INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and IASO Bio have announced a strategic collaboration in cell therapy. IASO Bio will acquire Innovent's rights to FUCASO® (Equecabtagene Autoleucel), including global commercial rights and intellectual property licenses. Innovent will gain an 18% stake in IASO Bio. FUCASO®, a CAR-T product approved in China and the world's first fully human CAR-T product, will be developed, manufactured, and commercialized by IASO Bio. This partnership aims to enhance resources and team integration, focusing on advancing innovative therapeutic solutions.

Innovent Biologics presented its latest Phase 1 clinical data for the anti-CLDN18.2 ADC (IBI343) at the ESMO Gastrointestinal Cancers Congress 2024. This treatment targets advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) patients with high CLDN18.2 expression. Results showed an ORR of 36.7% and DCR of 93.3% at 6 mg/kg, and an ORR of 47.1% and DCR of 88.2% at 8 mg/kg. The median progression-free survival at 6 mg/kg was 6.8 months. Most treatment-related adverse events were grade 1-2, with low grade 3 gastrointestinal toxicities and no interstitial lung disease. Innovent plans to explore IBI343 in combination therapies and other tumor types.

Innovent Biologics provided updates on its Mazdutide GLORY-1 study and the company's biomedicine pipeline at an investor conference call on June 25, 2024. The Phase 3 GLORY-1 study, presented at the 2024 ADA Scientific Meeting, showed significant weight loss and liver fat reduction among overweight or obese adults in China. Mazdutide, a GLP-1R/GCGR dual agonist, reduced weight by 14.3% and liver fat by 80.2% after 48 weeks, also improving multiple cardiovascular risk indicators. The treatment proved safe and well-tolerated. Innovent is pursuing additional indications for mazdutide and advancing its cardiovascular and metabolic disease pipeline with products like SINTBILO, IBI128, and IBI3016. The company is also progressing in autoimmune and ophthalmological treatments with candidates like SULINNO, picankibart, and IBI311.

Innovent Biologics presented results from its first Phase 3 study of the drug mazdutide for weight management at the ADA Scientific Sessions 2024. The GLORY-1 study, involving 610 Chinese adults, demonstrated significant weight loss, reduced liver fat, and improved cardiometabolic risk factors compared to placebo. Mazdutide achieved weight reduction endpoints, with differences in mean weight loss reaching -14.31% at 48 weeks for the highest dose. The drug also showed favorable safety and tolerability. The new drug application for mazdutide is under review by China's National Medical Products Administration, with potential to offer a new treatment for obesity and related conditions.

Innovent Biologics announced results from their Phase 3 GLORY-1 study, revealing a significant reduction in liver fat content using mazdutide, a GLP-1R and GCGR dual agonist. The study involved 610 Chinese adults with obesity or overweight, showing an average liver fat reduction of 80.2% in participants with a baseline LFC ≥10%. The 48-week trial demonstrated dose-dependent improvements in liver fat content, body weight, and other metabolic parameters, outperforming placebo. These findings suggest mazdutide's potential in treating MAFLD and MASH.

Innovent Biologics shared updates on its oncology pipeline during a recent investor meeting. The company highlighted the progress of multiple cancer drug candidates, including IBI363, IBI343, and IBI389. IBI363, a PD-1/IL-2 bispecific antibody, showed promising results in various cancer types. IBI343, the first ADC drug with initial breakthrough efficacy in pancreatic cancer, demonstrated a 40% ORR in Phase 1 trials. IBI389, a bispecific antibody targeting CLDN18.2/CD3, showed notable anti-tumor activity in pancreatic and gastric cancers, with a 29.6% ORR among participants. Innovent aims to advance these drugs through further clinical trials, leveraging its

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.