Sunho (China) Biopharmaceutical Co., Ltd.

Sanofi has entered a partnership with Synthekine for IL-10 therapeutic development. Credit: Keitma via Shutterstock. 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. 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.”

NANJING, China, July 21, 2023 /PRNewswire/ -- SunHo BioPharmaceutical Co., Ltd. (" SunHo"), a clinical-stage leading biopharmaceutical company in immunocytokines with full-set of capabilities from discovery to commercialization, announced that IBB0979 (B7H3-IL10 immunocytokine), a potential first-in-class immunocytokine developed in-house for the treatment of locally advanced or metastatic solid tumors has entered Phase I/II clinical trials. The first patient has been dosed on Jul 20th, 2023. "We are excited for achieving this important milestone, which also marked the first step to what we hope will ultimately allow us to bring an innovative cancer immunotherapy to patients who otherwise do not respond to or become relapsed/refractory of current therapies", said Dr. Liusong Yin, the Executive Director, Chief Executive Officer and Chief Science Officer of SunHo, "We focus on innovative immunocytokines to build the next leading global biopharma of immunotherapy, and to bring perceivable benefits and affordable medicine to patients worldwide, by innovation and collaboration." IBB0979 is the world's first B7H3-IL10 immunocytokine receiving IND approval from both FDA and NMPA, according to Frost & Sullivan. It was developed by SunHo based on their own proprietary and patented Armed ImmunoCytokine (" AIC™") platform. Other two innovative immunocytokines developed based on their proprietary and patented AIC™ platform, IAP0971(PD1-IL15) and IAE0972(EGFR-IL10) with both U.S. Food and Drug Administration (" FDA") and National Medical Products Administration of People's Republic of China (" NMPA") investigational new drug (" IND") clearance, are expected to initiate the Phase II clinical trials soon. Phase I clinical data showed that IAP0971 and IAE0972 were well tolerated and demonstrated encouraging preliminary anti-tumor activities in patients with locally advanced or metastatic solid tumors. About SunHo SunHo is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative immunocytokines and bifunctional antibody fusion proteins in the fields of cancer immunotherapy and autoimmune diseases. SunHo has developed proprietary and patented AIC™, Armed Innate Effector Multispecific Platform (" AIM™"), and ADCC Enhanced Antibody Platform (" AEA™"). With profound understanding of immunology and tumor microenvironment, SunHo strives to identify and meet unmet clinical needs, as evidenced by their innovative and differentiated products, of which six are undergoing clinical trials and several others are at the pre-clinical stage. SunHo's GMP facilities offer manufacture solutions from drug substance (" DS") to drug product (" DP") production. 1×1000 L and 3×200 L GMP bioreactor lines are available for DS production, 1×5000 L stainless steel bioreactor is under establishment. 1× liquid filling line and 1× lyophilization line also cater to the need of aseptic processing of biologics (liquid and lyophilized preparations) for clinical trials and commercialization. The manufacturing facilities of SunHo lives up to the expectations of FDA, European Medicines Agency (" EMA"), and NMPA. For more information, please visit website of SunHo at and follow SunHo on LinkedIn at . SOURCE SUNHO (China) BioPharmaceutical Co., Ltd.