DR-0201

PARIS, France I March 20, 2025 I Sanofi and Dren Bio, Inc., a private clinical-stage biopharmaceutical company, have entered into a definitive agreement under which Sanofi has agreed to acquire DR-0201, a targeted bispecific myeloid cell engager (MCE) that has shown robust B-cell depletion in pre-clinical and early clinical studies. DR-0201 is a potential first-in-class CD20-directed bispecific antibody that targets and engages specific tissue-resident and trafficking myeloid cells to induce deep B-cell depletion via targeted phagocytosis. Recent early clinical study data in autoimmune diseases suggest that deep B-cell depletion might have the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain. Houman Ashrafian Head of Research and Development, Sanofi “Deep B-cell depletion is at the frontier of treating autoimmune diseases and using the myeloid cell engager DR-0201 has the potential to elevate the treatment effect for patients, in particular patients refractory to existing treatments. This is yet another important step in Sanofi’s ambition to bring breakthrough medicines to patients, and further strengthens our robust pipeline focused on the immune system. Through our own research and strategic licensing and acquisitions, we continue to advance our goal of becoming the leader in immunology.” Nenad Tomasevic Co-founder and CEO, Dren Bio “Dren Bio is committed to redefining treatment possibilities in immunology, oncology, and other therapeutic areas with our targeted myeloid engager and phagocytosis platform. It has been a privilege to advance our lead platform program, DR-0201 into clinical development and evaluate its potential to achieve potent B-cell depletion. As a leader in immunology, Sanofi is ideally positioned to unlock the power of deep B-cell depletion and immune reset for autoimmune patients with this novel myeloid cell engager.” About DR-0201 DR-0201 is the first bispecific antibody from Dren Bio’s targeted myeloid engager and phagocytosis platform, which acts by engaging tissue-resident and trafficking myeloid cells to induce deep B-cell depletion. DR-0201 is being evaluated in two ongoing phase 1 studies and has shown deep and robust B-cell depletion in non-clinical and clinical settings. Financial Considerations Under the terms of the merger agreement, Sanofi will acquire DR-0201 through the acquisition of the Dren Bio affiliate Dren-0201 for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievement of certain development and launch milestones. After the acquisition of Dren-0201, Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents. Sanofi’s acquisition of Dren-0201 is subject to closing conditions, including receipt of regulatory approvals. The companies expect the transaction to close during Q2 2025. Sanofi expects to finance the transaction with available cash resources. 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. Dren Bio’s lead product candidate, DR-01, is currently being evaluated in oncology and autoimmune indications. In addition, Dren Bio’s targeted myeloid engager and phagocytosis platform is a bispecific antibody-based technology that induces potent depletion of disease-causing agents by engaging a novel phagocytic receptor that is selectively expressed on myeloid cells and activated only in the presence of the target antigen. For more information about Dren Bio and its current development pipeline, please visit Dren Bio’s website at www.drenbio.com . About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. SOURCE: Sanofi

Sanofi is buying a B cell-depleting antibody developed by Dren Bio as a therapy for cancer and autoimmune diseases. The pharma said on Thursday that it will pay $600 million in cash upfront for the early-stage product, with a potential $1.3 billion to be handed over if the drug hits certain development and launch milestones. The asset in question, called DR-0201, was best known for its potential application in cancer, but Sanofi sees it as a step toward the company’s ambition to become a leader in immunology. The Dren Bio asset is in two Phase 1 trials: one in relapsed/refractory B cell non-Hodgkin lymphoma and another, newly started, in a range of autoimmune conditions. These include systemic and cutaneous lupus erythematosus and progressive systemic sclerosis. Both trials look likely to report data next year. DR-0201 is a CD20-directed bispecific intended to engage specific myeloid cells, prompting them to destroy B cells via phagocytosis. Sanofi said that deep B cell depletion might be able to reset the adaptive immune system, treating refractory B cell-mediated autoimmune diseases such as lupus. The drug has shown “robust” B cell depletion in early clinical studies, Sanofi said, and could work in patients who have not responded to other therapies. Dren has a more advanced asset, the anti-CD94 antibody it calls DR-01, designed to deplete cytotoxic cells including autoreactive CD8 T cells. That’s in a Phase 1/2 study in certain blood cancers, as well as an early-stage trial in alopecia and vitiligo. But DR-0201 is the most advanced product to have emerged from Dren’s myeloid engager and phagocytosis platform. Dren has done deals with pharma companies before, but never an outright sale and never for an asset this advanced. In 2022, it hooked Pfizer as a collaborator, gaining $25 million upfront and potential biobucks worth $1 billion. That deal centered on an unnamed discovery-stage bispecific for solid tumors. And last year it signed up Novartis , again for preclinical assets. That pact covered an undisclosed number of cancer candidates, with the upfront coming in at $150 million, including $25 million in equity, and milestones potentially totaling $2.85 billion. The Sanofi deal announced Thursday is structured as a company acquisition. The French company will buy a Dren Bio affiliate called Dren-0201; if regulators approve, the acquisition should close during the coming quarter. Dren Bio will remain independent.