HONG KONG, Oct. 30, 2023 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase Ib clinical trial for PD-1/VEGF bispecific antibody ( ivonecimab AK112/SMT112 ) as first- or second-line therapy for advanced or metastatic immunotherapy naïve non-small-cell lung cancer (NSCLC) were published in the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC). The principal investigator of this study is Prof. Caicun Zhou, MD, PhD, from Shanghai Pulmonary Hospital, affiliated with Tongji University.

Previously, the clinical results of ivonescimab in combination with chemotherapy for NSCLC were published in the eClinical Medicine (part of The Lancet). The monotherapy results published in JTO represents another significant recognition of the clinical value of ivonescimab.

The phase Ib study, published in JTO, aims to determine the optimal dose, safety, and efficacy of ivonescimab monotherapy as a first- or second-line treatment for advanced NSCLC patients. Early data on ivonescimab in NSCLC was also presented at the 2022 American Society of Clinical Oncology (ASCO) meeting.

From the data published in JTO, patients with advanced or metastatic NSCLC can benefit from ivonescimab monotherapy regardless of treatment dosage, prior treatment history, and PD-L1 expression. This data was based on a median follow-up of 10.4 months (as of October 5, 2022). Furthermore, updated data from the study (with a median follow-up of 19.3 months) as of June 30, 2023 demonstrates the increased safety and survival benefits of ivonescimab monotherapy.

Currently, following an acceptance of the marketing application with priority review of ivonescimab by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), four registrational phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug, and two international multicenter clinical trials.

About Ivonescimab (PD-1/VEGF bispecific antibody)

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics ("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso' R&D code at China and Australia, and as SMT112 for Summit's license territories.

About Akeso, Inc.

Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception , we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.

Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, NDAs for 4 drugs and 6 indications accepted, and 13 ongoing Phase III studies. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug to the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies.

In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA and granted Priority Review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.

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