Ahead of JP Morgan 2026, pharmaceutical giant Sanofi has inked another deal with Helixon Therapeutics-affiliated startup Earendil Labs, which will see the pair collaborate on bispecific antibodies for autoimmune and inflammatory conditions.
The agreement, which could be worth up to $2.56 bn, will see Sanofi utilise Earendil’s artificial intelligence (AI)-powered drug discovery platform to assist in the development of multiple autoimmune and inflammatory disease assets.
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Earendil’s platform incorporates predictive protein modelling with high-throughput experimental validation, which the biotech’s CEO, Jian Peng, says can assist in identifying new bispecifics and optimising their efficacy.
Through this pact, Sanofi will hand over $160m in upfront and near-term payments, while agreeing to a potential further $2.4bn in development and commercial milestone payments in exchange for the global rights to any assets created from the collaboration.
While Sanofi will retain the full rights to any therapies that reach the market, Earendil will be eligible to receive tiered royalties on net product sales, which will likely sit in the low double-digit range.
Sanofi’s latest deal with Earendil follows the company’s agreement to buy the rights to two of its bispecific autoimmune assets – HXN-1002 for ulcerative colitis (UC) and Crohn’s disease and HXN-1003 for colitis and skin inflammation – for up to $1.8bn back in April 2025.
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By GlobalDataThis deal is the newest of a range of agreements that Sanofi has signed in recent months, with the company having handed over $1.7bn and $1.04bn in two separate licensing deals with Dren Bio and ADEL in December 2025.
Sanofi also bolstered its vaccine pipeline back in December through a $2.2bn acquisition of the adults-only hepatitis B jab manufacturer, Dynavax. This acquisition comes despite the US Center for Disease Control’s (CDC) recent decision to revoke the long-standing hepatitis B jab recommendation for infants, which was met with significant kickback from medical organisations.
Bispecifics to break into the autoimmune sector
As precision medicine continues to grow, companies are increasingly looking to develop therapies that can offer targeted efficacy.
As a result, bispecific antibodies are gaining significant traction, as this modality offers enhanced precision over its monoclonal counterpart, which has been widely successful across the autoimmune sector.
Roche is hoping that its oncology asset, Lunsumio (mosunetuzumab), will show benefit in systemic lupus erythematosus (SLE). The therapy is currently in a Phase II trial, which is set for completion near the end of 2028.
Meanwhile, AbbVie is exploring the potential of its bispecific, lutikizimab, in a Phase III trial in hidradenitis suppurativa (HS) after the drug displayed promise in a mid-stage study. The drug is also in mid-stage trials for atopic dermatitis and UC.
Hurdles to bispecific success in the autoimmune segment
According to Vasilis Roumpelakis, associate director of Competitive Intelligence and Competitive Strategy at GlobalData, bispecifics could hold significant potential in the autoimmune market, but the evidence “remains early stage and selective”.
“Their mechanistic case is compelling, as single-target therapies often hit a therapeutic ceiling, while bispecific antibodies may address this by engaging two distinct targets with a single molecule, potentially overcoming resistance and improving efficacy via enhanced tissue penetration and localised activity,” Roumpelakis said.
Despite therapeutic promise, Roumpelakis noted that drugmakers must overcome substantial chemistry, manufacturing and control (CMC), regulatory and commercial hurdles that mAbs do not face.
Heavy/light chain mispairing, as well as purification complexity, can pose significant manufacturing challenges, while their increased risk of immunogenicity is also notable, Roumpelakis added.
“In contrast with oncology, the absence of validated predictive biomarkers represents a critical limitation constraining optimal deployment of bispecific antibodies in autoimmune diseases,” Roumpelakis added.
While he believes that the widespread adoption of bispecifics in the autoimmune space is plausible, it will remain “contingent on successful proof-of-concept and Phase III studies, as well as the resolution of manufacturing and regulatory barriers”.
GlobalData is the parent company of Pharmaceutical Technology.
