Welcome to our dedicated page for Innovent Biologi news (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologi stock.
Innovent Biologics, Inc. develops, manufactures and commercializes biopharmaceutical medicines for oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas. News from Innovent centers on product approvals and commercial updates in China, clinical and preclinical data for pipeline assets, medical-congress presentations, and partner-reported development updates. Recurring drug and program references include mazdutide for type 2 diabetes, IBI363 in cancer immunotherapy, IBI324/OLN324 for retinal disease, tigulixostat/IBI128 for gout, and immunology assets such as picankibart/IBI112, IBI3013 and IAR129.
Innovent Biologics announced that its drug IBI343, designed for advanced pancreatic ductal adenocarcinoma (PDAC), received Fast Track Designation (FTD) from the U.S. FDA. IBI343 is a TOPO1i anti-CLDN18.2 ADC, aimed at patients with relapsed or refractory PDAC after one prior line of therapy. Preliminary Phase 1 results showed a 40% overall response rate (ORR) in a 6 mg/kg dose group among 10 evaluable PDAC patients with specific biomarkers. Pancreatic cancer remains hard to treat, with second-line options and poor survival rates. Innovent plans to further investigate IBI343's efficacy and safety in combination therapies and other solid tumors.
Innovent Biologics will present multiple clinical study results of mazdutide at the ADA's 84th Scientific Sessions in Orlando from June 21-24. The company will showcase findings from the Phase 3 GLORY-1 study on Chinese adults with obesity and overweight, an exploratory analysis of GLORY-1 on liver steatosis, and a Phase 2 study of mazdutide 9 mg in adults with obesity. Presentations include an oral ePoster on June 23 and two poster sessions. Mazdutide is the first GLP-1R/GCGR dual agonist to succeed in a Phase 3 registration study for obesity and overweight, and results from ongoing Phase 3 GLORY-2 will also be shared.
Innovent Biologics presented data from a Phase 1b study at the 2024 ASCO Annual Meeting, revealing encouraging results for IBI310 in combination with sintilimab as a neoadjuvant treatment for colon cancer. The study showed a significantly higher pathologic complete response (pCR) rate of 80% for the combination therapy compared to 47.7% for sintilimab alone. The therapy also received Breakthrough Therapy Designation (BTD) from China's NMPA. Innovent has initiated a Phase 3 trial (Neoshot) to further evaluate this promising combination.
Innovent Biologics presented clinical data on its anti-CLDN18.2/CD3 bispecific antibody, IBI389, at the 2024 ASCO Annual Meeting. The Phase I study involved patients with advanced pancreatic cancer (PDAC) and gastric or gastroesophageal tumors (G/GEJC). Key findings include a 29.6% objective response rate (ORR) for PDAC at the recommended phase 2 dose, and a 30.8% ORR for G/GEJC. The disease control rates were 70.4% for PDAC and 73.1% for G/GEJC. Safety data indicated tolerability with no new safety signals. The study highlights IBI389's potential as an innovative treatment for difficult-to-treat cancers, especially in patients with treatment options and poor prognosis.
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.