SunHo Announces First Patient Dosed in Phase 1/2 Clinical Trial of Two First-in-class Immunocytokines: IAP0971 and IAE0972

NANJING,China,July 7,2022 --SunHo BioPharmaceutical Co.,Ltd. ("SunHo"),a clinical-stage leading biopharma in immunocytokines with full-set of capabilities from discovery to commercialization,announced that IAP0971 (PD1-IL15 immunocytokine) and IAE0972 (EGFR-IL10 immunocytokine),two first-in-class immunocytokines developed in-house for the treatment of locally-advanced or metastatic malignant tumors have entered Phase 1/2 clinical trials. The first patient has been dosed respectively in June.

"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 President 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."

About IAP0971

IAP0971 is the world's first PD1-IL15 immunocytokine receiving IND approval from both FDA and NMPA. It was developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

SunHo designed IAP0971 based on the deep understanding of the tumor microenvironment and limitations of current immunotherapy. On the one hand,IL15/IL15Rα complex in IAP0971 specifically binds to the IL2/15Rβ and IL2/15Rγ expressed on T cells and NK cells and promotes the proliferation and activation of T cells and NK cells,without activation of Treg cells or inducing apoptosis of activated T cells which are common side effects of IL2-based therapies. On the other hand,the expression of PD1 on CD8+ T cells in tumor microenvironment is much higher than that in peripheral blood and peripheral lymphoid organs,so that anti-PD1 antibody in IAP0971 can specifically target IL15 into the tumor immune microenvironment,to recruit,activate and reinvigorate immune cells,and achieve a much-enhanced anti-tumor immunity. IAP0971 fuses the anti-PD1 antibody and IL15 cytokine,acts in the same location and on the same cells at the same time showing great cis-synergy,which will further improve the effectiveness and therapeutic window of IAP0971.

The indications of IAP0971 include lung cancer,cervical cancer,head and neck squamous cell carcinoma,liver cancer,lymphoma,and other locally-advanced or metastatic malignant tumors.

About IAE0972

IAE0972 is the world's first EGFR-IL10 immunocytokine receiving IND approval from both FDA and NMPA. It was also developed by SunHo based on their own proprietary and patented AICTM (Armed ImmunoCytokine) platform.

IAE0972 was designed to solve the problems of immune cell exhaustion in current immunotherapy,and to lift the limitations of current EGFR-based monoclonal antibodies. IL10 in IAE0972 is a potent activator of antigen-specific CD8+ T cells in the tumor microenvironment and can restore the tumor-killing activity of tumor-infiltrating lymphocytes by restoring the oxidative phosphorylation metabolism of Terminally Exhausted T cells. Anti-EGFR antibody can specifically enrich IAE0972 in tumor microenvironment,so that IL10 can reinvigorate antigen specific CD8+ T cells and facilitate its proliferation,while preserving the tumor cell proliferation inhibition activities of EGFR antibody. Relying on the synergy of EGFR antibody and IL10 cytokine,IAE0972 can effectively and specifically activate the immune system to kill EGFR-positive tumor cells,solving the drug resistance,high skin toxicities,and other clinical problems of existing drugs.

The indications of IAE0972 include colorectal cancer,squamous non-small cell lung cancer,and other locally advanced or metastatic malignant tumors.

About SunHo

SunHo is a clinical-stage biopharmaceutical company dedicated to the discovery,development,manufacturing,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 Armed ImmunoCytokine Platform (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 the most critical clinical needs,as evidenced by their pipeline of over 20 truly innovative and differentiated products,of which 4 are undergoing clinical trials,4 in IND application and 6 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,and another 2x5000 L lines are coming soon. 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 quality management system of SunHo lives up to the expectations of U.S. Food and Drug Administration (FDA),European Medicines Agency (EMA),and China's National Medicinal Products Administration (NMPA).

For more information,please visit: www.sunho-bio.com and follow SunHo on LinkedIn: www.linkedin.com/company/sunho-china-biopharmaceutical-co-ltd/.

View original content:https://www.prnewswire.com/news-releases/sunho-announces-first-patient-dosed-in-phase-12-clinical-trial-of-two-first-in-class-immunocytokines-iap0971-and-iae0972-301582075.html