US $1.0 billion at closing and representing a total deal value of up to US $1.5 billion."

M&A • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Poseida Therapeutics Provides Updates and Financial Results for the Third Quarter of 2024 (PRNewswire) - "Continued to enroll patients in the Phase 1 clinical trial of P-CD19CD20-ALLO1. In light of the competitive environment for therapies targeting CD19 and CD20, Poseida and Roche anticipate providing initial clinical data from the trial in 2025 once a more complete dataset of the program is available."

Enrollment status • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma

Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2024 (PRNewswire) - "Upcoming Milestones: P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM): new data anticipated for presentation at the International Myeloma Society 21st Annual Meeting, being held September 25-28, 2024, in Rio de Janeiro. Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche; P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024; P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024, subject to coordination with Roche."

P1 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Poseida Therapeutics Provides Updates and Financial Results for the First Quarter of 2024 (PRNewswire) - "Anticipated Milestones: (i) P-BCMA-ALLO1 in RRMM: clinical update planned for the second half of 2024 subject to coordination with Roche; (ii) P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024; (iii) P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024 subject to coordination with Roche."

P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Multiple Myeloma • Solid Tumor

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Poseida Therapeutics, Inc. | Initiation date: Jan 2024 ➔ Apr 2024

CAR T-Cell Therapy • Trial initiation date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD5 • FCER2

Poseida Therapeutics Provides Updates and Financial Results for the Fourth Quarter and Full Year 2023 (Poseida Therap Press Release) - "P-CD19CD20-ALLO1: Following the initiation of the Phase 1 trial targeting B-cell malignancies in late 2023, the Company expects to provide an interim data update in the second half of 2024, subject to coordination with Roche."

P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Poseida Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | N=70 ➔ 100

CAR T-Cell Therapy • Enrollment change • Enrollment open • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD5 • FCER2

Poseida Therapeutics Provides Updates and Financial Results for the Third Quarter of 2023 (PRNewswire) - "Poseida Therapeutics, Inc...today announced updates and financial results for the third quarter ended September 30, 2023...Based upon substantial progress in its P-BCMA-ALLO1 and P-CD19CD20-ALLO1 programs, the Company is announcing today that certain payments as well as the expected timing of achievement of upcoming milestones, have been accelerated to reflect progress in the programs and better align with expected upcoming further clinical development and manufacturing needs and timelines....Poseida expects to dose the first patient with P-CD19CD20-ALLO1 in early 2024."

Commercial • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Poseida Therapeutics, Inc.

CAR T-Cell Therapy • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD5 • FCER2

Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-CD19CD20-ALLO1, an Allogeneic Dual CAR-T Cell Therapy for B-Cell Malignancies (PRNewswire) - "Poseida Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-CD19CD20-ALLO1, the Company's first allogeneic dual CAR-T cell product candidate, which targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies and is being developed in partnership with Roche....P-CD19CD20-ALLO1 will be evaluated in a Phase 1 multi-center, open-label, dose-escalation study that will enroll up to 70 adult patients with relapsed or refractory B-cell malignancies."

IND • New P1 trial • Hematological Malignancies • Oncology