INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics presented new clinical data of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2024 ESMO Virtual Plenary. The Phase 1 study showed promising results in various advanced solid tumors, including NSCLC, melanoma, and colorectal cancer. Over 300 subjects were treated with IBI363, showing good tolerability and safety. Notable efficacy was observed in IO-treated squamous NSCLC and IO-naïve mucosal melanoma. The overall objective response rate (ORR) and disease control rate (DCR) for various doses were highlighted, with the 3mg/kg dose showing the highest efficacy. Innovent plans to continue exploring IBI363's potential in further studies.

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.