Lenvatinib mesylate

SAN FRANCISCO and SUZHOU, China, June 3, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announced the third oral presentation of clinical data for IBI363 (first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) in advanced non-small cell lung cancer at the 2025 American Society of Clinical Oncology (ASCO), following IBI363's other two oral presentations in colorectal cancer and melanoma. A manageable safety profile, encouraging efficacy, and trends in long-term survival benefits have been observed in both immunotherapy-resistant squamous non-small cell lung cancer (NSCLC) and wild-type lung adenocarcinoma. It is worth mentioning that Innovent's pipeline has a total of 8 oral presentations at this ASCO conference, representing approximately 2% of the conference's total oral presentations. Innovent Biologics is conducting clinical studies in China, the United States, and Australia to explore the efficacy and safety of IBI363 for multiple tumor indications, including immune resistance, cold tumors, and front-line treatments. At this year's ASCO meeting, three oral presentations of IBI363 reported encouraging Phase 1/2 clinical data in the first three indications explored—NSCLC, CRC, and melanoma—focusing on IO-resistant and cold tumors. The data comprehensively demonstrated the breakthrough clinical outcomes of IBI363 across these indications, from robust tumor response to long-term survival benefits. These findings provide strong support of the drug's novel mechanism of action translating effectively into clinical outcomes, and imply its potential for broader clinical development, offering new hope in areas of immunotherapy where treatment options remain limited. PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients with immunotherapy resistant advanced non-small cell lung cancer: results from a Phase 1 study Updated data on IBI363 monotherapy in patients with advanced NSCLC were reported (ClinicalTrials.gov, NCT05460767). As of the data cutoff date, April 7, 2025, a total of 136 patients with NSCLC had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W), including 67 with squamous cell carcinoma and 58 with EGFR wild-type adenocarcinoma. IBI363 showed breakthrough therapeutic potential from tumor response to long-term survival benefit in immuno-resistant squamous NSCLC All 67 squamous NSCLC patients were EGFR wild type. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportion of ≥2 lines of previous systemic therapy was 64.3% (18/28) vs 67.7% (21/31), the proportion of previous anti-PD-1/PD-L1 therapy was 100% (28/28) vs 96.8% (30/31) and the proportion of PD-L1 TPS<1% was 35.7% (10/28) vs 41.9% (13/31). In the 1/1.5 mg/kg dose group, promising ORR/DCR/PFS/OS were observed. Median OS achieved 15.3 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 1/1.5 mg/kg dose group, the 3 mg/kg Q3W dose group observed more prominent confirmed ORR (36.7%), DCR (90.0%), PFS (median PFS 9.3 months) and OS trends (median OS not reached, 12-month OS rate 70.9%) (see the table below). Among the patients with PD-L1 TPS<1%, IBI363 demonstrated outstanding efficacy signals: in the 1/1.5 mg/kg group (N=10), the confirmed ORR was 30.0% and the DCR was 90.0%, while that of the 3 mg/kg group (N=13) were 46.2% and 92.3%, suggesting the potential advantage of IBI363 in the population with low expression of PD-L1. IBI363 showed potential for long-term survival benefits in immuno-resistant wild-type lung adenocarcinoma, especially in patients with smoking history Among the 58 patients with EGFR wild-type lung adenocarcinoma, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, 25 patients received IBI363 at 3 mg/kg Q3W. In the two groups of patients, the proportions of ≥2 lines of previous systemic therapy were 80.0% (24/30) vs 64.0% (16/25), the proportions of previous anti-PD-1/PD-L1 therapy were both 100%, the proportions of PD-L1 TPS<1% were 26.7% (8/30) vs 40.0% (10/25) and the proportions of smoking history were 56.7% (17/30) vs 60.0% (15/25). In the 1/1.5 mg/kg dose group, median OS achieved 17.5 months, suggesting the potential long-term survival benefit of IBI363 as a PD-1/IL-2α-bias bispecific immunotherapy. Compared with the 0.6/1/1.5 mg/kg dose group, the 3 mg/kg dose group observed higher confirmed ORR (24.0%), DCR (76.0%), PFS (median PFS 5.6 months) and OS trends (median OS not reached, 12-month OS rate 71.6%) (see the table below). Higher ORR and PFS were observed in lung adenocarcinoma patients