Kaomi ma aneʻi e hōʻike i kāu mau hae ma kēia ʻaoʻao a uku wale no ka holomua

Nuhou Uea

'Apono 'ia no ke a'o hou 'ana i nā ma'i ma'i pa'a a me Non-Hodgkin Lymphoma

i kakauia ma hoʻoponopono

Ua hoʻolaha ʻo Antengene Corporation Limited i kēia lā ua ʻae ʻo China National Medical Products Administration (NMPA) i ke aʻo ʻana i ka Phase I o ATG-101 (ka noiʻi PROBE-CN) no ka mālama ʻana i nā maʻi maʻi paʻa kiʻekiʻe / metastatic a me B-cell non-Hodgkin lymphoma (B). -NHL).

ʻO ATG-101 kahi antibody bispecific novel i hoʻolālā ʻia e pale i ka paʻa ʻana o ka immunosuppressive PD-1/PD-L1 a me ka hoʻoulu ʻana i ka hoʻoulu ʻana i ka 4-1BB, no laila e hoʻoulu ai i nā hopena anti-tumor immune, ʻoiai e hāʻawi ana i ka hana anti-tumor i hoʻonui ʻia, me kahi ʻoi aku ka maikaʻi o ka ʻike palekana. Ma nā haʻawina preclinical, ua hōʻike ʻo ATG-101 i ka hana anti-tumor koʻikoʻi i nā ʻano holoholona o nā maʻi maʻi kūʻē a me nā mea i holomua ma ka mālama anti-PD-1/L1. Eia kekahi, ua hōʻike pū ʻo ATG-101 i kahi kūlana palekana maikaʻi loa i nā haʻawina toxicology GLP.

ʻO ka Halemai ʻo Shanghai Hikina o ke Kulanui ʻo Tongji ke kahua alakaʻi no ke aʻo ʻana, e mālama ʻia ma nā kikowaena ʻehā ma Kina. Hoʻolālā ʻia kēia haʻawina open-label, multicenter Phase I e loiloi i ka palekana a me ka ʻae ʻana o ka monotherapy ATG-101 i hoʻohana ʻia i loko o ka intravenously i nā maʻi me nā maʻi maʻi paʻa kiʻekiʻe/metastatic a me B-NHL. E mālama ʻia ke aʻo ʻana i ʻelua mau ʻāpana (ka piʻi ʻana o ka nui a me ka hoʻonui ʻia).

Ua ʻōlelo ʻo Polofesa Ye Guo, Hope Luna Hoʻokele o ka Medical Oncology ma Shanghai East Hospital o Tongji University, Luna Hoʻokele o ke kikowaena o ka haukapila no nā hoʻokolohua Phase I, a me ka mea noiʻi nui o ke aʻo ʻana: , ka lapaʻau i hoʻopaʻa ʻia, a me ka immunotherapy, a me nā mea ʻē aʻe). ʻO ka poʻe maʻi me kēlā mau ʻano maʻi maʻi ʻaʻole i hoʻokō koke ʻia. Ke kākoʻo nei nā hōʻike mauna i nā pono kūpono o nā antibodies bispecific ma ke ʻano he ʻano hoʻohiki no ka mālama ʻana i nā maʻi maʻi ʻino. ʻO ATG-101 kahi moʻolelo PD-L1/4-1BB bispecific antibody. Ua hoʻolālā ʻia e hoʻohui i ka pilina kiʻekiʻe no PD-L1 a me ka hoʻoulu ʻana o ke kūlana o 4-1BB, i manaʻo ʻia e hōʻemi i ka hopena o ka hepatoxicity pili 4-1BB. ʻO koʻu hauʻoli nui e alakaʻi i ka hoʻokolokolo PROBE-CN, ke aʻo mua o ka ATG-101 ma Kina. E hana maʻalahi kaʻu hui me nā mea noiʻi ʻē aʻe a me ka hui noiʻi o Antengene. Manaʻo mākou e hāʻawi ʻo ATG-101 i kahi koho lapaʻau maikaʻi a palekana no nā poʻe maʻi me nā maʻi maʻi.

Ua ʻōlelo ʻo Dr. Jay Mei, ka mea nāna i hoʻokumu, luna hoʻomalu a me Luna Nui o Antengene: "I loko o kahi manawa pōkole loa, ua holomua ʻo ATG-101 mai ka pae pre-clinical ma o kahi ʻano o nā hanana hoihoi, me nā ʻae ʻana o IND ma Australia a me ka US. , a me ka ʻae hou loa e ka NMPA ma Kina no ke aʻo ʻana i ka ATG-101 i nā maʻi me nā maʻi maʻi holomua / metastatic solid a me B-NHL. Ua hauʻoli nui mākou i nā holomua o ka papahana a ke manaʻo nei mākou e kōkua kēia haʻawina koʻikoʻi i ka holomua ʻana i kahi lāʻau lapaʻau maikaʻi no nā poʻe maʻi me nā maʻi maʻi paʻa a me ka NHL i hoʻi hou a lilo i refractory i nā anti-PD-1/L1 therapies.

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