Canadian immunotherapy company Synthekine has announced a global partnership with Sanofi to develop IL-10 receptor agonists for inflammatory diseases.

Under the deal, Sanofi and Synthekine will work together to research cytokine therapies up to a predefined point in preclinical development. After that, Sanofi will be solely responsible for preclinical, clinical and commercial development of any IL-10 therapeutics.

Sanofi has agreed to give Synthekine a $40m upfront payment, with the potential for additional payments upon reaching preclinical, development, regulatory and commercial milestones, including possible royalties on net sales.

In its programme, the biotech aims to remove the immunostimulatory effects of the drug class, hampering the drug’s toxicity while maintaining efficacy. In its pipeline, the biotech currently has two Phase I candidates and seven candidates in preclinical and investigational new drug application (IND)-enabling stages. These therapies include engineered cytokine partial agonists, surrogate cytokine agonists, and orthogonal cytokine and cell therapy combinations.

Synthekine’s most advanced therapy, STK-012, is a modified IL-2 cytokine that selectively stimulates antigen-activated T cells. In September 2023, Synthekine announced the dosing of the first patient in its Phase Ib study (NCT05098132). The ongoing trial is investigating the therapy for solid tumour types, including renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC).

Several companies have investigated IL-10, an immune regulatory cytokine, as a potential target for immunosuppressive agents. The US Food and Drug Administration (FDA) has not yet approved any IL-10 therapeutics. According to GlobalData, six pharmaceutical companies are investigating IL-10 therapeutics in Phase II studies and three Phase I candidates.

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Xalud Therapeutics is investigating its IL-10 therapy, XT-150 in Phase II studies for neuropathic pain (NCT04466410) and osteoarthritic pain (NCT04124042). Others such as Kolon Life Science and Sunho Biopharmaceutical are also exploring their IL-10 therapeutics in Phase II studies.

GlobalData is the parent company of Pharmaceutical Technology.

In the 29 January press release, Synthekine’s CEO Debanjan Ray said: “This strategic collaboration will advance our broad efforts on IL-10 to capture the full therapeutic potential of this important target and leverages both our cytokine partial agonist platform and our surrogate cytokine agonist platform.”