SY-104 / Syena, UT MD Anderson Cancer Center - LARVOL DELTA

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 (clinicaltrials.gov) - P1 | N=44 | Suspended | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Suspended

Metastases • Trial suspension • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A • SSX1

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Suspended ➔ Recruiting

Enrollment open • Metastases • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A • SSX1

Replay, MD Anderson Venture Syena Bets on NK Cells to Bring TCR Therapy to Solid, Blood Cancers (Precision Medicine Online) - "After announcing earlier this month that its first investigational cell therapy entered clinical trials in multiple myeloma, Replay and MD Anderson Cancer Center's new joint effort Syena is already considering which patient populations and targets to go after next with the natural killer cell treatment....Any day, the firm expects to begin a trial evaluating the same therapy in sarcoma patients, and later this year, it will begin testing a similar therapy that targets PRAME."

New trial • Oncology • Sarcoma • Solid Tumor

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 (clinicaltrials.gov) - P1 | N=44 | Suspended | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Suspended

Metastases • Trial suspension • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A • SSX1

Replay’s cell therapy product company Syena announces first patient dosed in Phase 1/2 study of TCR-NK cell therapy for multiple myeloma (GlobeNewswire) - "Replay...announced that the first patient has been dosed in the Phase 1/2 study of NY-ESO-1 TCR/IL-15 NK, an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed or refractory multiple myeloma....The Phase 1/2 clinical study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with relapsed or refractory multiple myeloma. It will be administered following lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy). The study will enrol up to 44 patients in total."

Trial status • Multiple Myeloma

Replay and its engineered NK cell therapy company Syena announce exclusive licensing agreement with National Institutes of Health for TCRs targeting cancer neoantigens (GlobeNewswire) - "Replay...announced that it has entered into an exclusive, worldwide license agreement with the National Institutes of Health (NIH) for intellectual property related to a library of T-Cell Receptors (TCRs) directed against multiple cancer neoantigens. These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies....Preclinical development of the new TCR-NK programs will advance alongside the clinical development of Syena’s lead engineered TCR-NK cell therapy candidate targeting NY-ESO-1, and the PRAME program announced today. First-in-human Phase 1 studies of NY-ESO-1 TCR/IL-15 NK in patients with advanced synovial sarcoma, myxoid/round cell liposarcoma and relapsed or refractory multiple myeloma, will commence in Q4 of this year."

Licensing / partnership • New P1 trial • Hematological Malignancies • Liposarcoma • Multiple Myeloma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

Phase I/II Randomized Trial of Cord Blood-derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Nov 2023

Enrollment open • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology • CTAG1B • HLA-A

Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Metastases • New P1 trial • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A • SSX1

Replay and MD Anderson announce FDA clearance of IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma (GlobeNewswire) - "Phase 1 study of NY-ESO-1 TCR/IL-15 NK for relapsed or refractory multiple myeloma, first TCR-NK clinical study in hematological malignancies, anticipated to commence Q3 2023....Replay...and The University of Texas MD Anderson Cancer Center ('MD Anderson'), today announced that the U.S. Food & Drug Administration (FDA) has issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed or refractory multiple myeloma. MD Anderson is the IND sponsor."

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

Replay and MD Anderson announce FDA clearance of IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for sarcoma (GlobeNewswire) - "Replay...and The University of Texas MD Anderson Cancer Center...announced that the U.S. Food & Drug Administration (FDA) has issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK, an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma. MD Anderson is the IND sponsor....The Phase 1/1b study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with synovial sarcoma and myxoid/round cell liposarcoma. It will be administered following lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy). Approximately 44 patients will be enrolled into the study, anticipated to commence in Q3 2023."

IND • New P1 trial • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

Replay’s Syena aims to be first in the clinic with TCR-NK therapy (Bioworld) - "Replay Holdings LLC said it will be first into the clinic with a T-cell receptor natural killer (TCR-NK) cancer immunotherapy, after forming its latest satellite company around technology from the University of Texas MD Anderson Cancer Center. No financial details were disclosed, but the newco, Syena, is funded to run a basket trial that will assess an NY-ESO-1-targeted TCR-NK in a number of hematological and solid tumors, and said it will start treating patients in the second half of 2023."

Clinical • Oncology • Solid Tumor

KKR-backed Replay and MD Anderson form new product company Syena to pioneer first-in-class TCR-NK cell therapy (GlobeNewswire) - "Replay...and The University of Texas MD Anderson Cancer Center, today announced the launch of Syena, a new oncology-focused product company pioneering T-cell receptor (TCR) natural killer (NK) cell therapies (TCR-NKs)....Based on the contributions of Replay and MD Anderson, Syena will build a pipeline of engineered cell therapies using its novel TCR-NK cell platform, licensed exclusively from MD Anderson. It is targeting a selection of validated cancer neoantigens, including NY-ESO-1, and additional undisclosed TCRs. The NY-ESO-1 program in hematological malignancies and solid tumors is anticipated to enter the clinic in Q2 2023....Syena will receive licenses to various Replay cell and genome engineering platform technologies."

Licensing / partnership • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor