Belharra Therapeutics, Inc.

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.

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.

Agomab’s lead candidate is being investigated as a treatment for patients with fibrostenosing Crohn’s disease (FSCD). Credit: Hananeko_Studio via Shutterstock. Agomab Therapeutics has secured $89m in Series D funding to support clinical trials of its fibrotic disease treatments, with some help from Sanofi . Belgium-based Agomab announced that Sanofi and Invus have joined as new investors in its latest funding round, following on from a $100m Series C round in October 2023, and a $114m Series B where Pfizer led an extension round. The funds will be used to advance the development of Agomab’s lead candidate AGMB-129, a treatment for patients with fibrostenosing Crohn’s disease (FSCD). The oral small molecule inhibitor of ALK5 (TGFβ1R) is currently being investigated in the Phase IIa STENOVA trial (NCT05843578). The company expects to share interim results from the 90-patient trial in early 2025. Positive data from the Phase I trial (NCT04933565) of AGMB-129 was reported in February 2023, where the candidate demonstrated high local exposure in the ileum, with no drug-related safety signals or dose-limiting toxicities. Patients with FSCD have strictures in the intestines caused by inflammation and scarring, for which there is no cure. The company also has an inhaled treatment for idiopathic pulmonary fibrosis (IPF), named AGMB-447, and a liver cirrhosis candidate AGMB-101. AGMB-447 is being investigated in a Phase I trial (NCT06181370) and Agomab plans to start clinical development of AGMB-101, which is “in the final stages of IND-enabling studies”. See Also: Dyno and Roche collaborate on neurological gene therapies Takeda and BMC partner to decarbonise US healthcare sector Sanofi continues to assert itself in the immunology space, signing deals with parties such as Recludix, Teva Pharmaceutical and IGM Biosciences . The company expanded its immunology pipeline further in June 2024, entering a $700m strategic partnership with Belharra Therapeutics to spur the development of small molecule therapies for immunological diseases. Sanofi and Regeneron’s immune-targeting biologic Dupixent (dupilumab) has been picking up label expansions since its 2017 US Food and Drug Administration (FDA) approval for atopic dermatitis. The drug earned $11.6bn last year, as per Regeneron’s financials, and is set to generate $23.6bn in 2030, according to GlobalData consensus forecasts. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the funding, Agomab’s CEO Tim Knotnerus said: “We are thrilled to have Sanofi and Invus joining our investor syndicate. Their investment as well as the continued support from our existing shareholders is another validation of the trailblazing work our team is conducting in the fields of fibrostenosing Crohn’s disease and idiopathic pulmonary fibrosis.”