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Centessa Pharmaceuticals Announces FDA Clearance Of IND Application For Phase 1/2a Clinical Trial Of LB101, First LockBody Candidate, For Solid Tumors

Centessa Pharmaceuticals Announces FDA Clearance Of IND Application For Phase 1/2a Clinical Trial Of LB101, First LockBody Candidate, For Solid Tumors

琴莎製藥宣佈對實體腫瘤第一個鎖體候選人 LB101 1/2a 期臨床試驗的 IND 申請許可
Benzinga Real-time News ·  2023/01/26 09:10

Centessa Pharmaceuticals plc (NASDAQ:CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors. LB101, a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company's proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity.

致力於發現和開發對患者具有變革作用的藥物的臨床階段製藥公司Centessa PharmPharmticals Plc(納斯達克代碼:CNTA)今天宣佈,它已獲得美國食品和藥物管理局(FDA)的批准,將啟動LB101治療實體腫瘤的1/2a期首個人類臨床試驗。LB101是一種針對實體腫瘤的有條件的四價PD-L1xCD47 LockBody雙特異性單抗,是使用該公司的LockBody專利技術開發的第一個候選產品,該技術旨在選擇性地在腫瘤微環境(TME)中驅動潛在的效應器功能活動,如CD47,同時避免全身毒性。

"We are very excited to be bringing our first LockBody candidate to the clinic and to be advancing a potentially transformative technology for patients with solid tumors," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "The clearance of our IND for LB101 is an important milestone for our company as we have an ambitious strategy to advance multiple potential LockBody candidates in areas where there is a significant need for new cancer treatment options. We look forward to initiating the Phase 1/2a trial of LB101 as soon as possible."

Centessa公司首席執行官Saurabh Saha醫學博士說:“我們非常高興能將我們的第一個LockBody候選產品帶到臨床,並為實體腫瘤患者推進一項潛在的變革性技術。批准我們的IND用於LB101對我們公司來說是一個重要的里程碑,因為我們有一個雄心勃勃的戰略,在對新的癌症治療方案有重大需求的地區推進多個潛在的LockBody候選者。我們期待著儘快啟動LB101的1/2a階段試驗。“

About LB101
LB101 is a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor.

關於LB101
LB101是一種條件性四價PD-L1xCD47 LockBody雙特異性單抗,具有兩個被兩個抗PD-L1結構域阻斷的抗CD47結構域,以及連接抗CD47和抗PD-L1結構域的專有人免疫球蛋白衍生鉸鏈。殺傷細胞的作用機制CD47被設計為被PD-L1腫瘤靶向域阻斷,直到免疫球蛋白衍生的鉸鏈在TME中自然降解,從而解鎖和激活腫瘤中的CD47效應器功能活性。

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