Hoʻokaʻawale ʻia ʻo Orphan Drug no ka mālama ʻana i ka follicular Lymphoma

A HOLD Hoʻokuʻu ʻole 2 | eTurboNews | eTN
i kakauia ma Linda Hohnholz

ʻO CASI Pharmaceuticals, Inc., he hui biopharmaceutical US e kālele ana i ka hoʻomohala ʻana a me ka hoʻolaha ʻana i nā lāʻau lapaʻau hou a me nā huahana lāʻau lapaʻau, hoʻolaha i kēia lā, ua hāʻawi ka US Food and Drug Administration (FDA) i ka Orphan Drug Designation (ODD) i kāna hoa BioInvent International AB, no ka mea. ʻO BI-1206, he anti-FcyRllB antibody noiʻi, no ka mālama ʻana i ka follicular lymphoma (FL), ke ʻano maʻamau o ka lymphoma Non-Hodgkin (NHL) e ulu lohi nei.

ʻO BI-1206 ka moho lāʻau alakaʻi o BioInvent a ke noiʻi ʻia nei i ʻelua mau hoʻokolohua Phase 1/2. Ke loiloi nei kekahi i ka hui BI-1206 me rituximab no ka mālama ʻana i ka lymphoma Non-Hodgkin, ʻo ia hoʻi nā poʻe maʻi me FL, MCL a me marginal zone lymphoma (MZL) i hoʻi hou a i ʻole refractory i rituximab. Ke noiʻi nei ka lua o ka Phase 1/2 i ka BI-1206 i hui pū ʻia me ka anti-PD1 therapy Keytruda® (pembrolizumab) i nā ʻōpū paʻa.

Ua ʻōlelo ʻo Kauka Wei-Wu He, ka luna hoʻomalu o CASI, a me ka Luna Nui, "Ke hoʻomau nei ʻo BioInvent i ka holomua me ka hoʻomohala ʻana a me ka hoʻolālā hoʻoponopono no BI-1206. ʻO ka ʻae ʻana o ka CTA ma Kina i Dekemaba 2021 a me ka FDA Orphan Drug Designation hou e hōʻike ana i ka ikaika o kēia antibody papa mua. Loaʻa iā CASI nā kuleana kālepa Kina o BI-1026, a ke hoʻomākaukau nei kā mākou hui no ke aʻo ʻana o Kina. ʻO CASI a me BioInvent he mau hoa pili ʻole a loaʻa iā lākou ka pahuhopu maʻamau e pōmaikaʻi i nā poʻe maʻi me nā ʻenehana lāʻau lapaʻau hou.

He aha e lawe ʻia mai kēia ʻatikala:

  • One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab.
  • The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody.
  • A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors.

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Linda Hohnholz

Lunahooponopono no eTurboNews ma ka eTN HQ.

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