Dupilumab

iStock, Panama7 The deal is the latest in a series of Sanofi investments in its immunology portfolio. According to Sanfoi, DR-0201 can achieve deep B cell depletion, giving it the potential to reset the immune system. In the latest investment in the immunology space, Sanofi has agreed to a $600 million upfront payment to buy Dren Bio’s investigational bispecific antibody DR-0201 in a deal announced Thursday. The asset is a targeted cell engager that binds to the CD20 protein on B cells, tagging them for destruction. In early clinical studies, DR-0201 has demonstrated the ability to strongly deplete B cells, an effect that according to Sanofi’s release on Thursday gives it the “potential to reset the adaptive immune system.” Under Thursday’s agreement, Sanofi has also promised to hand over up to $1.3 billion in certain development and launch milestone payments. The companies expect to close the transaction in the second quarter of 2025, contingent on regulatory approvals and other customary conditions. It remains unclear what the arrangement for royalties will be. Houman Ashrafian, head of research and development at Sanofi, said in a statement that this approach of inducing deep B cell depletion “is at the forefront of treating autoimmune diseases” and has “the potential to elevate the treatment effect for patients,” especially those who show poor or suboptimal response to existing therapies. DR-0201 is currently in a Phase I trial for B cell non-Hodgkin lymphoma, as well as a Phase I basket trial for patients with autoimmune rheumatic diseases. With the DR-0201 buy, Sanofi moves closer to its ambition of becoming an “the leading immunology company,” as Ashrafian said in a May 2024 statement . The pharma already has an imposing presence in this space with its Regeneron-partnered blockbuster drug Dupixent, originally approved in 2017 for atopic dermatitis and racking up additional immune-related indications, most recently for chronic obstructive pulmonary disease . Dupixent is the first biologic to be approved for this indication. To add to its success with Dupixent, Sanofi has made a number of recent deals to bolster its immunology portfolio. In June 2024, the company linked up with Belharra Therapeutics to develop small-molecule drug candidates against undisclosed immunology target. The pharma paid $40 million upfront and pledged nearly $700 million in additional payments under this contract. In October 2023, Sanofi inked a potential $1.5 billion partnership with Teva Pharmaceuticals to develop TEV’574, an investigational anti-TL1A agent being studied for ulcerative colitis and Crohn’s disease. A few months earlier, Sanofi teamed up with Recludix Pharma, putting more than $1.3 billion on the line to advance oral STAT6 inhibitors for immunology and inflammatory indications. Clarification (March 20): This story has been updated from its original version to clarify that $1.9 billion is the total potential value of the deal and that DR-0201 is being studied in a Phase I trial for autoimmune disease. BioSpace regrets any confusion.

Sanofi is increasing focus on innovative medicines while moving away from consumer health. Image credit: Shutterstock/Below the Sky. Sanofi is continuing its immunology pipeline push with an agreement to acquire Dren Bio’s bispecific antibody DR-0201 in a deal whose value could rise to $1.9bn. The deal for the clinical asset will be made through Sanofi’s acquisition of Dren Bio affiliate Dren-0201. The French company will pay $600m upfront, with milestone payments of $1.3bn. After Dren-0201 gets under Sanofi’s control, Dren Bio will continue to advance the rest of its pipeline independently. The deal is expected to close during Q2 2025. Investor reaction to the deal was tepid, with shares in the Paris-listed Sanofi opening with a 0.3% deficit. Global stock markets are still recovering from the effects of US government tariffs, meaning current links between company activities and share prices are tenuous. Sanofi will fund the transaction with cash resources – an indication the company is in a financially strong position considering it is also undertaking a $5.1bn share buyback initiative this year. Sanofi has been spending big money recently to bolster its immunology presence. This includes a collaboration with Teva Pharmaceuticals, which included a $500m upfront payment in December 2023, for the co-development of chronic inflammatory disease treatment TEV-‘574. The company also agreed to a licensing deal worth up to $700m in June 2024 to use an immunology-centric small molecule drug discovery platform developed by Belharra Therapeutics. Dren Bio’s DR-0201 is a bispecific myeloid cell engager (MCE), which is being evaluated in a Phase I trial (NCT06392477) for the treatment of relapsed or refractory B cell non-Hodgkin lymphoma. The drug works by trafficking myeloid cells to induce deep B cell depletion. While DR-0201 clinical data has not been disclosed, Sanofi said it has “shown deep and robust B cell depletion in non-clinical and clinical settings.” Dren Bio’s lead candidate is DR-01, an antibody designed to deplete T cells, which are known to play a role in haematological and autoimmune diseases. The therapy, which is currently being investigated in leukaemia and cytotoxic lymphoma patients in a Phase II trial (NCT05475925), produced positive Phase I data . For Sanofi, the acquisition of DR-0201 represents the continuation of a push into the immunology space. Historically known for its plethora of vaccines, the company has seen financial success from anti-inflammatory blockbuster Dupixent (dupilumab). The drug, which is co-marketed with Regeneron, generated sales of €3.5bn ($3.8bn) in 2025. Commenting on the Dren Bio deal, Sanofi’s head of research and development, Houman Ashrafian, said: “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.” Sanofi is in the process of honing its focus on innovative medicines and vaccines while transitioning away from consumer health offerings. The company is close to selling its $17bn consumer health business Opella.