Merck & Co. has entered into an agreement with Curon Biopharmaceutical to acquire global rights to Curon's CN201, a CD3xCD19 bispecific T-cell engager, for up to $1.3 billion. This strategic move positions Merck against competitors like Amgen and AstraZeneca in the rapidly evolving oncology sector.
CN201: A Promising Bispecific T-Cell Engager
CN201 is designed to target B cells for depletion by T cells. B cells, while crucial for antibody production, can also contribute to the development of cancers and autoimmune diseases. The bispecific T-cell engager is currently undergoing Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia. Preliminary data from these trials have been encouraging, demonstrating complete responses in some patients.
The deal includes a $700 million upfront payment to Curon, with the potential for an additional $600 million in regulatory and sales milestone payments. This substantial upfront payment, compared to recent averages for Phase 2 assets, underscores Merck's confidence in CN201's clinical potential and the growing enthusiasm for bispecific T-cell engagers as a therapeutic modality.
Bispecifics vs. Cell Therapies
The increasing interest in bispecific antibodies is partly driven by their convenience in administration and manufacturing efficiency compared to CD19-targeting cell therapies. Amgen's Blincyto (blinatumomab), a CD3xCD19 BiTE approved in 2014 for acute lymphoblastic leukemia, paved the way for this class of drugs. AstraZeneca also entered the field with its acquisition of TeneoTwo, bringing the CD3xCD19 BiTE candidate AZD0486 into its portfolio. AZD0486 is currently in Phase 2 trials for non-Hodgkin lymphoma, with plans for a Phase 3 trial in follicular lymphoma.
Expanding Beyond Oncology: Autoimmune Potential
Emerging research suggests that B-cell depletion therapies may also be effective in treating autoimmune conditions. Encouraging data have been published on CD19-targeting CAR-T candidates in lupus, and a study using Blincyto in patients with multiple drug-resistant rheumatoid arthritis reported complete responses. This has led to a trend where companies initially focused on CD19-targeting therapies for cancer are now exploring their potential in the autoimmune space. For example, Cullinan Oncology recently shifted its focus from oncology to systemic lupus erythematosus for its CD19xCD3 T-cell engager.
Financial Trends in Biopharma Partnering
A recent J.P. Morgan report highlighted a trend of decreasing upfront payments in biopharma deals. Upfront payments, which accounted for 12-13% of the overall deal value in 2019-2020, have fallen to around 6% in the first half of 2024. This indicates that deals are becoming more backloaded, with a greater proportion of the potential value tied to milestone payments. The report suggests this trend reflects risk-averse attitudes from big pharma, a challenging financing market for biotech companies, and increased competition due to the availability of innovative assets from Chinese biotechs.