with a history of smoking. Among them, the confirmed ORR in the 0.6/1/1.5 mg/kg group (N=17) was 23.5%, and the confirmed ORR in the 3 mg/kg group (N=15) was 33.3%. In all dose groups (N=32), the median PFS of smokers was longer than non-smokers: 5.3 (2.0, 7.0) vs 3.0 (1.6, 5.1) months. In terms of long-term survival benefits, after follow-ups of 12.0 and 13.7 months, the median OS for non-smokers was 13.6 months, whereas the median OS for smokers was not yet reached, with only 9 (28.1%) events occurring. IBI363 had a manageable safety profile in advanced NSCLC Among the 57 patients with NSCLC in the 3 mg/kg dose group, the most common treatment related adverse events (TRAEs) of grade 3 or above were arthralgia and rash. 7.0% of patients experienced TRAEs leading to discontinuation. The overall safety profile was manageable. In view of the encouraging efficacy signals and manageable safety demonstrated by IBI363 monotherapy, Innovent plans to conduct a Phase 3 registration clinical study in locally advanced or metastatic squamous NSCLC that has failed platinum-based chemotherapy and anti-PD-1 /PD-L1 immunotherapy. As of now, IBI363 has received Breakthrough Therapy (BTD) certification from China CDE and Fast Track Designation (FTD) from the US FDA for squamous NSCLC. Professor Jianya Zhou, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "Lung cancer is the malignant tumor with the highest incidence and mortality rate both globally and in China[1], and it is a major issue endangering public health. Although immunotherapy has completely transformed the treatment landscape of NSCLC, for patients with wild-type NSCLC who have failed immunotherapy, the current standard treatment regimen docetaxel has limited efficacy, with an ORR of less than 20%, a PFS of less than 4 months, and an OS of less than 12 months [2-7]. In recent years, although the exploration of new treatment regimens such as immune combination therapy and antibody drug conjugates (ADCs) has brought new hope, many large-scale Phase 3 clinical studies on NSCLC patients who have failed platinum-based chemotherapy and immunotherapy have not achieved satisfactory results, and most of these studies have not met the primary endpoints[2-6]. Although the TROPION-Lung01 study achieved the primary endpoint of PFS in NSCLC, it did not reach the primary endpoint of OS. Especially in squamous NSCLC, no improvement was observed in PFS/OS/ORR in the experimental group. Therefore, there was a huge and urgent unmet medical need in NSCLC that has failed immunotherapy. As a PD-1/IL-2α-bias bispecific molecule, IBI363 not only shows clinical benefits in both ORR and PFS in immune-resistant NSCLC, but also enables us to see the potential of the tailing effect of immunotherapy to bring long-term survival benefits to patients compared with chemotherapy. We are also more looking forward to the survival data of the long-term follow up in the high dose IBI363 group." Dr. Hui Zhou, Senior Vice President of Innovent, stated: "It is a great pleasure to orally present the latest progress of IBI363 in the field of lung cancer at the ASCO conference. IBI363 shows remarkable efficacy in immune-resistant wild-type nsclc and clinical data suggests better trends in ORR, DCR, PFS and OS at higher doses. We expect longer-term follow-up to bring more mature data and look forward to seeing its potential as an immunotherapy for the long-term survival benefits of patients. Meanwhile, regardless of the expression level of PD-L1, IBI363 has demonstrated a powerful anti-tumor effect in immune-resistant NSCLC (especially squamous NSCLC), suggesting that the effect of IBI363 does not depend on the expression of PD-L1. In the future, it may also bring breakthroughs in cold tumors with low or no expression of PD-L1. We will continue to advance the clinical exploration of IBI363 in NSCLC and other tumor types." About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein) IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2. This approach targets and activates tumor-specific T cells that express both PD-1 and IL-2α, leading to more precise and effective activation of this T cell subpopulation. IBI363 has demonstrated robust antitumor activity in various tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. In response to urgent clinical needs, Innovent is conducting clinical studies in China, the United States and Australia to further explore the efficacy and safety of IBI363 in various tumor indications, including immune-resistant, cold tumors, and front-line treatments. The first pivotal trial of IBI363 was initiated in 2025 for unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. IBI363 has received two fast track designations (FTD) from the U.S. FDA and two breakthrough designations (BTD) from the China NMPA, for the treatment of squamous non-small cell lung cancer and melanoma, respectively. