MK-1045 / Merck (MSD), Curon Biopharma - LARVOL DELTA

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory follicular lymphoma (ASH 2025) - P1 | "MK-1045 (CN201) is a humanized bispecific IgG4 CD19xCD3 T-cellengager that has shown encouraging safety, tolerability, and preliminary efficacy in participants (pts) withrelapsed or refractory (R/R) B-cell non-Hodgkin lymphomas (Xie et al... With 17 months of additional follow-up since the prior report, the results of this analysis haveshown that MK-1045 led to high CR rates at target doses ≥5 mg and a manageable safety profile with lowrates of CRS and no cases of ICANS in pts with R/R FL. These findings are consistent with those of theearlier analysis of the broader cohort of pts with B-cell non-Hodgkin lymphoma."

P1 data • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Interstitial Lung Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Pulmonary Disease • Respiratory Diseases

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory diffuse large B-cell lymphoma (ASH 2025) - P1 | "MK-1045 (CN201) is a humanized bispecific IgG4CD19xCD3 T-cell engager that has demonstrated encouraging safety, tolerability, and preliminary efficacyin participants (pts) with R/R B-cell non-Hodgkin lymphomas (Xie et al... With 17 months of additional follow-up since the prior report, the results of this analysis havedemonstrated that MK-1045 led to encouraging efficacy at target doses ≥60 mg with a manageable safetyprofile with low rates of CRS and no cases of ICANS in pts with R/R DLBCL. These findings are consistentwith those of the earlier analysis of the broader cohort of pts with B-cell non-Hodgkin lymphoma."

IO biomarker • P1 data • B Cell Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Insomnia • Lymphoma • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • Sleep Disorder • CD19

Updated results from the Phase 1b/2 study of MK-1045, a novel CD19xCD3 T-cell engager, in adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ASH 2025) - P1/2 | "Introduction: MK-1045 (CN201) is a humanized bispecific IgG4 CD19xCD3 T-cell engager that has shownencouraging safety, tolerability, and preliminary efficacy in participants with relapsed or refractory (R/R)B-cell acute lymphoblastic leukemia (B-ALL) (Wang et al...Among participants withprior exposure to blinatumomab or CAR T-cell therapy who had received a target dose ≥60 mg, 5 of 5participants achieved CR/CRi/CRh and 4 achieved MRD negativity... The safety profile of MK-1045 in adult participants with R/R B-ALL has been generallymanageable with dose modifications and standard medical care. MK-1045 has shown encouraging singleagent antitumor activity in adult participants with R/R B-ALL, achieving a CR/CRi/CRh rate of 92% at the2/20/90 mg dose level."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia

Novel Treatment Displays Tolerability in Relapsed/Refractory B-Cell ALL (Cancer Network) - "Treatment with MK-1045 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) displayed a generally manageable safety profile with dose modifications and standard medical care, according to findings from the phase 1b/2 trial (NCT05579132) presented in an oral presentation given at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition...Safety data revealed that among 75 patients treated across 9 dose levels on the trial, all had experienced at least 1 treatment-emergent adverse effect (TEAE), 89% of which were grade 3 to 5 in severity...Regarding efficacy data, at the 60 mg and 90 mg (n = 12, 12) dose levels, 75% and 92% experienced a CR as best overall response, with 58% and 75% of patients experiencing a CR with complete hematologic recovery, and 8% of each dose level experiencing a CRi, and 8% of each experiencing a CRh."

P1/2 data • B Acute Lymphoblastic Leukemia

Merck…announced that new data across multiple hematologic malignancies will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla. from Dec. 6-9. (Merck (MSD) Press Release) - "Data presentations will feature Merck’s pipeline candidates, including: MK-1045, an investigational CD19xCD3 T-cell engager; bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; and nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. Additionally, Merck will present new and updated results highlighting zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1)."

Clinical data • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Essential Thrombocythemia • Follicular Lymphoma • Marginal Zone Lymphoma • Polycythemia Vera

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101) (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial completion date: Sep 2027 ➔ Mar 2029

Trial completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101) (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial completion date: Dec 2025 ➔ Sep 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CN201-103: A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002) (clinicaltrials.gov) - P1/2 | N=203 | Recruiting | Sponsor: MSD R&D (China) Co., Ltd. | Trial completion date: Jul 2025 ➔ Jan 2027 | Trial primary completion date: May 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Merck Completes Acquisition of Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical (Businesswire) - "Merck...announced the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases."

Commercial • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

Merck to Acquire Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical (Merck (MSD) Press Release) - "Merck...and Curon Biopharmaceutical...announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases....Under the terms of the agreement, Merck through a subsidiary will acquire full global rights to CN201 for an upfront payment of $700 million in cash. Curon is also eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201....The transaction is expected to close in the third quarter of 2024 and be accounted for as an asset acquisition."

Commercial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase I study of CN201, a novel CD3xCD19 bispecific antibody, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. (ASCO 2024) - P1 | "CN201 has a well tolerable safety profile and promising anti-tumor activity in patients with R/R B-NHL."

Clinical • P1 data • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. (ASCO 2024) - P1/2 | "Preliminary data show CN201 has a well tolerable safety profile and promising activity in adult patients with relapsed or refractory ALL."

Clinical • P1 data • Acute Lymphocytic Leukemia • Anemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Leukopenia • Neutropenia • Oncology • Thrombocytopenia

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN201 (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Curon Biopharmaceutical (Shanghai) Co.,Ltd

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

A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=203 | Recruiting | Sponsor: Curon Biopharmaceutical (Shanghai) Co.,Ltd | N=113 ➔ 203 | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Feb 2024 ➔ May 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

An Open-label, Multi-center Phase Ib/II Study of CN201 in Adult Subjects With Precursor B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=113 | Recruiting | Sponsor: Curon Biopharmaceutical (Shanghai) Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

An Open-label, Multi-center Phase Ib/II Study of CN201 in Adult Subjects With Precursor B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=113 | Not yet recruiting | Sponsor: Curon Biopharmaceutical (Shanghai) Co.,Ltd

New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology