CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.
Merck announced that it has completed its acquisition of CN201, an investigational bispecific antibody, from Curon Biopharmaceutical. CN201 is currently being evaluated for relapsed or refractory non-Hodgkin lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL) in Phase I and Phase Ib/II clinical trials. Early data from the trials suggests that CN201 is well-tolerated and effectively reduces B-cell populations, with potential to provide sustained clinical benefits.1
“By actively depleting B-cells, CN201 offers applications spanning both B-cell malignancies and autoimmune diseases. We look forward to building upon the foundational work started by the Curon team,” said Dean Y. Li, president, Merck Research Laboratories, in a press release.
The Phase I trial consisted of an i3+3 dose-escalation design for adults with CD19+ R/R B-NHL to investigate safety, tolerability, maximum-tolerated dose, and preliminary anti-tumor activity in patients with relapsed or refractory B-cell NHL (R/R B-NHL). During the trial, 58 patients received either fixed or step-up doses of CN201, with no maximum tolerated dose reached. Common adverse events of the trial included decreased white blood cells, neutropenia, and lymphopenia. Cytokine release syndrome was found in 7% of patients, but all cases were classified as mild.
In higher doses, the objective response rate (ORR) was 77%, with a complete remission (CR) rate of 22%. Among patients with indolent B-NHL, the ORR was 91% and the CR rate was 45.5%, including a patient who had previously failed CAR T-cell therapy.2
Under terms of the transaction, Merck is recording a pre-tax charge of approximately $750 million, which is expected to be included in third-quarter non-GAAP results.1 Merck first announced that it had agreed to terms to acquire CN201 from Curon in early August. Moving forward, Curon will be eligible for up to an additional $600 million pending the completion of milestones related to drug development and regulatory approval.3,4
References
1. Merck Completes Acquisition of Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical. Merck. October 1, 2024. Accessed October 1, 2024. https://www.merck.com/news/merck-completes-acquisition-of-investigational-b-cell-depletion-therapy-cn201-from-curon-biopharmaceutical/
2. Phase I study of CN201, a novel CD3xCD19 bispecific antibody, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Journal of Clinical Oncology. May 29, 2024. Accessed October 1, 2024. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.7040
3. Merck to Acquire Investigational Bispecific Antibody for B-Cell Associated Diseases From Curon Biopharmaceutical. PharmExec. August 9, 2024. Accessed October 1, 2024. https://www.pharmexec.com/view/merck-acquire-investigational-bispecific-antibody-b-cell-associated-diseases-curon-biopharmaceutical
4. Merck to Acquire Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical. Merck. August 9, 2024. Accessed October 1, 2024. https://www.merck.com/news/merck-to-acquire-investigational-b-cell-depletion-therapy-cn201-from-curon-biopharmaceutical/
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