CLN-978 / Cullinan Therap - LARVOL DELTA

Cullinan Therapeutics to Initiate Study of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Sjögren’s Disease in the United States (GlobeNewswire) - "Cullinan Therapeutics, Inc....today announced that the Company is initiating a study of CLN-978 in patients with Sjögren’s disease (SjD) in the U.S....The trial will enroll patients with active, moderate to severe Sjögren's disease who fulfill the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria and are positive for anti-SSA/RO antibodies and/or rheumatoid factor....CLN-978 is being studied in people with SLE in the U.S., Australia, and Europe."

New trial • Immunology

Cullinan Therapeutics Receives Approval from European Medicines Agency to Initiate Phase 1 Trial of CLN-978, a Bispecific CD19 T Cell Engager Administered Subcutaneously, in Patients with Rheumatoid Arthritis (GlobeNewswire) - "Cullinan Therapeutics, Inc...announced that the European Medicines Agency (EMA) approved the Company’s Clinical Trial Application (CTA) for CLN-978. The Phase 1 clinical trial will assess CLN-978 in patients with active, difficult-to-treat rheumatoid arthritis meeting the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria....Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025."

IND • New P1 trial • Rheumatoid Arthritis

IndEx-2: An in vitro model to evaluate the impact of target antigen density on antibody and immune therapeutics (AACR 2025) - "In the first, we have compared CLN978, a novel CD19- TCE developed for B-cell malignancies and autoimmune diseases, with Blinatumomab and demonstrated that the former retained its activity in terms of cytotoxicity and cytokine production at much lower levels of CD19 expression and estimate the threshold for each molecule in a cohort of 10 healthy donors. The tandem CAR exhibited enhanced cytotoxicity when either or both antigens were expressed, whereas the dual CAR required co-expression of both antigens for optimal T-cell activation. These results underscore IndEx-2's robustcapability to evaluate the influence of antigen density on therapeutic safety andefficacy, providing a powerful tool for the development of antibody-based and immune-targeting cancer therapies."

IO biomarker • Preclinical • Hematological Malignancies • Oncology • CD19 • CD22 • HER-2 • IFNG

Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "CLN-978 (CD19xCD3 T cell engager): The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025; The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025."

New P1 trial • P1 data • Trial status • Rheumatoid Arthritis • Systemic Lupus Erythematosus

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cullinan Therapeutics Inc. | Not yet recruiting ➔ Recruiting

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

CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases (ACR Convergence 2024) - P1 | "CLN-978 is a highly potent, SC-administered, CD19-directed TCE with both preclinical and clinical data providing a strong rationale for broad development in autoimmune diseases which benefit from B cell depletion."

Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

Cullinan will share details of global Phase 1b study in moderate to severe systemic lupus erythematosus (GlobeNewswire) - "Cullinan Therapeutics....will present...the study schema for a planned Phase 1b study in patients with moderate to severe systemic lupus erythematosus (SLE) will be presented at the annual meeting of the American College of Rheumatology (ACR), ACR Convergence 2024, being held in Washington, D.C., November 14-19....The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments...The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE....Initial clinical data are expected in the fourth quarter of 2025."

Clinical protocol • P1 data • Systemic Lupus Erythematosus

Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024 (GlobeNewswire) - "CLN-978 Preclinical Data: New in vitro preclinical data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in human peripheral blood mononuclear cells (PBMC) derived from patients with SLE (n=12) or rheumatoid arthritis (RA) (n=9) as compared to healthy volunteers (n=11)....'These new preclinical data further demonstrate that CLN-978 is a highly potent T cell engager. With the ability to be subcutaneously delivered, CLN-978 offers off-the-shelf convenience while achieving significant B cell depletion, supporting its potential as a promising new therapeutic option for autoimmune diseases...'"

Preclinical • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Cullinan Therapeutics to Present Preclinical Data for CLN-978, a CD19-directed T Cell Engager, at ACR Convergence 2024 (GlobeNewswire) - "Cullinan Therapeutics....today announced the upcoming presentation of preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, at American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024."

Preclinical • Immunology • Systemic Lupus Erythematosus

Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus (GlobeNewswire) - "Cullinan Therapeutics...announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE). The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent."

IND • Systemic Lupus Erythematosus

A Study of CLN-978, a CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

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

Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus (GlobeNewswire) - "The trial will be conducted in multiple sites in Australia as well as other countries around the world...Cullinan Therapeutics, Inc...received Human Research Ethics Committee (HREC) approval in Australia to initiate its global Phase 1 clinical trial to evaluate CLN-978, its CD19xCD3 bispecific T cell engager, for the treatment of systemic lupus erythematosus (SLE)."

