JWTCR001 / Medigene, Regeneron, JW (Cayman) Therap - LARVOL DELTA

Medigene Receives Milestone Payment from Regeneron Pharmaceuticals, Inc. (GlobeNewswire) - "Medigene AG...announced a USD $1 million milestone payment from Regeneron Pharmaceuticals, Inc. was triggered. Regeneron purchased the MAGE-A4-TCR program as part of its acquisition of 2seventy bio Inc.’s pre-clinical and clinical oncology and autoimmune cell therapy pipeline, which closed in April 2024. The payment was triggered by a development milestone for a trial in China led by JW Therapeutics (also a prior collaborator of 2seventy bio, Inc.) of Regeneron’s MAGE-A4 cell therapy, which contains a Medigene generated T cell receptor (TCR) targeting MAGE-A4."

Financing • Oncology • Solid Tumor

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

MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Peking University

New P1 trial • Oncology • 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 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

Medigene AG Receives $3 Million Milestone Payment from 2Seventy Bio (Market Screener) - "Medigene AG announced that it has received a $3 million milestone payment from its partner 2seventy bio as part of its T cell receptor agreement in cancer immunotherapy, and which may lead to further potential milestone payments in the future. This payment follows the strategic alliance between 2seventy bio, and JW Therapeutics, with the initial focus on the development of 2seventy bio's MAGE-A4 program which employs a highly potent TCR discovered in collaboration with Medigene's proprietary end-to-end technology platform."

Financing • Oncology

JW Therapeutics and 2seventy bio Announce Strategic Partnership to Accelerate the Research and Development of T Cell-based Immunotherapies (PRNewswire-Asia) - "JW Therapeutics...and 2seventy bio...announced a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy products in the Chinese mainland, Hong Kong (China), and Macao (China). The initial focus of the collaboration is 2seventy's MAGE-A4 TCR program in solid tumors which is being developed as part of collaboration with Regeneron. MAGE-A4 is a member of the MAGE family of cancer-testis antigens expressed in a number of solid tumor types....Under the terms of the agreement, 2seventy will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China)."

Licensing / partnership • Oncology • Solid Tumor

2seventy bio and JW Therapeutics Announce Strategic Partnership to Accelerate the Research and Development of T Cell-based Immunotherapies (Businesswire) - "2seventy bio, Inc...and JW Therapeutics...today announced a strategic alliance to establish a translational and clinical cell therapy development platform designed to more rapidly explore T cell-based immunotherapy therapy products in the Chinese mainland, Hong Kong (China), and Macao (China)....The initial focus of the collaboration is 2seventy bio’s MAGE-A4 TCR program in solid tumors which is being developed as part of a collaboration with Regeneron....Under the terms of the agreement, 2seventy bio will grant JW Therapeutics a license for the MAGE-A4 cell therapy in the Chinese mainland, Hong Kong (China), and Macao (China). JW Therapeutics will be responsible for development, manufacturing, and commercialization within China."

Licensing / partnership • Oncology • Solid Tumor

PUBLICATION OF RESEARCH ON CO-RECEPTOR INDEPENDENT MAGE-A4-SPECIFIC T CELL RECEPTOR (MediGene Press Release) - "Medigene AG...announces the publication of a peer-reviewed paper entitled, 'Development of a CD8 co-receptor independent T cell receptor specific for tumor-associated antigen MAGE-A4 for next generation T-cell-based immunotherapy' covering preclinical research on a T cell receptor (TCR) specific for a peptide derived from the MAGE-A4 protein in the Journal for Immunotherapy of Cancer...In preclinical research, the TCR has a favorable activity profile and superior in vivo potency compared to other specific MAGE-A4 TCRs tested (including those isolated from HLA-A2-positive donors who have tolerized T cell repertoires to self-antigens presented by HLA-A2). This non-mutated, high avidity MAGE-A4-specific TCR is CD8 co-receptor-independent, allowing effector functions to be elicited in CD4 helper T cells transduced to express the TCR."

Preclinical • Oncology

Medigene's MAGE-A4-specific TCR-Ts detect and fight cancer cells independent of CD8 co-receptor (MediGene Press Release) - "Medigene AG...pleased to present a poster detailing pre-clinical research related to its CD8 co-receptor independent, MAGE-A4-specific T cell receptor (TCR) at the Society for Immunotherapy of Cancer 35th Annual Meeting (SITC 2020) being held virtually on 9-14 November 2020."

Preclinical

MEDIGENE'S MAGE-A4-SPECIFIC TCR-TS DETECT AND FIGHT CANCER CELLS INDEPENDENT OF CD8 CO-RECEPTOR (MediGene Press Release) - "The TCR was demonstrated preclinically to have a favorable safety profile and superior in vivo potency compared to TCRs isolated from an HLA-A2-positive donor (bearing a tolerized T cell repertoire to self-antigens). This non-mutated high avidity TCR was also CD8 co-receptor-independent, allowing effector functions to be elicited in CD4 helper T cells."

Preclinical • Oncology