INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and IASO Biotherapeutics announced updated results from a Phase 1/2 study of Equecabtagene Autoleucel, a CAR T-cell therapy targeting relapsed/refractory multiple myeloma. Presented at the EHA Annual Meeting on June 12, 2022, the data from 79 patients showed an overall response rate (ORR) of 94.9%, with 68.4% achieving complete responses. Safety was manageable, with 94.9% experiencing cytokine release syndrome. The therapy exhibited prolonged persistence and low immunogenicity, suggesting significant potential as a treatment option for this challenging cancer.

Innovent Biologics announced positive results from a Phase 2 study of mazdutide (IBI362), a dual agonist for treating overweight and obesity in Chinese participants. The study met all primary and key secondary endpoints, with participants achieving a mean weight loss of up to 12.6% compared to placebo. Efficacy was dose-dependent, demonstrating significant reductions in body mass index and other metabolic parameters. The treatment was well tolerated, with only mild and transient side effects. The company is preparing to advance to Phase 3 trials following these encouraging results.

Innovent and AnHeart presented updated data on taletrectinib at ASCO 2022, highlighting its efficacy for ROS1-positive non-small cell lung cancer (NSCLC). In 67 TKI-naïve patients, the confirmed objective response rate (cORR) was 92.5%, while in 38 crizotinib-pretreated patients, it was 50%. Patients with brain metastasis showed a 91.7% intracranial cORR. Taletrectinib demonstrated good tolerability with few neurological adverse events, confirming its potential as a next-generation ROS1 inhibitor. Ongoing trials aim to further explore its capabilities against resistant mutations.

Innovent Biologics presented clinical data for IBI110, an anti-LAG-3 monoclonal antibody, at the 2022 ASCO Annual Meeting. The findings from three clinical trials show promising results in treating advanced squamous non-small cell lung cancer (sqNSCLC) and advanced gastric cancer (GC). In a Phase Ia/Ib study, the objective response rate (ORR) was 15.4% in advanced solid tumors, while the first-line therapy for sqNSCLC demonstrated an ORR of 80%. Safety assessments indicated a manageable profile with no treatment-related deaths.

Innovent Biologics and IASO Biotherapeutics announced the acceptance of the New Drug Application (NDA) for Equecabtagene Autoleucel by the China National Medical Products Administration (NMPA). This CAR-T therapy targets relapsed and/or refractory multiple myeloma (R/R MM) and is the first of its kind developed in China. The therapy showed a 94.9% overall response rate in a clinical study. This acceptance comes after the therapy received Breakthrough Therapy Designation in February 2021 and may lead to significant advancements in treatment options for MM patients.

Innovent Biologics has presented preliminary data from a Phase I clinical trial of IBI351 (GFH925), a KRAS^G12C inhibitor, at the 2022 ASCO Annual Meeting. Conducted on 31 patients with advanced solid tumors, the trial highlighted a promising 42.9% overall response rate (ORR) and favorable tolerability. Among 12 non-small cell lung cancer patients receiving higher doses, the ORR was 50%. Notably, IBI351 exhibited no dose-limiting toxicities, with most treatment-related adverse events being mild. The study indicates potential for IBI351 in treating KRAS^G12C mutated cancers in China.

Innovent Biologics has appointed Mr. Gary Zieziula as an independent non-executive director and member of the audit and strategy committees. Zieziula brings over 40 years of global experience in pharmaceuticals, previously leading Kyowa Kirin USA and EMD Serono. His expertise in drug commercialization is expected to complement Innovent's strategy during a crucial growth phase, as the company aims to enhance its global footprint. Innovent, established in 2011, has developed a robust pipeline with 32 assets, including 7 marketed products in China.

Innovent Biologics announced its participation in the 2022 ASCO annual meeting, showcasing clinical data from various trials involving innovative treatments like IBI110, Pemazyre, and others. Key studies include the efficacy of IBI110 in HER2-negative gastric cancer and advanced lung cancer, highlighting promising preliminary results. Additionally, an updated Phase II study on Pemazyre for cholangiocarcinoma was also presented. This event underscores Innovent's commitment to advancing oncology solutions while enhancing patient care.

Innovent Biologics announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for IBI310, in combination with sintilimab, for treating recurrent or metastatic cervical cancer. The designation is based on Phase 2 trial results involving 205 patients, showing a safety profile consistent with previous studies. This designation will facilitate expedited development and review of IBI310, which aims to address the urgent need for better treatment options in this patient population.