SunHo Announces First Patient Dosed in Phase I/II Clinical Trial of a Potential First-in-class Immunocytokine IBB0979

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 20^th, 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 www.sunho-bio.com.cn and follow SunHo on LinkedIn at www.linkedin.com/company/sunho-china-biopharmaceutical-co-ltd/.

SOURCE SUNHO (China) BioPharmaceutical Co., Ltd.

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