Dren Bio Expands Strategic Collaboration with Sanofi to Develop Next-Generation B-Cell Depletion Therapy

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SAN CARLOS, Calif.--(BUSINESS WIRE)--Dec 15, 2025--

Dren Bio, a privately held, clinical-stage biotechnology company developing first-in-class myeloid cell engager therapeutics, announced today that it has entered into a strategic collaboration with Sanofi (NASDAQ: SNY) for the discovery and development of a next-generation B-cell depleting therapy for the treatment of various autoimmune diseases.

The new agreement builds on the existing relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s DR-0201 program for deep B-cell depletion. DR-0201, now known as SAR448501, is currently being evaluated in two ongoing phase 1 studies and has shown robust B-cell depletion, with the potential to induce sustained treatment-free remission in patients with autoimmune diseases.

“Our newly expanded strategic alliance with Dren Bio reflects Sanofi’s deep commitment to developing best-in-class therapies with the potential to achieve remission in patients with immune-mediated diseases,” said Alyssa Johnsen, Global Therapeutic Head, Immunology and Oncology Development at Sanofi. “By combining Dren Bio’s unique scientific approach with Sanofi’s development expertise, we aim to accelerate the development of innovative therapies for patients in need.”

Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added, “Sanofi has been a valued partner in unlocking the full potential of deep B-cell depletion through the acquisition of DR-0201, and we’re thrilled to expand our collaboration by further leveraging the capabilities of our Targeted Myeloid Engager and Phagocytosis platform. The U.S. profit/loss share option allows us to partner with a global commercial leader and represents an important milestone in our growth into a fully integrated biopharmaceutical company.”

Under the terms of the agreement, Dren Bio will receive an upfront payment of $100 million and is eligible to receive up to $1.7 billion in development, regulatory, and commercial milestone payments. The companies will collaborate on discovery and preclinical development activities leveraging Dren Bio’s proprietary platform. Following development candidate selection, Sanofi will assume subsequent responsibility for development, manufacturing, regulatory, and commercialization efforts. Dren Bio has the option to enter into a U.S. profit/loss sharing arrangement with Sanofi. If exercised, Dren Bio will co-fund 40% of ongoing global development costs in exchange for U.S. co-promotion rights and a 50/50 share of U.S. profits and losses. Dren Bio will also remain eligible to receive milestones and tiered royalties on net sales outside the United States.

About Dren Bio

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of novel first-in-class antibody therapeutics for the treatment of cancer, autoimmune, and other serious diseases. Its lead clinical candidate, DR-01, is currently being evaluated in multiple oncology and autoimmune indications. Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform is a multispecific antibody-based technology designed to induce potent depletion of disease-causing agents by engaging a novel phagocytic receptor selectively expressed on myeloid cells. Multispecific antibodies generated from the platform are engineered to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile over other immunomodulatory therapies. Dren Bio’s lead platform candidate, DR-0201, was acquired by Sanofi in May 2025. DR-0201, now known as SAR448501, is currently being evaluated in two ongoing phase 1 studies and has shown robust B-cell depletion, with the potential to induce sustained treatment-free remission in patients with autoimmune diseases. Its second platform candidate, DR-0202, advanced into first-in-human clinical studies in patients with solid tumors in Q2 2025. In addition, Dren Bio has built an extensive preclinical pipeline including additional multispecific antibody programs generated from its platform, targeting indications in oncology, immunology and neurology. For more information, please visit www.drenbio.com.

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PUB: 12/15/2025 08:05 AM/DISC: 12/15/2025 08:06 AM

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