Merck Completes Acquisition of Investigational Bispecific Antibody Therapy from Curon Biopharmaceutical

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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/