Merck to Gain Investigational Bispecific Antibody in $1.3 Billion Curon Biopharmaceutical Deal

Editor's note: this story was originally published on BioPharmInternational.com.

Merck, known as MSD outside of the United States and Canada, entered into a definitive agreement earlier this month with Curon Biopharmaceutical (Curon), a privately held biotechnology companyunder. With the agreement, Merck, through one of its subsidiaries, will acquire full global rights to CN201, Curon's novel investigational clinical-stage bispecific antibody for treating B-cell associated diseases.

The deal is worth potentially up to $1.3 billion, comprising an upfront payment by Merck of $700 million in cash and up to $600 million in milestone payments for which Curon is eligible, contingent upon the development and regulatory approval of CN201, according to an Aug. 9, 2024 company press release. The transaction is expected to close in the third quarter of 2024, subject to customary closing conditions.

“We continue to identify opportunities to expand and diversify our pipeline,” said Dean Y. Li, MD, PhD, president, Merck Research Laboratories, in the press release. “Early clinical data have provided robust evidence for the potential of CN201 to target and deplete circulating and tissue B cells with the potential to treat a range of malignant and autoimmune diseases.”

CN201, a novel CD3xCD19-targeting T-cell-engager bispecific antibody, is designed to target B cells for elimination by T cells. It is currently being evaluated in a Phase I clinical trial for treating relapsed or refractory non-Hodgkin’s lymphoma and in a Phase Ib/II clinical trial for treating relapsed or refractory acute lymphocytic leukemia. According to preliminary data, CN201 demonstrated activity in patients with relapsed or refractory B-cell hematologic malignancies and has been shown to be well tolerated. It has demonstrated the potential to induce significant and sustained reductions in B-cell populations. Merck aims to evaluate CN201 as a treatment for B-cell malignancies and investigate its potential to provide treatment for autoimmune diseases.

“This agreement reflects the drive and dedication of the Curon team,” said Zhihong Chen, president and CEO, Curon, in the press release. “As a pioneer in immuno-oncology, Merck is well positioned to build upon the work done to-date and investigate the wide-ranging, first-in-class potential of CN201.”

Also in August, Merck expanded its existing co-development and co-commercialization agreement with Daiichi Sankyo for three investigational derivatives of exatecan (DXd) antibody-drug conjugates (ADCs). Under the expanded agreement, Merck’s investigational delta-like ligand 3 (DLL3) targeting T-cell engager, MK-6070, was added, and the companies will jointly develop and commercialized the drug candidate worldwide, except in Japan where Merck will retain exclusive rights, according to an Aug. 6, 2024 company press release. Merck will have sole responsibility for manufacturing and supply for MK-6070.

Under this expanded agreement, Merck gets an upfront payment of $170 million in cash; it has also satisfied a contingent quid obligation from the original collaboration agreement with Daiichi Sankyo. Meanwhile, both companies will share R&D and commercialization expenses and profits worldwide, excluding Japan. For Japan, while Merck retains exclusive rights, Daiichi Sankyo will receive sales-based royalties. Furthermore, R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared between the companies according to their original agreement for ifinatamab deruxtecan.

MK-6070 is currently being evaluated in a Phase I/II clinical trial as a monotherapy in certain patients with advanced cancers associated with the expression of DLL3 and in combination therapy with atezolizumab for treating certain patients with small cell lung cancer (SCLC). In March 2022, FDA granted MK-6070 orphan drug designation for treating SCLC.

Reference

1. Merck. Daiichi Sankyo and Merck Enter into Global Development and Commercialization Agreement for MK-6070. Press Release, Aug. 6, 2024.

Source: Merck, known as MSD outside of the United States and Canada