bbT369 / Regeneron - LARVOL DELTA

CRC-403: A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=15 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=50 ➔ 15 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Enrollment change • Enrollment closed • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

CRC-403: A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: 2seventy bio | Trial primary completion date: Dec 2023 ➔ Aug 2024

CAR T-Cell Therapy • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

Regeneron Announces Formation of Regeneron Cell Medicines with the Acquisition of 2seventy bio Platforms and Preclinical and Clinical Programs (GlobeNewswire) - "Regeneron Pharmaceuticals, Inc...today announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization rights to its pipeline of investigational novel immune cell therapies, along with its discovery and clinical manufacturing capabilities. 2seventy bio employees who support the acquired programs will join Regeneron Cell Medicines, a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology....Under the terms of the new agreement, Regeneron will acquire full development and commercialization rights of 2seventy bio’s preclinical and clinical stage pipeline and will assume ongoing program, infrastructure and personnel costs related to these programs. There will be an upfront payment of $5 million and a single milestone payment from Regeneron to 2seventy bio for the first major market approval of the first approved product."

M&A • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

2seventy bio Announces Strategic Restructuring to Prioritize Growth of Abecma, Streamline Pipeline Advancement and Preserve Financial Runway (Businesswire) - "Given the anticipated pace of accrual and treatment, the Company expects to present the first data from the bbT369 study at a medical meeting in 2024....MUC-16 program in ovarian cancer (Regeneron partnership): IND submission is on track and anticipated by the end of 2023. MAGE-A4 T cell receptor (TCR) program in solid tumors (led by JW Therapeutics): Led by JW Therapeutics, initiation of an investigator-initiated study in China is ahead of schedule and anticipated by end of 2023."

IND • New trial • P1/2 data • Diffuse Large B Cell Lymphoma • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress (Businesswire) - "Second quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $115 million. Based on BMS reporting an expected decline in Abecma sales in the third quarter, the Company believes Abecma will achieve the lower end of U.S. revenue guidance of $470-570 million....Update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023. Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron anticipated by end of 2023. Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023."

Commercial • IND • New trial • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

2seventy bio Presents Broad Range of New Data Highlighting Novel Approaches Across its Cell Therapies Portfolio (Businesswire) - "2seventy bio, Inc...today announced new data featuring novel approaches combining the company’s platform CAR T cell and T cell receptor technology and unique cell therapy engineering capabilities to potentially enhance treatment potency in a range of cancers. The data were shared in three presentations at this year’s American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in Los Angeles, California....The data demonstrated that the CBLB gene edit significantly enhanced the activity of the bbT369 CAR T cells across each of the in vitro model systems tested. bbT369 T cells also drove greater T cell expansion and durable tumor control compared with unedited controls in vivo using a xenograft NSG mouse model."

Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

bbT369, a Clinical-Stage Dual-Targeted and CBLB Gene Edited Autologous CAR T Product for Non-Hodgkin Lymphoma, Shows Edit Driven Enhanced Activity in Preclinical In Vitro and In Vivo Models (ASGCT 2023) - P1/2 | "In addition, we show that bbT369 T cells drive greater T cell expansion and durable tumor control compared with unedited controls in vivo using a xenograft NSG mouse model. Collectively, the data support the potential for bbT369 to provide deeper and more durable responses in NHL patients including those with more challenging disease characteristics."

IO biomarker • Preclinical • Hematological Malignancies • Immune Modulation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CBL • CBLB • CD79A • PD-L1 • TGFB1

2seventy bio Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Progress (Businesswire) - “PIPELINE: Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023; Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia by the end of 2023; Submission of an IND for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron by end of 2023; Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors by end of 2023.”

IND • New trial • P1 data • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

CRC-403: A Phase 1/2 Study of bbT369, a Dual CD79a and CD20 Targeting CAR T Cell Drug Product with a Gene Edit, in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (ASH 2022) - P1/2 | "The starting dose of bbT369 is 50x106 CAR+ T cells and a BOIN design is being used for dose escalation/de-escalation decisions during the study. Upon establishment of the RP2D, the phase 2 portion will begin enrollment."

CAR T-Cell Therapy • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD79A

2seventy bio Reports Third Quarter Financial Results and Recent Operational Progress (Businesswire) - "2seventy bio’s clinical studies of DARIC-33 in acute myeloid leukemia (AML) and bbT369 in B cell non-Hodgkin lymphoma (B-NHL) are open and enrolling. We plan to share clinical data from these programs in the future. The company continues to execute pre-investigational new drug (IND) work to support a MUC-16 IND in 2023."

