Serum Institute of India Inks Large-Scale Supply Deal For BCG Use In ImmunityBio's Bladder Cancer Combo Therapy
Serum Institute of India Inks Large-Scale Supply Deal For BCG Use In ImmunityBio's Bladder Cancer Combo Therapy
ImmunityBio Inc (NASDAQ:IBRX) shares are trading down after an early morning high on Friday after the company announced an exclusive global arrangement with the Serum Institute of India, the world's largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG).
ImmunityBio Inc（納斯達克股票代碼：IBRX）股價在週五清晨創下高點後下跌，此前該公司宣佈與印度血清研究所達成獨家全球協議，印度血清研究所是全球產量最大的疫苗製造商，向ImmunityBio供應卡梅特-格林芽孢桿菌（BCG）。
Increasing the available supply of BCG is intended to address shortages for the combination therapy with Anktiva.
增加卡介苗的可用供應旨在解決與Anktiva聯合療法的短缺問題。
The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., and a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications.
該協議涵蓋了目前獲准在美國境外使用的標準卡介苗（sBCG）的生產，以及正在測試的下一代重組卡介苗（iBCG），旨在與ImmunityBio的Anktiva（nogapendekin alfa inbakicept-pmln）聯合使用，用於當前批准的和潛在的未來適應症。
In April, the FDA approved Anktiva plus BCG for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
4月，美國食品藥品管理局批准Anktiva plus BCG用於治療伴有原位癌、伴有或沒有乳頭狀腫瘤的卡介苗無反應的非肌肉浸潤性膀胱癌。
The arrangement will result in additional supplies of the current standard sBCG immediately for trials.
該安排將立即增加當前標準sBCG的供應以供試驗。
At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe.
同時，兩家公司將努力加快目前正在歐洲進行的iBCG二期臨床試驗。
Originally used as a tuberculosis vaccine, BCG administered via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer since 1977.
卡介苗最初用作結核疫苗，自1977年以來，通過膀胱內滴注（通過導管輸送到膀胱）接種一直是非肌肉浸潤性膀胱癌患者的標準護理。
BCG is a benign bacterium that induces an immune response in the bladder near the cancer cells, leading to cancer clearance in many patients.
卡介苗是一種良性細菌，可在癌細胞附近的膀胱中誘發免疫反應，從而使許多患者清除癌症。
BCG is one of the most widely used vaccines worldwide and has been given to over 4 billion individuals.
卡介苗是全球使用最廣泛的疫苗之一，已爲超過40億人接種。
SII is the largest manufacturer of BCG vaccine across the world, while Merck & Co Inc (NYSE:MRK) currently is the only manufacturer of BCG (TICE BCG) in the U.S.
SII是全球最大的卡介苗製造商，而默沙東公司（紐約證券交易所代碼：MRK）目前是美國唯一的卡介苗（TICE BCG）製造商。
ImmunityBio plans to conduct clinical trials to study recombinant BCG (iBCG) and sBCG manufactured by Serum Institute in combination with Anktiva for different types of bladder and other cancers.
ImmunityBio計劃進行臨床試驗，研究血清研究所與Anktiva聯合生產的用於不同類型膀胱癌和其他癌症的重組卡介苗（iBCG）和sBCG。
The supply of BCG is expected to be available once the FDA has authorized the trial protocol. ImmunityBio plans to submit the protocol to the FDA and global regulatory bodies in 30 days.
一旦美國食品和藥物管理局批准了試驗方案，卡介苗的供應有望上市。ImmunityBio計劃在30天內將該協議提交給美國食品藥品管理局和全球監管機構。
IBRX Price Action: ImmunityBio shares are down 0.056% at $8.97 at publication Friday.
IBRX價格走勢：週五公佈時，ImmunityBio股價下跌0.056％，至8.97美元。
Photo: Myriams-Fotos from Pixabay
照片：來自 Pixabay 的 Myriams-Fotos
譯文內容由第三人軟體翻譯。