HM99462 / Hanmi - LARVOL DELTA

Hanmi Pharmaceutical announced on the 29th that it had presented…research results as posters on…selective HER2 exon 20 insertion mutation inhibitor, and SOS1 inhibitor (HM99462) at the ’EORTC-NCI-AACR 2024’ international cancer conference…[Google Translation] (Hanmi Press Release) - "Hanmi's selective HER2 inhibitor minimizes side effects by increasing selectivity for wild-type EGFR (epidermal growth factor receptor), and exhibits anticancer activity in animal models of HER2 exon 20 insertion mutations and HER2 wild-type tumors through oral administration...Hanmi Pharmaceutical demonstrated the efficacy of inhibiting brain metastasis by confirming a decrease in the level of brain metastasis compared to the control group...HM99462 exhibited anticancer activity in various KRAS mutant solid cancer cell lines, including KRAS G12C as well as G12D/V/S, and G13D, by inhibiting the protein binding between KRAS-SOS1 regardless of KRAS mutation...it demonstrated a strong synergistic effect through vertical inhibition with EGFR mutation inhibitors, and confirmed the possibility of treating EGFR mutant lung cancer. Hanmi Pharmaceutical plans to apply for an investigational new drug (IND) plan to enter phase 1 clinical trials in the first half of next year."

New P1 trial • Preclinical • Lung Cancer • Oncology • Solid Tumor

HM99462, a novel SOS1 inhibitor, induces tumor regression and synergistic effect with KRAS or EGFR targeted therapy in NSCLC (EORTC-NCI-AACR 2024) - "Through our various studies, HM99462 demonstrated excellent inhibitory activity against cancers with EGFR mutations, suggesting its potential as an effective therapeutic agent targeting tumors with hyperactivated RTK-RAS-MAPK signaling. Furthermore, HM99462 has shown potential to overcome the limitations of mutant-selective EGFR inhibitors when used in combination. HM99462 is planned to initiate clinical studies in late 2024."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Hanmi Pharmaceutical unveils new anticancer drug candidate targeting KRAS [Google translation] (Daily Pharm) - "Hanmi Pharmaceutical participated in the '2023 AACR-NCI-EORTC' held in Boston, USA from the 11th to the 15th of this month (local time) and presented a poster with the results of research on 'HM99462', which is being developed as an innovative anticancer drug....Hanmi Pharmaceutical explained that HM99462 showed anticancer activity in various KRAS mutant solid cancer cell lines, including G12D/V/S, G13D as well as KRAS G12C, by inhibiting the protein binding between KRAS-SOS1 regardless of the KRAS mutation type....Based on these research results, Hanmi Pharmaceutical is currently preparing to apply for an investigational new drug (IND) and plans to begin phase 1 clinical trials as early as next year."

IND • New P1 trial • Preclinical • Oncology • Solid Tumor

HM99462, a Novel potent SOS1 inhibitor, induces tumor regressions in combination with KRAS G12C inhibitor, MEK inhibitor, or EGFR mutant inhibitor. (AACR-NCI-EORTC 2023) - No abstract available

Combination therapy • Oncology • KRAS

Hanmi Pharm to unveil new drug pipelines at AACR 2023 (Korea Biomedical Review) - "Hanmi Pharmaceutical said it would disclose new drug research projects at the upcoming annual meeting of the American Association for Cancer Research (AACR 2023) in the U.S....The new pipelines that Hanmi Pharmaceutical will unveil at the AACR include LAPSIL-2analog (HM16390), EZH1/2 dual inhibitor (HM97662), SOS1 inhibitor (HM99462), YAP/TAZ-TEAD inhibitor, mRNA anti-cancer vaccine, and PD-L1/4-1BB BsAb (BH3120)....On April 17, Hanmi is to disclose the results of its preclinical candidate BH3120....Beijing Hanmi Pharmaceutical and Hanmi plan to submit a phase 1 investigational new drug application to the U.S. FDA within this month."

Clinical data • IND • Preclinical • Oncology

A novel SOS1 inhibitor, HM99462 demonstrates antitumor activity against KRAS-mutant cancers (AACR 2023) - "And it has the potential to overcome the limitations of KRAS G12C or MEK inhibitor through combination. HM99462 is currently in IND enabling GLP-toxicity studies, planned to initiate clinical study in early 2024."

Oncology • KRAS

24 domestic pharmaceutical companies “Let’s go to AACR”… K-Bio, candidate material ’show off’ (Medi-consumer News) - "Hanmi Pharmaceutical plans to introduce the results of its research on six candidate substances from the 17th to the 19th. The antitumor activity of a novel YAP/TAZ-TEAD inhibitor targeting the Hippo pathway in solid cancer and the antitumor effect of HM99462, an SOS1 inhibitor, against KRAS mutant cancer will be explained....LegoChem Bioscience will share the results of research on immuno-anticancer drugs using the low-molecular-weight compound 'LCB33', a new method in which existing immuno-anticancer drugs maximize drug effects by regulating the tumor microenvironment."

Preclinical • Oncology • Solid Tumor