Shenzhen Second People's Hospital

HONG KONG, Nov. 22, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer. The sNDA for this new indication is supported by the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, parallel-controlled Phase III clinical trial. The study demonstrated positive outcomes in both progression-free survival (PFS) and overall survival (OS). These encouraging clinical results were featured as a "Late Breaking Abstract (LBA)" at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. Clinical data highlights: Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001); Penpulimab combined with anlotinib regimen reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013). The combination of penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. This makes the combination a promising first-line treatment option for advanced HCC. The ALTN-AK105-III-02 study marks the second global Phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multi-targeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC. These encouraging findings pave the way for this combination therapy to become a superior treatment option for patients with advanced hepatocellular carcinoma. About Penpulimab Penpulimab is a differentiated PD-1 monoclonal antibody with an IgG1 subtype and modified Fc region, enhancing immunotherapy efficacy while minimizing adverse reactions. Developed by Akeso Biopharma, its commercialization is managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharm. Penpulimab has been approved for the following indications: First-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. Relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic chemotherapy. Recurrent/metastatic nasopharyngeal carcinoma (NPC) who have failed to respond to two or more prior lines of systemic therapy. Penpulimab in combination therapy for the first-line treatment of metastatic NPC, has had its marketing application accepted by the NMPA and the FDA. Additionally, the marketing application for its monotherapy use in third-line or further treatment of metastatic nasopharyngeal carcinoma has also been accepted by the FDA. Ongoing late-stage clinical trials of penpulimab are progressing for liver cancer, gastric cancer, and other indications. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique 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 core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter) SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Glioblastoma multiforme (GBM) is an aggressive brain cancer with a poor prognosis and few treatment options. New and effective approaches for GBM treatment are therefore urgently needed. Based on observation of elevated lactate in resected GBM, researchers from the Institute of Process Engineering (IPE) of the Chinese Academy of Sciences and Shenzhen Second People's Hospital have developed a biomimetic formulation using targeted delivery agents for lactate metabolism-based synergistic therapy against GBM. The study was published in Nature Communications on July 21. Targeting lactate metabolism is an attractive tumor therapeutic strategy. However, there are no reports that directly harness lactate metabolism for GBM treatments. One limitation is the existence of the blood-brain barrier, which prevents most drug molecules (including those interfering with lactate metabolism) from reaching the brain. Moreover, considering the complexity and infiltrating characteristics of GBM, lactate metabolic monotherapy is very unlikely to effectively eliminate GBM cells. Therefore, it is vital to develop synergistic strategies to enhance the therapeutic efficiency of lactate metabolic therapy. In this study, the researchers collected glioma samples from a large cohort of patients and quantified the lactate metabolic indicators LDHA and MCT4 and a representative proliferation marker Ki67. "We observed a positive correlation between lactate metabolic indicators and the extent of glioma proliferation," said Prof. LI Weiping from Shenzhen Second People's Hospital. Thus, an efficient metabolism-based synergistic therapy was proposed that would directly harness the elevated lactate in GBM. The researchers fabricated self-assembly nanoparticles (NPs) composed of hemoglobin (Hb), lactate oxidase (LOX), bis[2,4,5-trichloro-6-(pentyloxycarbonyl)phenyl] oxalate (CPPO), and chlorin e6 (Ce6) using a one-pot approach. They subsequently encapsulated these self-assembled NPs with membrane materials prepared from U251 glioma cells to generate the biomimetic M@HLPC system. This design concept was able to achieve targeted delivery for combination therapy. "After intravenous injection, the M@HLPC could cross the blood brain barrier via transcytosis sourced from integrin and vascular cell-adhesion-protein-mediated recognition, and then accumulated in GBM through homotypic recognition based on cell-recognition-function-associated proteins," said Prof. WEI Wei from IPE. In tumors, LOX in the NPs converted lactate into pyruvic acid and hydrogen peroxide (H2O2). The pyruvic acid inhibited cancer cell growth by blocking histone expression and inducing cell-cycle arrest. In parallel, the H2O2 acted as a local fuel to react with the delivered CPPO to release energy, which could then be used by the co-delivered photosensitizer Ce6 for the generation of cytotoxic singlet oxygen to kill glioma cells. Potent therapeutic efficacy was confirmed in both cell-line-derived xenograft and patient-derived xenograft (PDX) tumor models. "Considering the safety of the formulation and the potent therapeutic effects against the matched PDX model, our personalized biomimetic formulation has the potential to translate to clinical application," said Prof. MA Guanghui from IPE. A peer reviewer from Nature Communications said, "The idea of this work is interesting." Another reviewer emphasized that "a multi-targeting, personalized, smart nanoplatform to tackle glioblastoma multiforme is presented. Rationale is well explained, I indeed appreciate the multi-strategies approach and the biomolecular characterization." Lu G, Wang X, Li F, Wang S, Zhao J, Wang J, Liu J, Lyu C, Ye P, Tan H, Li W, Ma G, Wei W. Engineered biomimetic nanoparticles achieve targeted delivery and efficient metabolism-based synergistic therapy against glioblastoma. Nat Commun. 2022 Jul 21;13(1):4214. doi: 10.1038/s41467-022-31799-y