IND • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

CRC-403: A phase 1/2 study of bbT369, a dual targeting CAR T-cell drug product with a gene edit, in relapsed and/or refractory B-cell non-Hodgkin lymphoma (NHL). (ASCO 2022) - P1/2 | "The starting dose of bbT369 will be 50x106 CAR+ T cells and a BOIN design will be used for dose escalation/de-escalation decisions during the study. Upon establishment of the RP2D, the phase 2 portion will begin enrollment."

CAR T-Cell Therapy • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CBL • CBLB • CD19 • CD79A

bbT369, a dual-targeted and CBLB gene-edited autologous CART product, demonstrates anti-lymphoma activity in preclinical mouse models (AACR 2022) - "Furthermore, while a fraction of mice (3/5) receiving the unedited anti-CD79a/CD20 dual-targeting CAR T cells experienced late relapses (between 60-80 days following initial tumor clearance), all mice (n=5) receiving bbT369 were fully protected from late relapses (up to day 104 of follow-up). Collectively, the data support a first-in-human trial for bbT369 to evaluate initial safety and efficacy in NHL patients."

IO biomarker • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CBL

2seventy bio Presents New Preclinical Data on bbT369, an Investigational Dual-Targeting Gene-Edited CAR T Cell Therapy, at the AACR Annual Meeting (Businesswire) - "2seventy bio...will present preclinical data on bbT369, an investigational novel CD79a/CD20 dual-targeting CBLB gene edited CAR T cell therapy at the American Association for Cancer Research (AACR) Annual Meeting 2022....bbT369 resulted in three-fold increased cell expansion and prevention of late relapses in B-NHL mouse models compared with a non-gene edited control....CRC-403 (NCT05169489), an open-label, multi-site Phase 1/2 dose-escalation study, is currently enrolling patients....Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety is expected in 2H 2022."

P1/2 data • Preclinical • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

2seventy bio Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Operational Progress (Businesswire) - "KarMMa-2 study in high-risk multiple myeloma proof-of-concept data in 2022, KarMMa-3 study in 3L+ registrational data in 2023 with potential FDA approval in 2023-2024...Presentation of preclinical data from bbT369 program in B-NHL at AACR Annual Meeting 2022. Infusion of first patients in CRC-403 study of bbT369 in B-NHL in 2022. Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety in 2H 2022. Infusion of first patients in PLAT-08 study of SC-DARIC33 in AML in 2022. Initial assessment of feasibility of SC-DARIC33 drug product manufacturing and drug regulated anti-CD33 activity in 2H 2022."

FDA event • P2 data • P3 data • Preclinical • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: 2seventy bio | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

2seventy bio Shares Key Milestones and Business Updates for 2022 (Businesswire) - "UPCOMING ANTICIPATED MILESTONES: ABECMA - Anticipate $250-300M total U.S. revenue in 2022. Increasing manufacturing capacity throughout 2022. KarMMa-2 study in 2L proof-of-concept data in 2022. KarMMa-3 study in 3L+ registrational data in 2023; Pipeline: Infusion of first patients in PLAT-08 study of SC-DARIC33 in AML in 2022. Initial assessment of feasibility of SC-DARIC33 drug product manufacturing and drug regulated anti-CD33 activity in 2H 2022. Infusion of first patients in CRC-403 study of bbT369 in B-NHL in 2022. Initial assessment of feasibility of bbT369 drug product manufacturing and patient safety in 2H 2022."

Clinical data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 1/2 Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL) (clinicaltrials.gov) - P1/2; N=50; Not yet recruiting; Sponsor: 2seventy bio

CAR T-Cell Therapy • New P1/2 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

2seventy bio Reports Third Quarter Financial Results and Recent Operational Progress (Businesswire) - "UPCOMING ANTICIPATED MILESTONES: (i) Acceptance of investigational new drug (IND) application for bbT369 in bNHL by the end of 2021; (ii) Presentation of new preclinical data from the SC-DARIC33 program at the 63rd ASH Annual Meeting in December 2021; (iii) Presentation of clinical data from the ongoing CRB-402 study of bb21217 at the 63rd ASH Annual Meeting in December 2021."

IND • P1 data • Preclinical • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

2seventy bio Completes Spin Transaction and Launches Innovative Immuno-oncology Cell Therapy Company (Businesswire) - "Acute Myeloid Leukemia (AML)/SC-DARIC33: The initiation of an upcoming Phase 1 study of SC-DARIC33 in relapsed/refractory pediatric and young adult AML in collaboration with Seattle Children’s Therapeutics will be a first-in-human investigation of 2seventy bio’s proprietary Dimerizing Agent Regulated Immunoreceptor Complex (DARIC) T cell platform; B-cell non-Hodgkins Lymphoma (bNHL)/bbT369: The initiation of an upcoming Phase 1 dose-escalation study in patients with relapsed and refractory bNHL will be a proof-of-concept study of 2seventy bio’s proprietary gene editing platform, dual-targeting strategies and split co-stimulation signaling technology."

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology