GenFleet (Beijing) Therapeutics Co., Ltd.

Recently, Innovent Biologics, Inc./GenFleet Therapeutics Co., Ltd. co-developed GF-105 marketing authorization application (NDA) was accepted by the CDE and included in the priority review process for patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have received at least one systemic therapy. GFH925 (IBI351) is the first KRAS G12C inhibitor in China to have its NDA submitted for acceptance into the priority review process. In September 2021, Innovent and Genfleet announced that they had entered into an exclusive global licensing agreement, under which Innovent, as the exclusive partner, has been granted the development and commercialization rights to GFH925 in China, including Mainland China, Hong Kong, Macau and Taiwan, and has global development and commercialization rights. commercialization rights, with an option for global development and commercialization rights. About RBD7022GF-105 is a small molecule drug developed by GenFleet Therapeutics (Shanghai) Co., Ltd. It is designed to target the KRAS G12C mutation, which is associated with various types of cancers. The active indications for GF-105 include KRAS G12C mutant Non-small Cell Lung Cancer, KRAS G12C mutant non-squamous non-small cell lung cancer, KRAS G12C mutant Colorectal Cancer, Non-Small Cell Lung Cancer, KRAS G12C mutation Solid Tumors, Advanced Malignant Solid Neoplasm, Advanced Lung Non-Small Cell Carcinoma, and Advanced Lung Non-Squamous Non-Small Cell Carcinoma. GF-105 has reached the highest phase of development, which is NDA/BLA (New Drug Application/Biologics License Application) globally. Click the image below to directly embark on the exploration journey with the RBD7022! According to the data disclosed at the 2023 AACR conference: As of February 10, 2023, among the 67 evaluable NSCLC (non-small cell lung cancer) patients, the ORR (Objective Response Rate) was 61.2%, and the DCR (Disease Control Rate) was 92.5%; particularly, the 600mg BID (twice daily) dosage group (recommended Phase 2 Dose, RP2D) demonstrated superior efficacy, with an ORR of 66.7% (20 out of 30 evaluable patients), including a confirmed ORR (cORR) of 53.3% (16 out of 30), and a DCR of 96.7%. Additionally, regarding CRC (colorectal cancer) indications, as per the data released at the 2023 ASCO conference: As of February 16, 2023, a total of 54 patients with advanced colorectal cancer were included in the analysis. In the 600mg BID dosage group, 42 patients had undergone at least one tumor assessment, with an ORR of 42.9% (18 out of 42), a cORR of 31.0% (13 out of 42), and a DCR of 88.1% (37 out of 42). About GenFleet Therapeutics Co., Ltd.GenFleet Therapeutics Co., Ltd. is a relatively young biomedicine organization that has made significant progress in its drug development efforts. With a strong focus on Neoplasms and a diverse range of therapeutic areas, the company is actively working towards developing innovative treatments for various diseases. The pipeline indicates a focus on early-stage development, with a significant number of drugs in the preclinical stage. However, further progress is needed to advance these drugs into later stages of development and ultimately gain regulatory approval. Since its establishment in 2017, GenFleet has established over ten proprietary "globally innovative" large and small molecule projects, with multiple products entering global multi-center clinical trials in China, Europe, the United States, and Australia, of which more than five clinical studies have entered the Phase II application and development stage. 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IBI351 (GFH925) is an irreversibly covalent inhibitor of KRASG12C. Previously, a pooled analysis of two phase I studies reported preliminary efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer (CRC) harboring KRASG12C mutation (Ying Yuan, et al., ASCO 2023). On 2 Dec 2023, the updated results of these two studies with extended follow-up were presented in 2023 ESMO_ASIA. IBI351's R&D Progress IBI351, also called GF-105, is a small molecule drug developed by GenFleet Therapeutics (Shanghai) Co., Ltd. It is designed to target the KRAS G12C mutation, which is associated with various types of cancers. The drug has shown potential therapeutic benefits in the treatment of neoplasms, respiratory diseases, and digestive system disorders. According to the Patsnap Synapse, IBI351 has reached the highest phase of development globally, with NDA/BLA status. And the clinical trial distributions for IBI351 are primarily in China and Spain. The key indication is Non-Small Cell Lung Cancer. Detailed Clinical Result of IBI351 This latest clinical trial (NCT05005234; NCT05497336) was designed to investigate the efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation. In this study, eligible metastatic CRC patients (pts) with KRASG12C were enrolled. Pts received IBI351 (GFH925) orally at dose levels of 700mg once daily (QD) or 450/600/750mg twice daily (BID). The primary endpoint was objective response rate (ORR) assessed by investigator per RECIST v1.1. The result showed that as of June 13, 2023, a total of 56 pts were enrolled (median age: 58.0 years; male: 60.7%; ECOG PS 1: 73.2%; ≥2 prior lines of treatment: 60.7%; liver metastasis: 60.7%). The median treatment duration was 172.5 days (range: 8-481) and 26 