New P1 trial • Lupus • Systemic Lupus Erythematosus

Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus (GlobeNewswire) - "Cullinan Therapeutics, Inc...shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE)."

IND • Immunology • Lupus • Systemic Lupus Erythematosus

A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Cullinan Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cullinan Therapeutics Announces Strategic Expansion into Autoimmune Diseases (GlobeNewswire) - "In a separate announcement, the company also announced a $280 million private placement. The proceeds from the private placement, combined with current cash, cash equivalents, short term investments and interest receivable, are expected to fund Cullinan's current operating plan into 2028.....The company plans to submit an investigational new drug application to study CLN-978 in patients with SLE in the third quarter of 2024 and is also planning for future development in other autoimmune diseases."

Financing • IND • Systemic Lupus Erythematosus

Correction: CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression. (PubMed, J Immunother Cancer) - No abstract available

Journal • Hematological Malignancies • Oncology • CD19

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study of CLN-978 (CD19XCD3XHSA) in Patients with Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL) (ASH 2023) - P1 | "Approximately 90 patients (30 in dose escalation and 60 in dose expansion) will be enrolled at approximately 6 sites in the U.S., reflecting both community and academic centers. The study is currently enrolling (NCT05879744)."

Clinical • P1 data • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19

Cullinan Oncology to Present Data Demonstrating Progress Across Its Broad Immunotherapy-Pipeline at SITC 2023 (GlobeNewswire) - "Additional presentations will highlight preclinical data for three other assets: our B7H4X4-1BB bispecific immune activator (CLN-418), our T cell-engaging, CD19-targeted bispecific antibody (CLN-978), and our collagen-binding IL-2/IL-12 fusion protein (CLN-617), as well as a Trials in Progress presentation for CLN-617.”"

Clinical data • Oncology • Solid Tumor

CLN-978, a novel CD19/CD3/HSA T cell engager with extended serum half-life, is effective against lymphoma cells expressing very low levels of CD19 (SITC 2023) - P1 | "Both the CD19/CD3-bispecific T cell-engaging bispecific antibody construct blinatumomab and various autologous CD19-specific CAR-T cell therapies have exhibited robust clinical activity in relapsed/refractory acute lymphocytic leukemia (ALL) and non-Hodgkin lymphoma (NHL). The characteristics of CLN-978 may translate into high response rates and longer response duration in NHL patients expressing normal and very low levels of CD19 on malignant B cells. CLN-978 is currently in Phase 1 clinical development (NCT05879744)."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression. (PubMed, J Immunother Cancer) - "CLN-978 warrants further exploration. An ongoing clinical phase 1 trial is investigating safety, pharmacokinetics, pharmacodynamics, and the initial therapeutic potential of subcutaneously administered CLN-978 in patients with non-Hodgkin's lymphoma."

Journal • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

CLN-978, a novel half-life extended CD19/CD3/HSA-specific T cell-engaging antibody construct with potent activity against B-cell malignancies with low CD19 expression (J Immunother Cancer) - "The half-life extension and high affinity for CD19 led to significant antitumor activity in murine lymphoma models at very low doses of CLN-978. In primates, we observed a long serum half-life, deep and sustained depletion of normal B cells, and remarkable tolerability, in particular, reduced cytokine release when CLN-978 was administered subcutaneously."

Preclinical • Hematological Malignancies • Lymphoma • Oncology

Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-978, a Novel CD19xCD3 T cell Engager, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (GlobeNewswire) - "Cullinan Oncology, Inc...announced that the first patient has been dosed in the Phase 1 clinical trial evaluating CLN-978 for the treatment of relapsed/refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL). The study is an open-label, dose-escalation, dose-expansion, and first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of subcutaneously (SC)-administered CLN-978. The study will enroll adult patients with R/R B-NHL for whom there is no available approved standard therapy."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Cullinan Oncology, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Cullinan Oncology, LLC

New P1 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cullinan Oncology Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "CLN-418....Enrollment is ongoing in a Phase 1 dose escalation study at U.S. and Australian sites in patients with advanced solid tumors with initial clinical data expected in 2024....Consistent with prior guidance, Cullinan received FDA clearance of its Investigational New Drug (IND) application for CLN-978 in January and anticipates initiating a Phase 1 clinical study by the end of 2023....Consistent with prior guidance, Cullinan recently filed the IND application for CLN-617 in February 2023 and intends to initiate a Phase 1 clinical study by the end of 2023, pending IND clearance."

IND • New P1 trial • P1 data • Oncology • Solid Tumor