Innovent Biologi - IVBIY STOCK NEWS

Innovent Biologics announced updated data from its pivotal Phase 2 TRUST-I study of taletrectinib, a next-generation ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting. The study involved 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) in China. Results showed a 91% confirmed objective response rate (cORR) in ROS1 TKI-naïve patients and a 52% cORR in those previously treated with crizotinib. Taletrectinib demonstrated favorable outcomes in patients with brain metastases and resistance mutations. The median duration of response and progression-free survival were not reached in TKI-naïve patients after a median follow-up of 23.5 months, while TKI-pretreated patients had a median duration of response of 10.6 months and median progression-free survival of 7.6 months. The safety profile was consistent with previous reports. Two new drug applications have been accepted for priority review by China's NMPA.

Innovent Biologics presented Phase 1 clinical data of IBI343 (TOPOi anti-CLDN18.2 ADC) for advanced pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancer (BTC) at the 2024 ASCO Annual Meeting. The study involved 35 patients, with 25 undergoing at least one post-baseline tumor evaluation. Results showed a 28% objective response rate (ORR) and an 80% disease control rate (DCR). In the 6 mg/kg dose group, the ORR was 38.5% and DCR was 84.6%. Treatment-related adverse events (TRAEs) affected 80% of subjects, with anemia being the most common. No TRAEs led to death.

Innovent Biologics announced publication of Phase 2 TRUST-I study results in the Journal of Clinical Oncology and at the 2024 ASCO Annual Meeting. The study evaluated taletrectinib in 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). Tumor shrinkage was observed in 91% of ROS1 TKI-naïve and 52% of TKI-pretreated patients. Taletrectinib showed efficacy in treating brain metastases and resistance mutations. Median follow-up was 23.5 months for TKI-naïve and 9.7 months for TKI-pretreated patients. Median duration of response was not reached for TKI-naïve and was 10.6 months for TKI-pretreated. Two new drug applications have been accepted by China's NMPA with priority review. The safety profile showed low incidence of neurologic adverse events.

Innovent Biologics presented Phase 1 clinical data for its novel PD-1/IL-2α bispecific antibody fusion protein (IBI363) at the 2024 ASCO Annual Meeting. The study targets advanced solid tumors, including melanoma, colorectal cancer, and other types. Key findings showed that IBI363 demonstrated promising efficacy and safety, with a 28.1% overall response rate (ORR) in melanoma and 12.7% ORR in colorectal cancer. A total of 25.4% of melanoma subjects had baseline liver metastasis, and 61.2% had received at least two prior systemic therapies. In colorectal cancer, 61.8% had liver metastases at baseline, and 76.5% had undergone three or more prior treatments. Common adverse events included arthralgia, hyperthyroidism, and anemia. No treatment-related deaths were reported. Additional data for non-small cell lung cancer will be presented at the ESMO Virtual Plenary later this month.

Innovent Biologics announced that its recombinant antibody injection, picankibart (IBI112), has successfully met all primary and key secondary endpoints in the Phase 3 CLEAR-1 clinical trial for moderate to severe plaque psoriasis. Conducted across multiple centers with 500 participants, the study demonstrated that over 80% of subjects achieved a ≥90% improvement in their Psoriasis Area and Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of clear or almost clear (0 or 1) after 16 weeks. These positive results were sustained for 52 weeks, with no new safety signals identified. Innovent plans to submit a New Drug Application (NDA) to China's National Medical Product Administration (NMPA). This successful trial positions picankibart as a potential best-in-class treatment with convenient dosing every 12 weeks.

Innovent Biologics announced that the New Drug Application (NDA) for their recombinant anti-IGF-1R antibody, IBI311, has been accepted and given priority review by the China National Drug Administration for treating Thyroid Eye Disease (TED). This marks the first submission of an anti-IGF-1R antibody in China. The NDA acceptance is based on positive results from the Phase 3 RESTORE-1 trial, which showed significant improvements in proptosis, disease activity, and quality of life with a favorable safety profile. Detailed results will be presented in 2024. TED, an autoimmune disease affecting eye tissues, lacks effective treatment options in China, making IBI311's approval potentially impactful for patients. Innovent is enhancing its portfolio in ophthalmology, autoimmunity, and other major diseases.

Innovent Biologics announced that it will present clinical data on two of its innovative treatments, IBI363 and IBI343, at upcoming conferences in June 2024. IBI363, a PD-1/IL-2 bispecific antibody fusion protein, will be discussed at the ESMO Virtual Plenary on June 13-14, 2024. IBI343, an anti-Claudin18.2 antibody-drug conjugate, will be presented at the ESMO Gastrointestinal Cancers Congress on June 26-29, 2024. The presentations will focus on early-phase clinical studies in patients with advanced solid tumors and gastric/gastro-esophageal junction adenocarcinoma. Dr. Hui Zhou, Senior VP at Innovent, emphasized the potential efficacy and safety of these treatments, highlighting Innovent's commitment to addressing unmet medical needs in cancer therapy.

Innovent Biologics, Inc. announced the successful results of the Phase 3 clinical trial of mazdutide in Chinese patients with type 2 diabetes. Mazdutide demonstrated superior glycaemic control compared to dulaglutide, along with multiple cardiometabolic benefits such as weight loss, improved blood lipid, blood pressure, and liver enzymes. The study included 731 subjects and showed mazdutide's superior glucose-lowering efficacy and weight loss benefits. Mazdutide also displayed favorable safety and tolerability profiles, with gastrointestinal adverse reactions being the most common. The drug is the first GLP-1R/GCGR dual agonist in regulatory review status, with plans for an NDA submission for chronic weight management. Overall, mazdutide showcased promising results in the treatment of type 2 diabetes.

Innovent Biologics, Inc. receives NMPA Breakthrough Therapy Designation for IBI343 as monotherapy for advanced gastric cancer. The designation is based on promising Phase 1 study results showing safety, tolerability, and antitumor activity in advanced GC patients. Innovent plans to conduct a Phase 3 clinical trial soon. The company aims to provide effective third-line treatment options for GC patients in need.