I-Glenmark Pharmaceuticals Limited ithole imvume evela kumlawuli wezidakamizwa wase-India, u-Drug Controller General of India (DCGI), ukwenza uhlolo lomtholampilo lweSigaba 1 senoveli yayo ye-molecule encane, i-GRC 54276, i-hematopoietic progenitor kinase 1 (HPK1) inhibitor. I-GRC 54276 ingelinye lamangqamuzana anoveli amaningi aphuma kumhlali waseGlenmark, Innovative Medicines Group, eholwa uDkt. Nikhil Amin, Isikhulu Esiyinhloko Sezesayensi, ogxile ekuthuthukisweni kwamanoveli amabhizinisi amangqamuzana ezidingo zezokwelapha ezingahlangatshezwana nazo. I-HPK1 iyisilawuli esiyinhloko se-T cell, B cell kanye ne-dendritic cell-mediated immune responses, ethuthukisa ukungatheleleki kwe-antitumor ngokuvula kanye nokuqala amaseli e-T. I-GRC 54276 ibonise ikhono lokubulala iseli yesimila ezifundweni zangaphambi komtholampilo njenge-ejenti eyodwa futhi futhi ihlanganiswe nama-checkpoint inhibitors, okuyenza ibe into ebaluleke kakhulu okuhloswe ngayo ku-immuno-oncology.
Ucwaningo luzohlola ukuphepha nokubekezelelana kwe-GRC 54276 njenge-monotherapy, futhi kuhlanganiswe nama-checkpoint inhibitors ezigulini ezinamathumba aqinile athuthukile kanye ne-Hodgkin's lymphoma. I-Glenmark izoqala ukuhlolwa komtholampilo kweSigaba 1 e-India ngo-June 2022, futhi ihlela nokufaka i-IND e-US kanye ne-Clinical Trial Applications eYurophu ukuze kuqalwe uhlelo lokufunda lomtholampilo lomhlaba wonke ngokugcwele.
“Umzamo we-Glenmark kube ukuhlinzeka ngezixazululo ezintsha zokwelapha ezindaweni zayo ezibalulekile zokwelapha. Siyajabula ngokuthi i-molecule yethu yokuqala ye-'Innovative Medicines Group' esanda kwakhiwa ngaphakathi kwe-Glenmark ithole imvume kumlawuli wezidakamizwa wase-India ukuthi iqale uhlolo lomtholampilo lweSigaba 1. Lokhu kuqinisa amandla e-Glenmark akhulayo ocwaningo lwezokwelapha olusha futhi kuyisinyathelo esiseduze ekuhlinzekeni izixazululo eziphelele zokwelashwa komdlavuza,” kusho uGlenn Saldanha, uSihlalo kanye noMqondisi Ophethe, iGlenmark Pharmaceuticals Limited.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Glenmark will initiate Phase 1 clinical trial in India by June 2022, and also plans to file an IND in the US and Clinical Trial Applications in Europe to kick-off a fully global clinical study program.
- GRC 54276 has shown tumor cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology.
- Glenmark Pharmaceuticals Limited received approval from the Indian drug regulator, Drug Controller General of India (DCGI), to conduct a Phase 1 clinical trial of its novel small-molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor.