pts (46.4%) were still on treatment. For 48 pts at 600mg BID, confirmed ORR was 45.8% (95%CI: 31.4%-60.8%) and disease control rate (DCR) was 89.6% (95%CI: 77.3%-96.5%). Median duration of response (DOR) was not reached with events occurring in 5 (22.7%) pts. DOR rates were 65.5% (95%CI: 34.4%-84.5%) at 6 months and not reached at 9 months. In pts of all dose levels, treatment-related adverse events (TRAEs) occurred in 53 (94.6%) pts while majority of them were grade 1-2. Grade 3 TRAEs occurred in 13 (23.2%) pts. Neither grade 4-5 TRAEs nor treatment-related serious adverse events (TRSAEs) occurred. The most common TRAEs included anemia (48.2%), white blood cell count decreased (30.4%), blood bilirubin increased (26.8%) and pruritus (26.8%). TRAEs leading to dose reduction and interruption occurred in 6 (10.7%) and 12 (21.4%) pts. No TRAEs leading to treatment discontinuation or death occurred. It can be concluded that IBI351 (GFH925) monotherapy showed promising durable efficacy and manageable safety in metastatic CRC harboring KRASG12C mutation. During longer follow-up, these two ongoing studies are expected to provide more robust evidence. How to Easily View the Clinical Results Using Synapse Database? If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need.  Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name.  A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more.  If you would like to view more information about this result, you can go to the result detail page by clicking on the title.  Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc.  In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data.  Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

On 14 Apr 2023, the data from phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors was updated at the AACR Congress. GF-105's R&D ProgressGF-105 is a small molecule drug developed by GenFleet Therapeutics (Shanghai) Co., Ltd. It falls under the category of biomedicine and is primarily targeted towards KRAS G12C, a specific mutation found in various types of cancers. The drug is being developed for the treatment of neoplasms, respiratory diseases, and digestive system disorders. According to the Patsnap Synapse, GF-105 has reached the highest phase of clinical development globally, which is Phase 3. And the clinical trial areas for GF-105 are primarily in the China and Spain. The key indication is Non-Small Cell Lung Cancer.  Detailed Clinical Result of GF-105This phase I study (NCT05005234) was aimed to assess the efficacy and safety of IBI351 (GFH925) in patients (pts) with advanced solid tumors harboring KRAS p.G12C mutation.  In this study, pts with locally advanced, recurrent or metastatic solid tumors with KRASG12C mutation for whom standard therapy had failed were enrolled. Phase I dose escalation had an accelerated titration design for dose level 250mg once daily (QD) and a Bayesian optimal interval (BOIN) design with 450-900mg QD and 450-750mg twice daily (BID). The primary endpoints were safety and tolerability. The secondary endpoints were pharmacokinetics (PK), anti-tumor activity of IBI351 (GFH925) monotherapy per RECIST v1.1, and overall survival.  The result showed that as of November 30th, 2022, 74 pts (1 at 250mg QD, 3 at 450mg QD, 9 at 700mg QD, 5 at 900mg QD, 21 at 450mg BID, 31 at 600mg BID and 4 at 750mg BID; 62 men, 12 women; median age: 64 yrs, range: 42-76 yrs) were enrolled, among whom 67 pts had non-small cell lung cancer (NSCLC). Among 67 NSCLC pts, 44.8% pts received ≥2 prior lines of treatment (tx), 38.8% pts had brain metastases; adenocarcinoma was the most common histology (n=66, 98.5%). All 74 pts were included for safety analysis. No dose-limiting toxicity (DLT) were observed in any dose cohorts. The overall safety profile was consistent with the latest previous report, with no new safety signals identified. As of December 15th, 2022, among 67 response-evaluable NSCLC pts across all dose levels, the ORR (by investigator assessment) was 58.2% (95% CI, 45.5-70.2), and the confirmed ORR was 44.8% (95% CI, 32.6-57.4); the disease control rate (DCR) was 92.5% (95% CI, 83.4-97.5). At the 600mg BID dose level (RP2D), the ORR was 63.3% (95% CI, 43.9-80.1), and the confirmed ORR was 50.0% (95% CI, 31.3-68.7), the DCR was 96.7% (95% CI, 82.8-99.9). With a median progression-free survival (PFS) follow-up of 5.5 months (95% CI, 5.3-6.8) for NSCLC pts at the 600mg BID dose level, 21 (70%) pts were continuing treatments, and the median duration of response (DoR) and PFS were not reached. Thirteen out of 15 confirmed responders were still in response. It can be concluded that IBI351 (GFH925) was well-tolerated across all doses explored in patients with advanced solid tumors harboring KRAS p.G12C mutation. The data also demonstrated promising efficacy and durable response of IBI351 (GFH925) in previously treated advanced NSCLC. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need.  Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name.  A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more.  If you would like to view more information about this result, you can go to the result detail page by clicking on the title.  Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc.  In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data.  Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!