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References [1] Globocan 2022 (version 1.1) - 08.02.2024 [2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733 [3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166 [4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024. [5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023. [6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16. [7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544 SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHICAGO, June 2, 2025 /PRNewswire/ -- ImmuneOncia Therapeutics, Inc. (CEO Heung-Tae Kim) announced interim results today from the ongoing Phase 1b clinical trial of its next-generation CD47-targeting antibody, IMC-002, in combination with lenvatinib for patients with advanced hepatocellular carcinoma (HCC). The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA. The study, part of the dose-expansion phase, evaluated the safety and early efficacy of the combination therapy. IMC-002 demonstrated a favorable safety profile with no reported cases of neutropenia or thrombocytopenia. Mild anemia was observed in 2 of 13 patients (15%), and 96% of adverse events were Grade 1–2, occurring primarily in the first treatment cycle. Among 10 patients evaluable for efficacy, 3 (30%) showed a partial response (PR), while the disease control rate (DCR) reached 80%. The median progression-free survival (PFS) was 8.3 months. Notably, two patients have remained on treatment for over one year, indicating the potential for sustained therapeutic benefit. AI-powered digital pathology analysis showed a 60% objective response rate (ORR) in patients with high CD47 expression on tumor cell membranes, whereas no response was observed in those with low expression - a statistically significant difference (p=0.018). These findings support CD47 expression as a predictive biomarker for response. Professor Jeong-Yong Hong of Samsung Medical Center commented, "The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives. A 30% response rate is particularly promising, especially when compared to the approximately 10% typically observed with current second-line therapies for HCC." CEO Heung-Tae Kim stated, "Two of the three partial responders were resistant to first-line immunotherapy, suggesting IMC-002 may offer a new path forward via macrophage-based innate immunity. We are confident that this combination could redefine second-line treatment for HCC and will enhance our patient selection strategy through AI-driven biomarker analysis." IMC-002 is an IgG4 monoclonal antibody targeting the CD47-SIRPα axis to restore macrophage-mediated phagocytosis of cancer cells. It is a second-generation anti-CD47 antibody designed to minimize binding to normal cells and avoid common toxicities such as hemagglutination and cytopenia. ImmuneOncia is currently conducting Phase 1b trial of IMC-002 in patients with solid tumors. In 2021, the company out-licensed the asset to China's 3D Medicines in a deal worth up to $470 million. Its pipeline also includes the PD-L1 antibody IMC-001 and bispecific antibodies IMC-201 and IMC-202. Following its KOSDAQ listing in May 2025, ImmuneOncia aims to strengthen its global presence in immuno-oncology. About IMC-002 IMC-002 is a novel immune checkpoint inhibitor targeting CD47, a "don't eat me" signal expressed on cancer cells. By blocking the CD47/SIRPα interaction, IMC-002 enhances macrophage-mediated phagocytosis. It is engineered to deliver high efficacy while minimizing binding to red blood cells and avoiding hematologic toxicity. About ImmuneOncia Therapeutics, Inc. Founded in 2016, ImmuneOncia is a South Korean clinical-stage biotech company specializing in immuno-oncology. With expertise in antibody development and translational science, the company is advancing a pipeline of checkpoint inhibitors and bispecific antibodies to address unmet needs in cancer treatment. Media Contact Jiwon Heo ImmuneOncia Therapeutics, Inc. Email: [email protected] Website: SOURCE ImmuneOncia Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED