Innovent Biologi - IVBIY STOCK NEWS

Innovent Biologics and AnHeart Therapeutics announced that the Center for Drug Evaluation (CDE) of China's NMPA granted Breakthrough Therapy Designation to taletrectinib for ROS1-positive non-small cell lung cancer (NSCLC). This designation is based on Phase 2 trial results where taletrectinib showed a 90.5% objective response rate in treatment-naïve patients. The drug targets ROS1 fusion mutations, which affect 1-2% of NSCLC cases, and demonstrated good safety and efficacy profiles. Ongoing trials aim to further evaluate its potential for NSCLC patients.

Innovent Biologics announced that the first patient has been dosed in a phase 1 clinical trial for IBI325, a proprietary CD73 antibody targeting advanced solid tumors. This open-label study aims to assess safety, tolerability, and preliminary efficacy while establishing the recommended dose for future studies. IBI325 is designed to counteract immunosuppression in the tumor microenvironment, potentially enhancing the effectiveness of existing cancer therapies. Preclinical studies suggest robust anti-tumor activity, raising hopes for addressing unmet medical needs in cancer treatment.

Innovent Biologics has announced the first patient dosing of its universal "modular" CAR-T cell therapy, IBI345, for advanced Claudin18.2-positive solid tumors as part of an investigator-initiated trial. This milestone follows Innovent's collaboration with Roche, initiated in June 2020. The trial aims to evaluate the safety and preliminary efficacy of IBI345, which utilizes a unique mechanism of action to enhance treatment for aggressive tumors such as gastric and pancreatic cancers. The ongoing research may offer new treatment avenues for patients in urgent need.

Innovent Biologics has announced the successful achievement of primary endpoints in two Chinese registration studies for the recombinant full-human anti-PCSK-9 monoclonal antibody, IBI306. The CREDIT-1 and CREDIT-4 studies demonstrated significant reductions in LDL-C levels in patients with hypercholesterolemia. Following three completed key registration studies, Innovent plans to submit a new drug application for IBI306 targeting primary hypercholesterolemia and combined hyperlipidemia. These results emphasize the drug's potential in offering effective treatment options for cardiovascular disease risk in China.

Innovent Biologics and IASO Biotherapeutics announced that the FDA has granted Orphan Drug Designation to their BCMA-targeted CAR T-cell therapy, IBI326, for relapsed/refractory multiple myeloma. This designation will expedite development and provides incentives such as clinical study support and seven years of market exclusivity upon approval. Previously, IBI326 received Breakthrough Therapy Designation in China. This development is significant given the increasing incidence of multiple myeloma, with new cases in the U.S. projected to rise from 32,300 in 2020 to 37,800 by 2025.

The FDA's Oncology Drug Advisory Committee voted for additional clinical trials for sintilimab, an investigational PD-1 inhibitor, before considering its first-line treatment application for non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted in China. The committee highlighted a need for data validating the drug's applicability to the U.S. population. Innovent and Lilly, who are collaborating on sintilimab, acknowledged the disappointment but remain optimistic about its potential and will continue working with the FDA.

Innovent Biologics has received approval from the Hong Kong Department of Health for Pemazyre® (pemigatinib) to treat adults with locally advanced or metastatic cholangiocarcinoma exhibiting FGFR2 fusion or rearrangement after prior therapy. This marks the first approval of a tyrosine kinase inhibitor for this cancer type in Hong Kong. The approval follows previous approvals in Taiwan and NDA acceptance in Mainland China. The FIGHT-202 study demonstrated an overall response rate of 37.0% with a median duration of response of 8.08 months. The treatment was generally well tolerated.

Innovent Biologics and Eli Lilly announced the final outcomes of Phase Ib study NCT04072679, which evaluated sintilimab with bevacizumab biosimilar for treating advanced hepatocellular carcinoma (HCC). Conducted in China, the study included 50 patients, showing an overall response rate of 34%, with disease control at 78%. Notably, median progression-free survival was 10.5 months and overall survival was 20.2 months. Safety profiles were consistent with previous studies, but side effects included hypertension (32%) and proteinuria (26%). The findings may advance individualized treatment options for HCC.

Sana Biotechnology, Inc. has entered into a license agreement with IASO Biotherapeutics and Innovent Biologics for a clinically validated fully-human BCMA CAR construct. This agreement enables Sana to utilize the BCMA CAR construct for in vivo gene therapy and ex vivo hypoimmune cell therapy applications. IASO Bio and Innovent are set to receive an upfront payment along with potential milestone payments of up to $204 million. The licensed construct is part of a promising CAR T therapy for relapsed/refractory multiple myeloma, which has shown a high overall response rate of 94.9% in clinical trials.